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  • page44
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      • sortstudy_title
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• trial_statuses(array)
  • 1Recruiting
  • 2Not yet recruiting
  • 3Suspended
  • 4Stopped
  • 5Completed
  • 6In follow-up
  • 7Analysing
  • 8Writing-up
  • 9Application withdrawn
• applications(array)
  • 0(array)
    • Application(array)
      • id1481
      • user_id263
      • trial_status_id1
      • abstract_of_study<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n This rollover study will be conducted primarily to enable continued access to CAB LA + RPV LA and also to</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n collect long-term safety and tolerability data as specified in the Schedule of Activities in</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n participants who completed the parent studies and who at the time of rollover, experience and are</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n expected to continue to experience clinical benefit from the regimen, and have no other access to</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n locally available CAB LA + RPV LA.</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n At the time of rollover, the investigator should assess whether the participant still benefit</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n clinically from CAB LA + RPV LA treatment according to the antiviral activity and safety criteria</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n as set out in the protocol of the parent study that the participant was participating in prior to this</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n rollover study. The investigator should also be confident that the participant is expected to continue</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n to experience clinical benefit from CAB LA + RPV LA treatment.</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n Participation in the rollover study is voluntary, and the decision to participate must be made jointly</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n by the investigator and the participant or legally acceptable representative. Participants who do not</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n opt to transition to the rollover study at the end of the CAREs study will be switched to SOC ART</p>\n<p style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n per local regulations and availability.</p>\n
      • study_title<p>\n A Phase 4, Open-Label, Rollover Study to Provide Continued Access to Cabotegravir Long-acting Injection and Rilpivirine Long-acting Injection to Participants Living with Human Immunodeficiency Virus Type 1 (HIV-1) Infection Who Participated in Long-acting Combination Therapy Studies</p>\n
      • laymans_summary<p>\n <span style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">Cabotegravir (CAB) is a potent integrase strand transfer inhibitor (INSTI) with attributes allowing formulation and delivery as a long-acting (LA) parenteral product. Rilpivirine (RPV), also formulated as a LA product, is a diarylpyrimidine derivative and a potent non-nucleoside reverse transcriptase inhibitor (NNRTI) with in vitro activity against wild type HIV-1 and select NNRTI-resistant mutants. The combination of CAB LA and RPV LA has been shown in clinical trials in virologically suppressed adults living with HIV to be safe, well-tolerated and efficacious as a complete injectable antiretroviral regimen. This study enables continued CAB LA + RPV LA access to participants who were included in the clinical development studies for CAB LA + RPV LA (IMPAACT 2017 [MOCHA], IMPAACT 2036 [CRAYON], IMPAACT 2040 [CREATE], TMC278LAHTX3002 [CARES], TMC278LAHTX3005 [IMPALA], in the following sections referred to as the parent studies) and who continue to benefit clinically from the regimen but do not have access to locally available CAB LA + RPV LA to continue treatment. The rollover study will be reviewed periodically to evaluate other access options. </span></p>\n
      • short_titleCabotegravir + Rilpivirine Inj
      • protocol_noECCT/24/10/04
      • version_noOriginal Version
      • date_of_protocol12-01-2024
      • study_drugCabotegravir + Rilpivirine Inj
      • disease_conditionHIV AIDS
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameTMC 278
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressamina.salim@iqvia.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample0
      • applicant_gcp_training1
      • applicant_dsmb_charter0
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantJoyce Chelulei
      • declaration_date123-10-2024
      • declaration_principal_investigatorDr. Josphat Kosgei
      • declaration_date223-10-2024
      • placebo_presentNo
      • study_objectives<div>\n  </div>\n<div>\n <table class=\"table table-condensed\" font-size:=\"\" style=\"max-width: 100%; border-collapse: collapse; border-spacing: 0px; width: 917.271px; margin-bottom: 20px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <tbody>\n <tr>\n <td style=\"vertical-align: top; padding: 4px 5px; line-height: 20px; border-top-style: solid; border-top-color: rgb(221, 221, 221);\">\n <p style=\"margin: 0px 0px 10px;\">\n Primary Objective</p>\n <p style=\"margin: 0px 0px 10px;\">\n The primary objective of the study is to provide continued CAB LA + RPV LA access to participants who were enrolled and treated with CAB LA + RPV LA in the parent studies, and who, at the time of rollover, experience and are expected to continue to experience clinical benefit from this treatment.</p>\n <p style=\"margin: 0px 0px 10px;\">\n  </p>\n <p style=\"margin: 0px 0px 10px;\">\n Secondary Objective</p>\n <p style=\"margin: 0px 0px 10px;\">\n The secondary objective is to assess the long-term safety and tolerability of CAB LA + RPV LA by evaluating the incidence of serious adverse events (SAEs), pregnancies, adverse events (AEs) leading to discontinuation of CAB LA + RPV LA and AEs considered to be related to the study intervention.</p>\n </td>\n </tr>\n </tbody>\n </table>\n</div>\n<p>\n  </p>\n
      • principal_inclusion_criteria<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 1. Participants (or their legally acceptable representative) must sign an ICF indicating that they understand the purpose of, and procedures required for the study and are willing to participate in the study. Assent is also required of children capable of understanding the nature of the study (in keeping with local regulations) as described in Section 10.2.3. TMC278(rilpivirine) Clinical Protocol TMC278LAHTX4002 Original CONFIDENTIAL –FOIA Exemptions Apply in U.S. 15 Status: Approved, Date: 12 January 2024</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 2. Participants living with HIV-1 infection who were treated with CAB LA + RPV LA in any of the following parent studies: TMC278LAHTX3002 (CARES), TMC278LAHTX3005 (IMPALA), IMPAACT 2017 (MOCHA), IMPAACT 2036 (CRAYON), IMPAACT 2040 (CREATE), and completed the protocol-defined treatment period.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 3. Has benefited clinically from treatment with CAB LA + RPV LA in the opinion of the investigator and will continue to benefit clinically from this intervention.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 4. Must be able and willing to comply with the rollover protocol requirements.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 5. Participant’s general medical condition, in the opinion of the investigator, does not interfere with participation in this study.</p>\n
      • principal_exclusion_criteria<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Any potential participant who meets any of the following criteria will be excluded from participating in the study:</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 1. Participants using disallowed concomitant treatment (see Section 6.9).</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 2. Participants who were withdrawn from the previous parent study with CAB LA + RPV LA that they were participating in prior to this rollover study, based on any of the mandatory withdrawal criteria.</p>\n
      • primary_end_points<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n The end of study is considered as the last visit for the last participant in the study. The final data from the study site will be sent to the sponsor (or designee) after completion of the final participant visit at that study site, in the time frame specified in the Clinical Trial Agreement.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Participants who prematurely discontinue study intervention for any reason before study completion can be considered to have completed the study if they have completed all the scheduled assessments at that time-point.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety0
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p style=\"margin-left:.5pt;\">\n The U.S. Army Medical Research Directorate-Africa (USAMRD-A) is a Special Foreign Activity of the Walter Reed Army Institute of Research (WRAIR), Washington, DC. USAMRD-</p>\n<p style=\"margin-left:.5pt;\">\n K is affiliated through a Cooperative Agreement with the Kenya Medical Research Institute (KEMRI). The unit was activated on a temporary basis in 1969 at the invitation of the Government of Kenya to study trypanosomiasis. The success of that initial venture led to the establishment of a permanent activity in 1973. Over the past 46 years, research has been conducted on malaria, polio, trypanosomiasis, leishmaniasis, entomology, HIV/AIDS, enteric diseases and arboviruses, with more than 250 manuscripts published. Kericho is located among the African Highlands in the Kenya’s Rift Valley region and well known for the growing of tea that forms the rolling “seas of green” within the tea plantations. The primary industry in this region is tea farming, with two large international tea companies namely Finlay’s Kenya Ltd. and Unilever Tea Kenya Ltd. being centered in Kericho County. Income in Kericho comes mainly from agricultural activities, with about 40-50% of the population living below the poverty line. The annual national gross domestic product per capita in 2005 averaged Kenyan shillings (Kshs) 35,045 (equivalent to 350.45 United States dollar (USD) at current exchange rates of 1 USD = Ksh 100). According to 2019 population census, Kericho County has a population of 901,777 and an area of 2,111 km2 , with a population density of 365.40 persons/km2 . In Kenya, the age of majority (i.e. legal age of recognized adulthood or independence) is 18 years. The Kenyan national literacy level according the Kenya Adult Literacy Survey report published in March 2007 by the Kenya National Bureau of Statistics was 64%. In Kericho, the literacy level is 74.3% in men and 68.9% in women. The healthcare system in the larger Kericho area (southern Rift Valley) is primarily provided by the government through a network of public hospitals, health centers, and dispensaries ran by the Kenya Ministry of Health. The government health facilities do not charge for treatment but levy a small fee for facility maintenance, which can be waived for those not able to pay. In addition to government health care facilities, there are a few faith based and private health care facilities providing services at a small fee. Access to most health care facilities is good given that there exists a fairly reliable public transport system in the region. The site has a long-standing experience in conducting several studies including clinical trials, ranging from therapeutics that included a study of the safety and impact of broadly neutralizing monoclonal antibody therapy with VRC01 on viremia in acute HIV infection, alone or in combination with antiretroviral therapy (ART), vaccines (HIV, Polio, Ebola, Shigella) and cohort studies. The clinical trials range from phase I to IV with age ranges from birth to the elderly, some of which are randomized double blind, placebo controlled and United States Investigational New Drug (IND)/ Food and Drug Administration (FDA)- regulated. The Kericho CRC is equipped with two emergency rooms with equipment and medications to provide immediate emergency care in the event of emergencies and provisions (resuscitation equipment) are in place for immediate resuscitation on site. Additionally, the Kericho site has a standby, fully equipped ambulance for evacuation of participants for more specialized care when necessary. The study staff (clinicians/nurses) are trained on handling emergencies. For inpatient services, participants will be hospitalized at Unilever Tea Kenya (UTK) Central Hospital which is a private company facility owned by the UTK tea company. The site has been using UTK hospital as a satellite site for inpatient admissions of participants requiring inpatient services. The hospital is located about two kilometers from the CRC and has both outpatient and inpatient services.</p>\n
      • other_details_explanation<p>\n <span font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">This is a Phase 4, non-randomized, open-label, multicenter, multicountry, rollover study in participants living with HIV-1 infection who were treated in the parent studies.Based on the number of participants in the parent studies, a maximum of 710 participants (adults, adolescents and children) are expected to potentially rollover into the current study for continued access to CAB LA + RPV LA from study centers in Botswana, Kenya, South Africa, Uganda and Thailand.</span></p>\n
      • other_details_regulatory_notapproved<p>\n Uganda National Drug Authority</p>\n
      • other_details_regulatory_approved<p>\n <strong>Regulatory Authority:</strong></p>\n<p>\n Botswana Medicines & Regulatory Authority</p>\n<p>\n <strong>Country:</strong> Botswana</p>\n<p>\n <strong>Dates of Approval:</strong> 18 June 2024.</p>\n<p>\n <strong>Sites:</strong></p>\n<ol>\n <li>\n Gaborone CRS, Botswana Harvard AIDS Institute Partnership.</li>\n <li>\n Princess Marina Hospital Grounds & Botswana, Molepolole Princess Marina Hospital Grounds, Gaborone, Botswana</li>\n</ol>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration24 Months
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states6
      • number_of_sites5
      • multi_country_listBotswana, Uganda, Thailand, South Africa
      • data_monitoring_committeeNo
      • total_enrolment_per_site40
      • total_participants_worldwide1790
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentYes
      • subjects_specifyMinors
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameReena
      • investigator1_middle_name
      • investigator1_family_nameShah
      • investigator1_qualificationMBBS
      • investigator1_professional_addressAga Khan University Hospital
      • investigator1_telephone+254735338003
      • investigator1_emailreena.shah@aku.edu
      • organisations_transferred_Yes
      • number_participants250
      • notification<p>\n Please find below sponsor information regarding Cabotegravir-related files submission status sent on email as per sponsor request. </p>\n<ul>\n <li>\n Submission done by GSK on 21Oct24</li>\n <li>\n Sender: Marwa Mohammed</li>\n <li>\n Subject: Janssen rollover study - TMC278LAHTX4002 (Cabotegravir</li>\n</ul>\n
      • approval_date30-04-2025
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted24-10-2024
      • is_child0
      • unsubmitted1
      • initial_date_submitted24-10-2024
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewer comments have been addressed.
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-09-19 13:48:35
      • created2024-10-19 01:40:38
      • total_sites1
      • ecitizen_invoice324402
    • InvestigatorContact(array)
      • 0(array)
        • id1180
        • application_id1481
        • given_nameJosphat
        • middle_name
        • family_nameKosgei
        • qualificationMD
        • professional_addressKenya Medical Research Institute/Walter Reed Project Clinical Research Centre
        • telephone0729110122
        • emailJosphat.Kosgei@usamru-k.org
        • created2024-10-19 01:41:56
        • modified2025-04-30 15:52:42
    • SiteDetail(array)
      • 0(array)
        • id1804
        • application_id1481
        • county_id35
        • site_nameKenya Medical Research Institute/Walter Reed Project Clinical Research Centre
        • physical_addressOff Hospital Road, Kericho
        • contact_details P.O.BOX 1357-20200
        • contact_personDr. Josphat Kosgei
        • site_capacity(null)
        • misc(null)
        • created2024-10-19 01:41:56
        • modified2025-04-30 15:52:42
        • County(array)
          • id35
          • county_nameKericho
          • created2012-06-15 10:26:16
          • modified2012-06-15 10:26:16
      • 1(array)
        • id1809
        • application_id1481
        • county_id27
        • site_nameSchool of Medicine, College of Health Sciences, Moi University
        • physical_addressSchool of Medicine, College of Health Sciences, Moi University
        • contact_details+254 53 2060850
        • contact_personProf Abraham Siika Site 10002
        • site_capacity(null)
        • misc(null)
        • created2024-10-19 02:43:04
        • modified2025-04-30 15:52:42
        • County(array)
          • id27
          • county_nameUasin Gishu
          • created2012-06-15 10:25:15
          • modified2012-06-15 10:25:15
      • 2(array)
        • id1810
        • application_id1481
        • county_id47
        • site_nameAga Khan University Hospital Nairobi
        • physical_address3rd Parklands Avenue, off Limuru Road
        • contact_details+254 20 366 2107/2109
        • contact_personProf Reena Shah
        • site_capacity(null)
        • misc(null)
        • created2024-10-19 02:43:04
        • modified2025-04-30 15:52:42
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 3(array)
        • id1811
        • application_id1481
        • county_id47
        • site_nameUniversity of Nairobi - Kenyatta National Referral Hospital
        • physical_addressUniversity Way, Nairobi, PO Box 20723-00202, Kenya
        • contact_details+254709824100
        • contact_personDr Loice Achieng
        • site_capacity(null)
        • misc(null)
        • created2024-10-19 02:43:04
        • modified2025-04-30 15:52:42
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 4(array)
        • id1812
        • application_id1481
        • county_id42
        • site_nameUniversity of Nairobi - Jaramogi Oginga Odinga Teaching and Referral Hospital
        • physical_addressJomo Kenyatta Highway, Kaloleni, Kisumu, PO Box 849-40100, Kenya
        • contact_details+254709824100
        • contact_personDr Loice Achieng
        • site_capacity(null)
        • misc(null)
        • created2024-10-19 02:43:04
        • modified2025-04-30 15:52:42
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id789
        • application_id1481
        • sponsorJanssen-Cilag
        • sponsor_typeIndustry
        • contact_personCatherine Michielsens
        • addressTurnhoutseweg 30 2340 Beerse Belgium
        • telephone_number+3214602111
        • fax_number
        • cell_number+3214602111
        • email_addressra-jcisupportoffice@its.jnj.com
        • created2024-10-19 01:41:56
        • modified2025-04-30 15:52:42
  • 1(array)
    • Application(array)
      • id1034
      • user_id693
      • trial_status_id4
      • abstract_of_study<div>\n Sickle cell disease (SCD) is an inherited blood disorder caused by a point mutation in the β globin gene resulting in the formation of “sickle hemoglobin” (HbS), which</div>\n<div>\n polymerizes in the deoxygenated state and leads to red blood cell (RBC) sickling.</div>\n<div>\n Leg ulcers are a common complication of SCD, particularly among individuals with the more severe genotypes. Global prevalence of leg ulcers in the SCD population varies</div>\n<div>\n geographically, with estimates of 14% to 18% in the United States (US) and Europe, 10% to 30% in sub-Saharan Africa, and 30% to 40% in Jamaica and Brazil. There is a large</div>\n<div>\n unmet need for effective treatment for leg ulcers. In a Cochrane review of 5 randomized trials of interventions for treating leg ulcers in patients with SCD, none of the</div>\n<div>\n therapies resulted in complete ulcer healing (Marti-Carvajal, 2014). Current management of SCD leg ulcers relies primarily on the practice approach used for other cutaneous</div>\n<div>\n ulcers, involving debridement, wet to dry dressings, and topical agents.</div>\n<div>\n Voxelotor (previously GBT440) is an HbS polymerization inhibitor that binds to HbS with a 1:1 stoichiometry and exhibits preferential partitioning to RBCs. The binding</div>\n<div>\n increases HbS-oxygen (O2) affinity, stabilizing the oxyhemoglobin (oxyHb) state and inhibiting polymerization. Findings from the HOPE trial (study GBT440-031) suggest that</div>\n<div>\n voxelotor may be an effective treatment for leg ulcers.</div>\n<div>\n The effect of voxelotor on leg ulcer healing and safety will be assessed in participants 12 years of age and older with SCD and active leg ulcer(s) in this study. The study will</div>\n<div>\n be conducted in approximately 80 eligible participants at approximately 10 global clinical trial sites. In our site we plan to recruit at least 20 patients. The primary objective of</div>\n<div>\n this study is to assess the effect of voxelotor and SOC compared to placebo and SOC on leg ulcer healing in participants ≥ 12 years of age with SCD. The secondary objectives</div>\n<div>\n of this study are to evaluate the effect of voxelotor and SOC compared to placebo and SOC on • Time to resolution of target ulcer(s) • Change in total surface area(s) of</div>\n<div>\n target ulcer(s) • Incidence of new ulcers. The proportion of participants achieving resolution of the target ulcer will measure the primary endpoint. The analysis will use a</div>\n<div>\n Cochran-Mantel-Haenszel (CMH) test to compare voxelotor + SOC with placebo + SOC groups, stratified by target ulcer size and target ulcer duration. For the time to</div>\n<div>\n resolution, a stratified log-rank test will be used to compare the treatment groups. A Cox regression model will be used to estimate the hazard ratio between voxelotor +SOC</div>\n<div>\n and placebo + SOC groups, as appropriate. Exploratory endpoints will be summarized by descriptive statistics. Safety Analysis will be performed on all participants receiving</div>\n<div>\n at least 1 dose of study drug.</div>\n
      • study_title<p>\n A Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy of Voxelotor for the Treatment of Leg Ulcers in Patients with Sickle Cell DiseaseA Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy of Voxelotor for the Treatment of Leg Ulcers in Patients with Sickle Cell Disease</p>\n
      • laymans_summary<div>\n Sickle cell disease is an inherited blood abnormality caused by a change in the makeup of the Red blood cell forming genes that result in the clumping of the red cells. These</div>\n<div>\n abnormal red cells tend to change shape and stick to each other and walls of blood vessels whenever they are exposed to low oxygen levels.</div>\n<div>\n Persons with this gene abnormality experience several complications among them being leg ulcers because of damage of blood vessels. The prevalence of the leg ulcers</div>\n<div>\n varies with geographical location and is estimated to be about 30% in Sub Sahara Africa among people with Sickle cell disease (SCD). No data on the prevalence of leg ulcers</div>\n<div>\n in Kenya is available. There are no known effective treatments for leg ulcers in people with SCD. Current management is based on practice guidelines for treating other skin</div>\n<div>\n ulcers which include use of dressings and application of medications on the ulcers and or surgical trimming and cleaning of the wounds.</div>\n<div>\n Voxelotor is medicine that prevents the change on the shape of the red cells that causes clumping of the red cells. In the HOPE trial, though this was not among the main</div>\n<div>\n study objectives, it was found that participants who had initially joined the study with leg ulcers experienced complete resolution of the ulcers and implies that voxelotor may</div>\n<div>\n be useful in management of leg ulcers.</div>\n<div>\n In this study, the effect of voxelotor on leg ulcer healing and safety will be studied in participants 12 years of age and older with SCD and active leg ulcer(s). Eighty (80)</div>\n<div>\n participants will be recruited globally from the approximately 10 global sites. The primary objective of this study is to assess the effect of voxelotor and SOC compared to</div>\n<div>\n placebo and SOC on leg ulcer healing in participants ≥ 12 years of age with SCD. The secondary objectives of this study are to evaluate the effect of voxelotor and SOC</div>\n<div>\n compared to placebo and SOC on: • Time to healing of target ulcer(s) • Change in total surface area(s) of target ulcer(s), incidence of new ulcers. The primary outcome will be</div>\n<div>\n measured by the proportion of participants achieving healing of the target ulcer(s). Exploratory outcomes will be summarized by descriptive statistics. Safety Analysis will be performed on all participants receiving at least 1 dose of study drug.</div>\n<div>\n  </div>\n<div>\n <p>\n  </p>\n <p>\n Sickle cell disease (SCD) is a condition where red blood cells are shaped like a “sickle” (crescent moon) instead of being round. These sickle cells break down more quickly asnd can block blood flow. This makes it harder for the blood to carry oxygen around the body, leading to problems such as anemia (low levels of red blood cells). A complication of SCD includes open sores (“ulcers”) on the legs, likely due to poor blood flow and the breakdown of red blood cells. Leg ulcers are very painful, heal slowly, and even after they heal, often come back again. No therapies are available for treating or managing leg ulcers caused by SCD.</p>\n <p>\n The main purpose of this study was to find out whether voxelotor could help treat leg ulcers in participants with SCD compared to placebo. A placebo does not have any medicine in it, but it looks just like voxelotor</p>\n <p>\n Researchers wanted to know:</p>\n <p>\n · Can voxelotor help treat leg ulcers compared to placebo after 12 weeks of treatment?</p>\n <p>\n  · What medical problems did participants have during the study?</p>\n <p>\n  </p>\n <p>\n This study stopped early and was not completed as planned.</p>\n <p>\n  </p>\n <p>\n  </p>\n <p>\n How was the study done?</p>\n <p>\n During the Screening and Run-in Periods, researchers checked the participants’ health to make sure they could join the study.</p>\n <p>\n After the Screening Period, participants entered the 2-week Run-in Period, wherein researchers checked the participants’ leg ulcers. During this period, participants started wound care for their leg ulcers according to the study plan.</p>\n <p>\n Double-blind Period Researchers used a computer program to randomly divide the participants into 2 groups.</p>\n <p>\n  · Voxelotor Group: Participants took voxelotor tablets once per day.</p>\n <p>\n  · Placebo Group: Participants took placebo tablets once per day.</p>\n <p>\n Participants took voxelotor or placebo for 12 weeks while continuing wound care for their leg ulcers according to the study plan. During this period, the participants and researchers did not know to which treatment group the participants were assigned. This is known as the “Double-blind” Period. During this period, researchers looked at the participants’ leg ulcers to answer the main question of the study. </p>\n <p>\n  </p>\n <p>\n  Open-label Period</p>\n <p>\n  </p>\n <p>\n After the 12-week Double-blind Period, participants entered the “Open-label” Period. During this period, the participants and researchers knew that all participants were taking voxelotor. · Voxelotor Group: Participants who took voxelotor in the Double-blind Period continued to take voxelotor. · Delayed Voxelotor Group: Participants who took placebo during the Double-blind Period were switched to start voxelotor. Participants took voxelotor for at least 12 weeks while continuing wound care for their leg ulcers according to the study plan. Participants who completed the 12- week treatment in the Open-label Period could keep taking voxelotor as long as they were receiving clinical benefit as observed by the researchers. Throughout the study, researchers checked on the participants’ health and asked them how they were feeling.</p>\n <p>\n  </p>\n <p>\n The Sponsor ran this study at 19 locations in 3 countries: Brazil, Kenya, and Nigeria.</p>\n <p>\n It began on 30 May 2022 and ended on 22 October 2024.</p>\n <p>\n The study included participants who were at least 12 years old with SCD and had at least 1 leg ulcer.</p>\n <p>\n  · A total of 50 boys/men and 38 girls/women participated.</p>\n <p>\n · All participants were between the ages of 12 and 54 years.</p>\n <p>\n  </p>\n <p>\n Study participants were in the study for about 34 weeks (8 months). The study ran for about 2 years and 4 months before the Sponsor stopped the study. This study stopped early and was not completed as planned.</p>\n</div>\n<div>\n  </div>\n
      • short_titleRESOLVE
      • protocol_noECCT/21/07/01
      • version_noOriginal Version
      • date_of_protocol22-09-2020
      • study_drugVoxelotor (GBT440)
      • disease_conditionTreatment of Leg Ulcers in Patients with Sickle Cell Disease
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameVoxelotor
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressNolufefe.Deliwe@ppd.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantBridget Tshatsinde
      • declaration_date129-06-2021
      • declaration_principal_investigatorDr Bernhards Ogutu
      • declaration_date229-06-2021
      • placebo_presentYes
      • study_objectives<p>\n Primary Objective</p>\n<p>\n The primary objective of this study is to assess the effect of voxelotor and SOC compared to placebo and SOC on leg ulcer healing in participants ≥ 12 years of age with SCD, as measured by the proportion of participants achieving resolution of target ulcer(s) in each treatment group by Week 12.</p>\n<p>\n  </p>\n<p>\n Secondary Objectives</p>\n<p>\n The secondary objectives of this study are to evaluate the effect of voxelotor and SOC compared to placebo and SOC on:</p>\n<ul>\n <li>\n Time to resolution of target ulcer(s)</li>\n <li>\n Change in total surface area(s) of target ulcer(s)</li>\n <li>\n Incidence of new ulcers</li>\n</ul>\n<p>\n Exploratory Objectives</p>\n<p>\n The exploratory objectives will assess the effect of voxelotor and SOC compared to placebo and SOC (or open-label voxelotor and SOC, where applicable) on:</p>\n<ul>\n <li>\n Correlation between change in Hb and target ulcer(s) healing</li>\n <li>\n Correlation between change in hemolytic parameters (% reticulocytes, indirect bilirubin, LDH) and target ulcer(s) healing</li>\n <li>\n Health-related quality of life (HRQOL) using patient-reported outcome (PRO) measures, when available (pending translation and cultural validation requirements)\n <ul>\n <li>\n Patient-Reported Outcome Measurements Information System (PROMIS) Pediatric Profile-37 v2.0/PROMIS-43 v2.1), which measures Physical Functioning, Pain Interference, Pain Behavior, Fatigue, Anxiety, Depression, Ability to Participate in Social Roles and Activities)</li>\n <li>\n Visual analog scale (VAS) assessment of pain level linked to target ulcer(s)</li>\n <li>\n Patient Global Impression of Change (PGIC)</li>\n </ul>\n </li>\n <li>\n Clinician Global Impression of Change (CGIC)</li>\n</ul>\n<p>\n  </p>\n<p>\n Safety Objective</p>\n<p class=\"C-BodyText\">\n <span lang=\"EN-US\">The safety objective is to assess the safety and tolerability of voxelotor compared to placebo based on AEs, clinical laboratory tests, physical examinations, vital signs, and other clinical measures (eg, discontinuations due to AEs, dose reductions).<o:p></o:p></span></p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n  </p>\n
      • principal_inclusion_criteria<p>\n                Inclusion Criteria</p>\n<p>\n Participants who meet all of the following criteria will be eligible for study enrollment:</p>\n<p>\n 1.     Male or female participants with documented diagnosis of SCD (HbSS, HbS/β⁰thalassemia)</p>\n<p>\n 2.     Age 12 years and older</p>\n<p>\n 3.     At least 1 cutaneous ulcer(s) on the lower extremity (leg, ankle, or dorsum of foot) that meets the following criteria:</p>\n<p>\n ·       Duration: ≥ 2 weeks and < 6 months at Screening, and</p>\n<p>\n ·       Size: > 2 cm² prior to randomization</p>\n<p style=\"margin-left:36.0pt;\">\n Note: Participants with multiple ulcers are eligible for the study. For each participant, target ulcer(s) for evaluation in this study will be identified and tracked. To qualify as a target ulcer, the ulcer must meet the criteria above.</p>\n<p>\n 4.     Participants, who if female and of child-bearing potential, agree to use highly effective methods of contraception from study start to 30 days after the last dose of study drug and who if male, agree to use barrier methods of contraception from study start to 30 days after the last dose of study drug</p>\n<p>\n 5.     Females of child-bearing potential are required to have a negative pregnancy test before the administration of study drug.</p>\n<p>\n Written informed consent (≥ 18 years) or parental/guardian consent and participant assent (≥ 12–17 years) per IEC policy and requirements, consistent with International Council for Harmonisation (ICH) guidelines</p>\n
      • principal_exclusion_criteria<p>\n Exclusion Criteria</p>\n<p>\n Participants meeting any of the following exclusion criteria will not be eligible for study enrollment:</p>\n<ol>\n <li>\n Target ulcer(s) healed by ≥ 25% during the SOC Run-in prior to randomization</li>\n</ol>\n<p style=\"margin-left:36.0pt;\">\n Note: For participants with multiple ulcers, the participant is not eligible for the study if all target ulcers have healed by ≥ 25% during the SOC Run-in.</p>\n<ol>\n <li value=\"2\">\n Active infection/purulence at ulcer site, or exposed tendon or bone at the ulcer site, based on Investigator’s clinical judgment</li>\n <li value=\"3\">\n Current osteomyelitis at or near the ulcer site</li>\n <li value=\"4\">\n Known vascular abnormalities that would preclude healing in the opinion of the Investigator (eg, pre-existing severe arterial insufficiency in the affected limb)</li>\n <li value=\"5\">\n Serum albumin < 2.0 g/dL</li>\n <li value=\"6\">\n RBC transfusion within 60 days of initiation of study drug</li>\n <li value=\"7\">\n Receiving regularly scheduled RBC transfusion therapy (also termed chronic, prophylactic, or preventive transfusion) during the study</li>\n <li value=\"8\">\n Planned elective surgery within the next 6 months</li>\n <li value=\"9\">\n Anemia due to bone marrow failure (eg, myelodysplasia)</li>\n <li value=\"10\">\n Absolute reticulocyte count < 100 × 10⁹/L</li>\n <li value=\"11\">\n Screening ALT > 4 × upper limit of normal (ULN)</li>\n <li value=\"12\">\n Severe renal dysfunction (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m² by Schwartz formula) or is on chronic dialysis</li>\n <li value=\"13\">\n Clinically significant bacterial, fungal, parasitic, or viral infection that requires therapy:</li>\n</ol>\n<ul>\n <li>\n Participants with acute bacterial infection requiring systemic antibiotic use should delay screening/enrollment until the course of antibiotic therapy has been completed.</li>\n <li>\n Participants with known active hepatitis A, B, or C or who are known to be human immunodeficiency virus (HIV) positive</li>\n <li>\n Participants with active SARS-CoV-2 infection (COVID-19)</li>\n</ul>\n<ol>\n <li value=\"14\">\n Females who are breast-feeding or pregnant</li>\n <li value=\"15\">\n History of hematopoietic stem cell transplant or gene therapy</li>\n <li value=\"16\">\n Participated in another clinical trial of an investigational product (or medical device) within 30 days or 5 half-lives of date of informed consent, whichever is longer, or is currently participating in another trial of an investigational product (or medical device)</li>\n <li value=\"17\">\n Medical, psychological, or behavioral condition that, in the opinion of the Investigator, would confound or interfere with evaluation of safety and/or efficacy of the study drug, prevent compliance with the study protocol; preclude informed consent; or render the participant unable/unlikely to comply with the study procedures</li>\n <li value=\"18\">\n Use of herbal medications (eg, St. John’s Wort), sensitive cytochrome P450 (CYP) 3A4 substrates with a narrow therapeutic index, strong CYP3A4 inhibitors, fluconazole, or moderate or strong CYP3A4 inducers</li>\n</ol>\n<p>\n  </p>\n
      • primary_end_points<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><u>Primary Endpoint</u></span></span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">The primary endpoint will be measured by the proportion of participants achieving resolution of the target ulcer(s), defined as skin re-epithelialization confirmed at 2 consecutive study visits 2 weeks apart during the 12-week Randomized Treatment Period. To qualify as an event, ulcer re‑epithelialization that is first assessed at Week 12 must be confirmed at Week 14.</span></span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">For participants with more than one target ulcer, all target ulcers must be confirmed resolved in order for the participant to be considered a responder.</span></span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><u>Secondary Endpoints</u></span></span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Key secondary endpoints in this study include a comparison of voxelotor and SOC versus placebo and SOC in:</span></span></p>\n<ul>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Time (in days) to resolution of target ulcer(s) up to Week 12</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Change from baseline in total surface area of target ulcer(s) at Week 12</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Incidence of new ulcers by Week 12</span></span></li>\n</ul>\n<p>\n  </p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Exploratory Endpoints</span></span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Exploratory endpoints include:</span></span></p>\n<ul>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Proportion of participants achieving resolution of target ulcer(s) by Week 24</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Time (in days) to resolution of target ulcer(s) up to Week 24</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Change from baseline in total surface area of target ulcer(s) over time up to Week 24</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Correlation between change in Hb and target ulcer(s) healing at Week 12 and Week 24</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Correlation between change in markers of hemolysis (% reticulocytes, indirect bilirubin, LDH) and target ulcer(s) healing at Week 12 and Week 24</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Change from baseline in PRO HRQOL measures: PROMIS-43 v2.1 (Physical Functioning, Pain Interference, Pain Behavior, Fatigue, Anxiety, Depression, Ability to Participate in Social Roles and Activities) at Week 12 and Week 24</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Change from baseline in pain level linked to target ulcer(s) assessed by VAS at Week 12 and Week 24</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">PGIC score at Week 12 and Week 24</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">CGIC score at Week 12 and Week 24</span></span></li>\n</ul>\n<p>\n  </p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Safety Endpoints</span></span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">The safety endpoints include assessments of AEs, clinical laboratory parameters, physical examinations, and vital signs.</span></span></p>\n<p>\n  </p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic1
      • scope_bioequivalence0
      • scope_dose_response1
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<table border=\"1\" cellpadding=\"1\" cellspacing=\"1\" style=\"width:500px;\">\n <caption>\n Dr Ogutu's Site Capacity</caption>\n <tbody>\n <tr>\n <td>\n Number of Staff</td>\n <td>\n Name of staff</td>\n <td>\n Qualification</td>\n <td>\n Role in the study</td>\n </tr>\n <tr>\n <td>\n 1</td>\n <td>\n Dr Bernhard Ogutu</td>\n <td>\n MBChB, Master of Medicine (MMed) (Paediatrics), PhD (Clinical\n <div>\n Pharmacology)</div>\n </td>\n <td>\n Principal Investigator</td>\n </tr>\n <tr>\n <td>\n 1</td>\n <td>\n Dr Anastacia Omoding</td>\n <td>\n (MMed) (Paediatrics), MBChB, C.P.A 1 & 2</td>\n <td>\n Sub-Investigator</td>\n </tr>\n <tr>\n <td>\n 1</td>\n <td>\n Dr Godfrey Allan Otieno</td>\n <td>\n (MMed) (Paediatrics), MBChB,</td>\n <td>\n Sub-Investigator</td>\n </tr>\n <tr>\n <td>\n 1</td>\n <td>\n Dr Ruth Wasuna</td>\n <td>\n Bachelor of Pharmacy, MBA, PhD in Business Administration</td>\n <td>\n Pharmacist</td>\n </tr>\n <tr>\n <td>\n 1</td>\n <td>\n Dr Elizabeth Opondo</td>\n <td>\n Bachelor of Pharmacy</td>\n <td>\n Pharmacist</td>\n </tr>\n </tbody>\n</table>\n<table border=\"1\" cellpadding=\"1\" cellspacing=\"1\" style=\"width: 500px;\">\n <caption>\n <br />\n Prof Githanga's Site Capacity</caption>\n <tbody>\n <tr>\n <td>\n Number of Staff</td>\n <td>\n Name of staff</td>\n <td>\n Qualification</td>\n <td>\n Role in the study</td>\n </tr>\n <tr>\n <td>\n 1</td>\n <td>\n Prof Jessie Nyokabi Githanga</td>\n <td>\n MBChB, MMed (Path)(UON), FCPath ECSA</td>\n <td>\n Principal Investigator</td>\n </tr>\n <tr>\n <td>\n 1</td>\n <td>\n Dr Joy Githua</td>\n <td>\n MBChB</td>\n <td>\n Sub-Investigator</td>\n </tr>\n <tr>\n <td>\n 1</td>\n <td>\n Dr Doreen Mutua</td>\n <td>\n MBChB</td>\n <td>\n Sub-Investigator</td>\n </tr>\n <tr>\n <td>\n 1</td>\n <td>\n Samuel Madere</td>\n <td>\n Bachelor of Pharmacy</td>\n <td>\n Pharmacist</td>\n </tr>\n </tbody>\n</table>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Please refer to attached Site Specific Addendum for full site capacity information</span></span></p>\n<p color:=\"\" font-size:=\"\" line-height:=\"\" style=\"margin: 10px 0px; font-family: \" text-rendering:=\"\" trebuchet=\"\">\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><u><span style=\"color: rgb(34, 34, 34);\">Strathmore University Medical Centre (SUMC)</span></u></span></span></p>\n<p color:=\"\" font-size:=\"\" line-height:=\"\" style=\"margin: 10px 0px; font-family: \" text-rendering:=\"\" trebuchet=\"\">\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><span style=\"color:#000000;\">The SUMC is designed for clinical trials and has a full clinical laboratory with bioanalytical capability. The Centre is managed by Strathmore University and the Centre for Research in Therapeutic Sciences (CREATES) consortium. The Centre also has a dental unit. The medical centre is staffed by 2 pediatricians, 2 physicians, 2 medical officer, 1 clinical officer, 4 dental surgeons, 3 psychologists, 1 pharmacist, 1 visiting psychiatrist, 1 physician assistant, 4 nurses and 4 laboratory technologists. The facility supports healthcare to university students and staff and also general public. The centre has previously run a SCD clinic every Tuesday</span></span></span></p>\n<div>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">The sickle cell study will be conducted at SUMC, recruitment will occur at the clinic. SUMC is located at Strathmore University in Madaraka Estate of Nairobi west, Nairobi County.</span></span></div>\n<div>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">SUMC will be staffed by qualified research personnel from KEMRI and SUMC. The site has a pharmacy, treatment area, clinical assessment area, data entry area, internal quality control and registration area and space where monitoring can be done. SUMC has a data base from the SCD clinic it previously ran with more than 200 patients on follow up comprising of both adults and children.</span></span></div>\n<div>\n  </div>\n<div>\n <div>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">SUMC is an outpatient facility with a 2-bed holding unit and a separate emergency resuscitation area. The centre serves as a clinical trials facility for both paediatric and adult studies as proposed in this study. The participants who will require inpatient care will be admitted to Coptic Hospital Ngong Road as SUMC already has an existing working arrangement.</span></span></div>\n <div>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">As for sickle cell disease, there is a database in place that has over 200 patients and we hope to base our recruitment on this list. The SUMC is also linked to other private, government, non-governmental and county health facilities, in Nairobi County that take care of patients with SCD. For the care of sickle cell patients, the SCD clinic will work closely with the study team.</span></span></div>\n</div>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">The site has a multidisciplinary study team that comprises specialists and professionals in many fields of medicine including; medical officers, paediatricians, haematologists, oncologists, pathologists, nurses, pharmacists, medical laboratory technologists.  The Team has members who have been trained on the job as study coordinators.  The team members are experienced in clinical trials and have all been trained in Good Clinical Practice and most have successfully participated in several other clinical trials. </span></span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><strong><u>KEMRI Kondele Children’s Hospital</u></strong></span></span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">The Kondele Children’s Hospital is designed for large clinical trials and has a full clinical laboratory including microbiology capability. The hospital is a KEMRI facility managed in collaboration with Jaramogi Oginga Odinga Teaching and Referral Hospital (JOOTRH)</span></span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><strong>Location.</strong></span></span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">The study will be carried out at the KCH which is within Jaramogi Oginga Odinga Teaching and Referral Hospital (JOOTRH). Recruitment will take place at KCH.</span></span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">KCH will be staffed by qualified research personnel from KEMRI.  The site has a pharmacy, vaccination area, clinical assessment area, data entry area, internal quality control and registration area and space where monitoring can be done.</span></span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><strong>Provision of medical care</strong></span></span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">The Kondele Children Hospital is a 71 bed unit hospital run by the Ministry of Health. However, KEMRI doctors’ and other clinical staff currently supplement the clinical care services at this children’s hospital. The Kondele Children’s Hospital offers both outpatient and inpatient services. The outpatient is served by clinical officers (physician assistants) who are the primary (first) contacts with the patients. Those who require inpatient care are admitted to the hospital for further clinical evaluation, treatment and care by the medical team (Paediatricians, Medical Officers, Nurses, and Nutritionists). The unit serves as a clinical trials facility for both paediatric and adult studies as proposed in this study.</span></span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">At KCH, children with sickle cell disease are followed up on a regularly in the weekly sickle cell disease clinic. There is a database of children with SCD that has about over 300 patients, and the study team hope to base the recruitment based on this database. The children’s hospital is part of the Jaramogi Oginga Odinga Teaching and Referral Hospital with medical outpatient clinic and adult inpatient care where some of the older patients with SCD are taken care. The study team will work closely with the hospital clinical team to provide medical care for patients with SCD. The hospital too is surrounded by private, governmental, non-governmental health facilities, in the Kisumu county.   </span></span></p>\n<p>\n  </p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><strong><u>Site personnel roles and responsibilities at Gertrude’s Children’s Hospital,</u></strong></span></span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><u>Principal Investigator </u></span></span></p>\n<ul>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Prof Jessie Githanga</span></span></li>\n</ul>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">A qualified haematologist/clinical pathologist, registered by the Kenya Medical Practitioners and Dentists Board (KMPD).  She will be responsible for the overall conduct of the trial at the study site, budgetary negotiations, administrative actions and communication between Institutional Review Boards, and the sponsor and oversight of patient care. She will oversee the recruitment of the subjects and supervision of the staff.</span></span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><u>Co-Investigator/main coordinator</u></span></span></p>\n<ul>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Dr. Doreen Karimi Mutua</span></span></li>\n</ul>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">A qualified paediatrician, with subspecialty training in paediatric haemato-oncology working at Gertrude’s Children’s Hospital (GCH) and registered by the KMPD.  Dr Mutua will be responsible for clinical care provision of the patients, direct supervision of study staff and will also participate in study recruitment.  Dr Mutua supports PI and has roles that may be delegated such as ethical and sponsor communication and may be delegated related roles.</span></span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><u>Study Coordinator :</u></span></span></p>\n<ul>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Dr Joy Githua</span></span></li>\n</ul>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">A qualified medical officer, registered by the KMPDB working at Gertrude’s Children’s Hospital (GCH). She will be the main coordinator for the study and will be responsible for day to day management of trial aspects including participant recruitment, follows up, safety monitoring, data entry and maintaining the site files and other study records and may be delegated related roles. </span></span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><u>Study Pharmacists</u>:</span></span></p>\n<ul>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Dr Samuel Madere</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Dr Cresencia N. Makokha</span></span></li>\n</ul>\n<p>\n  </p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Qualified pharmacists, registered by the PPB, will be delegated roles of the IP storage and related duties, IP dispensing, processing of import permit for IP and may be delegated related roles.</span></span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><u>Study nurses:</u></span></span></p>\n<ul>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Hannah Wanjiku (assistant study coordinator)</span></span></li>\n</ul>\n<ul>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Felicity Kamundi</span></span></li>\n</ul>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">A registered nurse, registered by the Nursing Council of Kenya,  will be responsible for co-ordinating the patient visits and patient training. The assistant study coordinator will in addition play a role in study coordination.</span></span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><u>Laboratory Manager:</u></span></span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Peninah Chege:</span></span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Laboratory manager registered by the Kenya Medical Laboratory Technologists and Technicians Board (KMLTTB) will coordinate laboratory functions, process the import permits for laboratory items, patient and may be delegated related roles.</span></span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><u>Laboratory technologist/phlebotomist</u></span></span></p>\n<ul>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Charles Muia (technologist)</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Herman Akumu(technologist)</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Joseph Langat (phlebotomist)</span></span></li>\n</ul>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Trained laboratory technologists registered by the KMLTTB, GCP trained. and phlebotomist who will obtain specimens from study participants.  The technologists will perform any local laboratory testing where necessary and package specimens for shipping to Central or other local labs.</span></span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><u>Quality Assurance Officer</u></span></span></p>\n<ul>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Winnie Abuto</span></span></li>\n</ul>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Quality Assurance Officer Nurse registered by the Nursing Council of Kenya, and GCP trained. She will be tasked with ensuring that study documents are quality controlled so that they are Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA) in accordance ICH-GCP guidelines.  She will ensure that staff are alerted to changes in SOPs as necessary.</span></span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><u>Administrative assistant</u></span></span></p>\n<ul>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Truphena Otinyo</span></span></li>\n</ul>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">The Administrative assistant will coordinate and maintain the records of communications with the ERC, assist the main coordinator in patient visit coordination.  She may be delegated related roles.</span></span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">The site has a multidisciplinary study team that comprises specialists and professionals in many fields of medicine including; medical officers, paediatricians, haematologists, oncologists, pathologists, nurses, pharmacists, medical laboratory technologists.  The Team has members who have been trained on the job as study coordinators.  The team members are experienced in clinical trials and have all been trained in Good Clinical Practice and most have successfully participated in several other clinical trials. </span></span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><em>Site personnel roles and responsibilities</em></span></span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><u>Principal Investigator </u></span></span></p>\n<ul>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Prof Jessie Githanga</span></span></li>\n</ul>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">A qualified haematologist/clinical pathologist, registered by the Kenya Medical Practitioners and Dentists Board (KMPD).  She will be responsible for the overall conduct of the trial at the study site, budgetary negotiations, administrative actions and communication between Institutional Review Boards, and the sponsor and oversight of patient care. She will oversee the recruitment of the subjects and supervision of the staff.</span></span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><u>Co-Investigator/main coordinator</u></span></span></p>\n<ul>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Dr. Doreen Karimi Mutua</span></span></li>\n</ul>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">A qualified paediatrician, with subspecialty training in paediatric haemato-oncology working at Gertrude’s Children’s Hospital (GCH) and registered by the KMPD.  Dr Mutua will be responsible for clinical care provision of the patients, direct supervision of study staff and will also participate in study recruitment.  Dr Mutua supports PI and has roles that may be delegated such as ethical and sponsor communication and may be delegated related roles.</span></span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><u>Study Coordinator :</u></span></span></p>\n<ul>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Dr Joy Githua</span></span></li>\n</ul>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">A qualified medical officer, registered by the KMPDB working at Gertrude’s Children’s Hospital (GCH). She will be the main coordinator for the study and will be responsible for day to day management of trial aspects including participant recruitment, follows up, safety monitoring, data entry and maintaining the site files and other study records and may be delegated related roles. </span></span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><u>Study Pharmacists</u>:</span></span></p>\n<ul>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Dr Samuel Madere</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Dr Cresencia N. Makokha</span></span></li>\n</ul>\n<p>\n  </p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Qualified pharmacists, registered by the PPB, will be delegated roles of the IP storage and related duties, IP dispensing, processing of import permit for IP and may be delegated related roles.</span></span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><u>Study nurses:</u></span></span></p>\n<ul>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Hannah Wanjiku (assistant study coordinator)</span></span></li>\n</ul>\n<ul>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Felicity Kamundi</span></span></li>\n</ul>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">A registered nurse, registered by the Nursing Council of Kenya,  will be responsible for co-ordinating the patient visits and patient training. The assistant study coordinator will in addition play a role in study coordination.</span></span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><u>Laboratory Manager:</u></span></span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Peninah Chege:</span></span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Laboratory manager registered by the Kenya Medical Laboratory Technologists and Technicians Board (KMLTTB) will coordinate laboratory functions, process the import permits for laboratory items, patient and may be delegated related roles.</span></span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><u>Laboratory technologist/phlebotomist</u></span></span></p>\n<ul>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Charles Muia (technologist)</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Herman Akumu(technologist)</span></span></li>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Joseph Langat (phlebotomist)</span></span></li>\n</ul>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Trained laboratory technologists registered by the KMLTTB, GCP trained. and phlebotomist who will obtain specimens from study participants.  The technologists will perform any local laboratory testing where necessary and package specimens for shipping to Central or other local labs.</span></span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><u>Quality Assurance Officer</u></span></span></p>\n<ul>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Winnie Abuto</span></span></li>\n</ul>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Quality Assurance Officer Nurse registered by the Nursing Council of Kenya, and GCP trained. She will be tasked with ensuring that study documents are quality controlled so that they are Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA) in accordance ICH-GCP guidelines.  She will ensure that staff are alerted to changes in SOPs as necessary.</span></span></p>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\"><u>Administrative assistant</u></span></span></p>\n<ul>\n <li>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">Truphena Otinyo</span></span></li>\n</ul>\n<p>\n <span style=\"font-size:12px;\"><span style=\"font-family:arial,helvetica,sans-serif;\">The Administrative assistant will coordinate and maintain the records of communications with the ERC, assist the main coordinator in patient visit coordination.  She may be delegated related roles.</span></span></p>\n
      • other_details_explanation<p>\n This study is being conducted worldwide in different regions.</p>\n
      • other_details_regulatory_notapproved<p>\n National Agency for Food and Drug Administration and Control (Nigeria) - date of application was 03 February 2021.</p>\n
      • other_details_regulatory_approved<p>\n The study is not yet approved by any Regulatory Authorities.</p>\n<p>\n 6 sites submitted in Nigeria.</p>\n
      • other_details_regulatory_rejected<p>\n Not Applicable</p>\n
      • other_details_regulatory_halted<p>\n Not Applicable</p>\n
      • estimated_duration2 Years
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorPlacebo controlled
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states2 Countries
      • number_of_sites6
      • multi_country_listKenya and Nigeria
      • data_monitoring_committeeNo
      • total_enrolment_per_siteminimum 10 and maximum 20 per site
      • total_participants_worldwide80
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationYes
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameBernhards
      • investigator1_middle_name
      • investigator1_family_nameOgutu
      • investigator1_qualificationMBchB, MMed (Peds), PhD
      • investigator1_professional_addressP.O BOX 59857-00200
      • investigator1_telephone+254733812613
      • investigator1_emailogutu6@gmail.com
      • organisations_transferred_Yes
      • number_participants30
      • notification
      • approval_date10-11-2021
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted02-07-2021
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe application has been approved by the experts
      • final_report<p>\n Number of Study Center(s) and Investigator(s):</p>\n<p>\n A total of 206 participants were screened at 17 centers in 3 countries, and 88 participants were randomized at 16 centers. A list of study centers and investigators involved in this study is provided in Appendix 16.1.4.1.</p>\n<p>\n Publications: None.</p>\n<p>\n Brief Description of the Trial Design and Methodology:</p>\n<p>\n This study was a Phase 3, multicenter, randomized, placebo-controlled study to evaluate the efficacy of voxelotor and standard of care (SOC) for the treatment of leg ulcers in participants with sickle cell disease (SCD). The study was divided into 5 study periods: Screening, Run-in, blinded Randomized Treatment, Open-Label Treatment, and Follow-up/End of Study After the Screening Period, participants entered a 2-week Run-in Period (Day -14 to Day -1 [+3 days]), during which assessments, including target leg ulcer surface area measurements by digital photography were conducted and SOC was initiated per protocol, following best practices. After completion of Run-in period, eligible participants were stratified, at the time of randomization (Day 1), by target ulcers(s) size (<8 cm2 versus ≥8 cm2) and duration (<9 weeks versus ≥9 weeks) at presentation to evenly balance factors known to affect the likelihood of healing. For participants with 1 target ulcer, stratification was based on the total target ulcer surface area (ie, sum of all target ulcer surface areas) and longest duration of any individual target ulcer(s) present. The Randomized Treatment Period was considered the continuous 12 weeks of voxelotor and SOC, or placebo and SOC treatment from date of randomization (first dose, Day 1). The target leg ulcer(s) was/were assessed by visual inspection and surface area measurement(s) using digital photography at scheduled visits every 2 weeks during the 12-week Randomized. Treatment Period. Target ulcer resolution was defined as skin re-epithelialization confirmed at 2 consecutive study visits 2 weeks apart. To qualify as an event, ulcer re-epithelialization that was first assessed at Week 12 must be confirmed at Week 14. Participants demonstrating initial ulcer re-epithelialization at Week 12 continued treatment in their assigned treatment group for an additional 2 weeks to confirm ulcer resolution. At the end of the 12-week Randomized Treatment Period, all participants (with the exception of those demonstrating initial ulcer re-epithelialization at Week 12) received open-label voxelotor 1500 mg once a day (QD) and SOC for a minimum 12 weeks and target ulcer(s) that had failed to heal during the initial 12 weeks was/were followed for delayed healing.Participants who had completed 12 weeks in the Open-Label Treatment Period might continue to receive voxelotor as long as they continued to receive clinical benefit that outweighed risk as determined by the investigator or until the participant had access to voxelotor from an alternative source not associated with this protocol (eg, through a clinical Open-Label Extension [OLE] study sponsored by Pfizer, commercialization of the product, or a managed access program). Participants who planned not to continue to receive voxelotor from an alternative source continued to the follow-up period after completing 12 weeks in the Open-Label Treatment Period. This report provides full data of efficacy and safety for all the treated participants at the end of study, ie, last participant last visit (LPLV). Number of Participants (planned and analyzed): Approximately 80 participants were planned and a total of 88 participants were randomized and treated. Two analysis sets were predefined for the study: intent-to-treat (ITT) population, which included all randomized participants; and safety-evaluable population, which included all randomized participants who received at least one dose of study intervention. All of the 88 randomized participants were treated and thus included in both the ITT and safety-evaluable populations. Study Intervention: During the Randomized Treatment Period, participants were randomized in a 1:1 ratio to receive voxelotor 1500 mg QD (500 mg ×3 tablets) or matching placebo orally administered for 12 weeks. During the Open-Label Treatment Period, all participants received voxelotor 1500 mg QD (500 mg ×3 tablets) for a minimum of 12 weeks. In this study, all participants received the SOC per protocol for SCD leg ulcers during the Run-in, Randomized Treatment,and Open-Label Treatment periods. Global Interruptions and Re-starts On 10 May 2024, the administration of the study intervention, voxelotor, was voluntarily paused by Pfizer (the sponsor) due to the overall number of fatal events observed in the studywhich required further assessment of accrued data. On 25 September 2024, voxelotor was voluntarily withdrawn by Pfizer from all markets inwhich it was approved, and all ongoing voxelotor clinical studies and early access and compassionate use programs have been discontinued.</p>\n<p>\n SUMMARY OF RESULTS:</p>\n<p>\n Participant Disposition Of the 206 participants screened, 88 were randomized and treated, including 43 in the placebo group and 45 in the voxelotor group. Of these participants, 79 (89.8%) were in Africa (62 [70.5%] in Kenya and 17 [19.3%] in Nigeria), and 9 (10.2%) were in Latin America (all in Brazil). Out of 88 participants, 2 discontinued the study intervention during the Randomized Treatment Period, both in the voxelotor group, 1 due to AE, and the other due to withdrawal by participant. After the Randomized Treatment Period, 86 out of 88 participants entered the Open-Label Treatment Period. Of the 86 participants, 43 originally randomized to the placebo group received voxelotor (referred to “delayed voxelotor” hereafter), and 43 originally randomized to the voxelotor group continued voxelotor treatment. During the Open-Label Treatment Extension Period (including the Open-Label Treatment Period and the Follow-up Period), 75 (87.2%) participants discontinued study intervention (37 in the delayed voxelotor group and 38 in the voxelotor group), among whom the majority [59 (68.6%) participants] were discontinued due to study termination, and a total of 10 (11.6%) participants discontinued due to AEs (4 in the delayed voxelotor group and 6 in the voxelotor group).</p>\n
      • implication_results<p>\n “There are no changes proposed to the current practice for the treatment of leg ulcers in patients with sickle cell disease at this time.”</p>\n
      • quantity_imported1032
      • quantity_dispensed419
      • quantity_destroyed613
      • quantity_exported0
      • balance_siteo
      • final_date2025-10-24 12:39:30
      • modified2025-10-24 12:39:30
      • created2021-06-29 14:21:43
      • total_sites(null)
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        • id688
        • application_id1034
        • given_nameBernhards
        • middle_nameRagama
        • family_nameOgutu
        • qualificationMBchB, MMed (Peds), PhD
        • professional_addressP.O BOX 59857-00200
        • telephone+254733812613
        • emailogutu6@gmail.com
        • created2021-06-29 14:33:47
        • modified2021-07-02 20:34:34
      • 1(array)
        • id689
        • application_id1034
        • given_nameJessie
        • middle_nameNyokabi
        • family_nameGithanga
        • qualificationMBChB, MMed (Path)(UON), FCPath ECSA Associate Professor
        • professional_addressP. O. Box 19676-00200, Nairobi, Kenya
        • telephone+254 721245721
        • emailJessie.githanga@uonbi.ac.ke
        • created2021-06-29 14:41:47
        • modified2021-07-02 20:34:34
    • SiteDetail(array)
      • 0(array)
        • id1065
        • application_id1034
        • county_id47
        • site_nameStrathmore University Medical Center
        • physical_addressOle Sangale Road P.O Box 59857-00200
        • contact_detailsOle Sangale Road P.O Box 59857-00200, Tel: 254 (0) 703 034375
        • contact_personVictoria Sidi
        • site_capacity(null)
        • misc(null)
        • created2021-06-29 14:33:47
        • modified2021-07-02 20:34:34
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 1(array)
        • id1066
        • application_id1034
        • county_id42
        • site_nameKEMRI Kondele children\'S Hospital
        • physical_addressP.O BOX 6049 40103 Kondele children\'s Hospital
        • contact_detailsP.O BOX 6049 40103 Kondele children\'s Hospital Tel:0724106654
        • contact_personIshmael sports
        • site_capacity(null)
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        • created2021-06-29 14:58:49
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          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
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        • id1067
        • application_id1034
        • county_id47
        • site_nameGertrude\'s Children\'s Hospital
        • physical_address34 Muthaiga road, P.O BOX 42325-00100, Nairobi, Kenya
        • contact_details P.O BOX 42325-00100, Nairobi, Kenya Tel +254 721245721
        • contact_personProfessor Jessie Githanga
        • site_capacity(null)
        • misc(null)
        • created2021-06-29 15:01:34
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          • county_nameNairobi City
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    • Sponsor(array)
      • 0(array)
        • id520
        • application_id1034
        • sponsorGlobal Blood Therapeutics, Inc.
        • sponsor_typeResearch Institution
        • contact_personCarolyn Hoppe, MD, Senior Medical Director
        • addressGlobal Blood Therapeutics, Inc. 181 Oyster Point Blvd South San Francisco, CA 94080 United States of America
        • telephone_number(650) 741-7741
        • fax_number
        • cell_number(650) 741-7741
        • email_addresschoppe@gbt.com
        • created2021-06-29 14:33:47
        • modified2021-07-02 20:34:34
  • 2(array)
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      • id1053
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      • trial_status_id4
      • abstract_of_study<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n Sickle cell disease (SCD) is an inherited blood disorder caused by a point mutation in the β globin gene resulting in the formation of “sickle hemoglobin” (HbS), which polymerizes in the deoxygenated state and leads to red blood cell (RBC) sickling.</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n Leg ulcers are a common complication of SCD, particularly among individuals with the more severe genotypes. Global prevalence of leg ulcers in the SCD population varies geographically, with estimates of 14% to 18% in the United States (US) and Europe, 10% to 30% in sub-Saharan Africa, and 30% to 40% in Jamaica and Brazil. There is a large unmet need for effective treatment for leg ulcers. In a Cochrane review of 5 randomized trials of interventions for treating leg ulcers in patients with SCD, none of the therapies resulted in complete ulcer healing (Marti-Carvajal, 2014). Current management of SCD leg ulcers relies primarily on the practice approach used for other cutaneous ulcers, involving debridement, wet to dry dressings, and topical agents.</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n Voxelotor (previously GBT440) is an HbS polymerization inhibitor that binds to HbS with a 1:1 stoichiometry and exhibits preferential partitioning to RBCs. The binding increases HbS-oxygen (O2) affinity, stabilizing the oxyhemoglobin (oxyHb) state and inhibiting polymerization. Findings from the HOPE trial (study GBT440-031) suggest that voxelotor may be an effective treatment for leg ulcers.</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n The effect of voxelotor on leg ulcer healing and safety will be assessed in participants 12 years of age and older with SCD and active leg ulcer(s) in this study. The study will be conducted in approximately 80 eligible participants at approximately 10 global clinical trial sites. In our site we plan to recruit at least 20 patients. The primary objective of this study is to assess the effect of voxelotor and SOC compared to placebo and SOC on leg ulcer healing in participants ≥ 12 years of age with SCD. The secondary objectives of this study are to evaluate the effect of voxelotor and SOC compared to placebo and SOC on • Time to resolution of target ulcer(s) • Change in total surface area(s) of target ulcer(s) • Incidence of new ulcers.</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n The proportion of participants achieving resolution of the target ulcer will measure the primary endpoint. The analysis will use a</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n Cochran-Mantel-Haenszel (CMH) test to compare voxelotor + SOC with placebo + SOC groups, stratified by target ulcer size and target ulcer duration. For the time to resolution, a stratified log-rank test will be used to compare the treatment groups. A Cox regression model will be used to estimate the hazard ratio between voxelotor +SOC and placebo + SOC groups, as appropriate. Exploratory endpoints will be summarized by descriptive statistics. Safety Analysis will be performed on all participants receiving at least 1 dose of study drug.</div>\n
      • study_title<p>\n A Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy of Voxelotor for the Treatment of Leg Ulcers in Patients with Sickle Cell Disease</p>\n
      • laymans_summary<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n Sickle cell disease is an inherited blood abnormality caused by a change in the makeup of the Red blood cell forming genes that result in the clumping of the red cells. These abnormal red cells tend to change shape and stick to each other and walls of blood vessels whenever they are exposed to low oxygen levels.</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n Persons with this gene abnormality experience several complications among them being leg ulcers because of damage of blood vessels. The prevalence of the leg ulcers varies with geographical location and is estimated to be about 30% in Sub Sahara Africa among people with Sickle cell disease (SCD). No data on the prevalence of leg ulcers in Kenya is available. There are no known effective treatments for leg ulcers in people with SCD. Current management is based on practice guidelines for treating other skin ulcers which include use of dressings and application of medications on the ulcers and or surgical trimming and cleaning of the wounds.</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n Voxelotor is medicine that prevents the change on the shape of the red cells that causes clumping of the red cells. In the HOPE trial, though this was not among the main study objectives, it was found that participants who had initially joined the study with leg ulcers experienced complete resolution of the ulcers and implies that voxelotor may be useful in management of leg ulcers.</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n In this study, the effect of voxelotor on leg ulcer healing and safety will be studied in participants 12 years of age and older with SCD and active leg ulcer(s). Eighty (80) participants will be recruited globally from the approximately 10 global sites. The primary objective of this study is to assess the effect of voxelotor and SOC compared to placebo and SOC on leg ulcer healing in participants ≥ 12 years of age with SCD. The secondary objectives of this study are to evaluate the effect of voxelotor and SOC compared to placebo and SOC on: • Time to healing of target ulcer(s) • Change in total surface area(s) of target ulcer(s), incidence of new ulcers. The primary outcome will be measured by the proportion of participants achieving healing of the target ulcer(s). Exploratory outcomes will be summarized by descriptive statistics. Safety Analysis will be performed on all participants receiving at least 1 dose of study drug.</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n  </div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n  </div>\n<p>\n Lay man Summary : Sickle cell disease (SCD) is a condition where red blood cells are shaped like a “sickle” (crescent moon) instead of being round. These sickle cells break down more quickly asnd can block blood flow. This makes it harder for the blood to carry oxygen around the body, leading to problems such as anemia (low levels of red blood cells). A complication of SCD includes open sores (“ulcers”) on the legs, likely due to poor blood flow and the breakdown of red blood cells. Leg ulcers are very painful, heal slowly, and even after they heal, often come back again. No therapies are available for treating or managing leg ulcers caused by SCD. The main purpose of this study was to find out whether voxelotor could help treat leg ulcers in participants with SCD compared to placebo. A placebo does not have any medicine in it, but it looks just like voxelotor Researchers wanted to know: • Can voxelotor help treat leg ulcers compared to placebo after 12 weeks of treatment? • What medical problems did participants have during the study? This study stopped early and was not completed as planned. How was the study done? During the Screening and Run-in Periods, researchers checked the participants’ health to make sure they could join the study. After the Screening Period, participants entered the 2-week Run-in Period, wherein researchers checked the participants’ leg ulcers. During this period, participants started wound care for their leg ulcers according to the study plan. Double-blind Period Researchers used a computer program to randomly divide the participants into 2 groups. • Voxelotor Group: Participants took voxelotor tablets once per day. • Placebo Group: Participants took placebo tablets once per day. Participants took voxelotor or placebo for 12 weeks while continuing wound care for their leg ulcers according to the study plan. During this period, the participants and researchers did not know to which treatment group the participants were assigned. This is known as the “Double-blind” Period. During this period, researchers looked at the participants’ leg ulcers to answer the main question of the study. Open-label Period After the 12-week Double-blind Period, participants entered the “Open-label” Period. During this period, the participants and researchers knew that all participants were taking voxelotor. • Voxelotor Group: Participants who took voxelotor in the Double-blind Period continued to take voxelotor. • Delayed Voxelotor Group: Participants who took placebo during the Double-blind Period were switched to start voxelotor. Participants took voxelotor for at least 12 weeks while continuing wound care for their leg ulcers according to the study plan. Participants who completed the 12- week treatment in the Open-label Period could keep taking voxelotor as long as they were receiving clinical benefit as observed by the researchers. Throughout the study, researchers checked on the participants’ health and asked them how they were feeling. The Sponsor ran this study at 19 locations in 3 countries: Brazil, Kenya, and Nigeria. It began on 30 May 2022 and ended on 22 October 2024. The study included participants who were at least 12 years old with SCD and had at least 1 leg ulcer. • A total of 50 boys/men and 38 girls/women participated. • All participants were between the ages of 12 and 54 years. Study participants were in the study for about 34 weeks (8 months). The study ran for about 2 years and 4 months before the Sponsor stopped the study. This study stopped early and was not completed as planned</p>\n
      • short_titleRESOLVE
      • protocol_noECCT/21/10/02
      • version_noOriginal Version
      • date_of_protocol22-09-2020
      • study_drugVoxelotor (GBT440)
      • disease_conditionTreatment of Leg Ulcers in Patients with Sickle Cell Disease
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameVoxelotor
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressPPDSubmissionsMembers.SM@ppd.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
      • applicant_indemnity_pi1
      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
      • applicant_signed_checklist1
      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantPat Moody
      • declaration_date112-10-2021
      • declaration_principal_investigatorDr Bernhards Ogutu
      • declaration_date212-10-2021
      • placebo_presentYes
      • study_objectives<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Primary Objective</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n The primary objective of this study is to assess the effect of voxelotor and SOC compared to placebo and SOC on leg ulcer healing in participants ≥ 12 years of age with SCD, as measured by the proportion of participants achieving resolution of target ulcer(s) in each treatment group by Week 12.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n  </p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Secondary Objectives</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n The secondary objectives of this study are to evaluate the effect of voxelotor and SOC compared to placebo and SOC on:</p>\n<ul font-size:=\"\" style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <li style=\"line-height: 20px;\">\n Time to resolution of target ulcer(s)</li>\n <li style=\"line-height: 20px;\">\n Change in total surface area(s) of target ulcer(s)</li>\n <li style=\"line-height: 20px;\">\n Incidence of new ulcers</li>\n</ul>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Exploratory Objectives</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n The exploratory objectives will assess the effect of voxelotor and SOC compared to placebo and SOC (or open-label voxelotor and SOC, where applicable) on:</p>\n<ul font-size:=\"\" style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <li style=\"line-height: 20px;\">\n Correlation between change in Hb and target ulcer(s) healing</li>\n <li style=\"line-height: 20px;\">\n Correlation between change in hemolytic parameters (% reticulocytes, indirect bilirubin, LDH) and target ulcer(s) healing</li>\n <li style=\"line-height: 20px;\">\n Health-related quality of life (HRQOL) using patient-reported outcome (PRO) measures, when available (pending translation and cultural validation requirements)\n <ul style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 0px 25px;\">\n <li style=\"line-height: 20px;\">\n Patient-Reported Outcome Measurements Information System (PROMIS) Pediatric Profile-37 v2.0/PROMIS-43 v2.1), which measures Physical Functioning, Pain Interference, Pain Behavior, Fatigue, Anxiety, Depression, Ability to Participate in Social Roles and Activities)</li>\n <li style=\"line-height: 20px;\">\n Visual analog scale (VAS) assessment of pain level linked to target ulcer(s)</li>\n <li style=\"line-height: 20px;\">\n Patient Global Impression of Change (PGIC)</li>\n </ul>\n </li>\n <li style=\"line-height: 20px;\">\n Clinician Global Impression of Change (CGIC)</li>\n</ul>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n  </p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Safety Objective</p>\n<p class=\"C-BodyText\" font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <span lang=\"EN-US\">The safety objective is to assess the safety and tolerability of voxelotor compared to placebo based on AEs, clinical laboratory tests, physical examinations, vital signs, and other clinical measures (eg, discontinuations due to AEs, dose reductions).</span></p>\n
      • principal_inclusion_criteria<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Inclusion Criteria</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Participants who meet all of the following criteria will be eligible for study enrollment:</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 1.     Male or female participants with documented diagnosis of SCD (HbSS, HbS/β<span style=\"position: relative; font-size: 9.375px; line-height: 0; vertical-align: baseline; top: -0.5em;\">0 </span>thalassemia)</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 2.     Age 12 years and older</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 3.     At least 1 cutaneous ulcer(s) on the lower extremity (leg, ankle, or dorsum of foot) that meets the following criteria:</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n ·       Duration: ≥ 2 weeks and < 6 months at Screening, and</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n ·       Size: > 2 cm<span style=\"position: relative; font-size: 9.375px; line-height: 0; vertical-align: baseline; top: -0.5em;\">2</span> prior to randomization</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px 36pt; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Note: Participants with multiple ulcers are eligible for the study. For each participant, target ulcer(s) for evaluation in this study will be identified and tracked. To qualify as a target ulcer, the ulcer must meet the criteria above.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 4.     Participants, who if female and of child-bearing potential, agree to use highly effective methods of contraception from study start to 30 days after the last dose of study drug and who if male, agree to use barrier methods of contraception from study start to 30 days after the last dose of study drug</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 5.     Females of child-bearing potential are required to have a negative pregnancy test before the administration of study drug.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Written informed consent (≥ 18 years) or parental/guardian consent and participant assent (≥ 12–17 years) per IEC policy and requirements, consistent with International Council for Harmonisation (ICH) guidelines.</p>\n
      • principal_exclusion_criteria<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Exclusion Criteria</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Participants meeting any of the following exclusion criteria will not be eligible for study enrollment:</p>\n<ol font-size:=\"\" style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <li style=\"line-height: 20px;\">\n Target ulcer(s) healed by ≥ 25% during the SOC Run-in prior to randomization</li>\n</ol>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px 36pt; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n Note: For participants with multiple ulcers, the participant is not eligible for the study if all target ulcers have healed by ≥ 25% during the SOC Run-in.</p>\n<ol font-size:=\"\" style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <li style=\"line-height: 20px;\" value=\"2\">\n Active infection/purulence at ulcer site, or exposed tendon or bone at the ulcer site, based on Investigator’s clinical judgment</li>\n <li style=\"line-height: 20px;\" value=\"3\">\n Current osteomyelitis at or near the ulcer site</li>\n <li style=\"line-height: 20px;\" value=\"4\">\n Known vascular abnormalities that would preclude healing in the opinion of the Investigator (eg, pre-existing severe arterial insufficiency in the affected limb)</li>\n <li style=\"line-height: 20px;\" value=\"5\">\n Serum albumin < 2.0 g/dL</li>\n <li style=\"line-height: 20px;\" value=\"6\">\n RBC transfusion within 60 days of initiation of study drug</li>\n <li style=\"line-height: 20px;\" value=\"7\">\n Receiving regularly scheduled RBC transfusion therapy (also termed chronic, prophylactic, or preventive transfusion) during the study</li>\n <li style=\"line-height: 20px;\" value=\"8\">\n Planned elective surgery within the next 6 months</li>\n <li style=\"line-height: 20px;\" value=\"9\">\n Anemia due to bone marrow failure (eg, myelodysplasia)</li>\n <li style=\"line-height: 20px;\" value=\"10\">\n Absolute reticulocyte count < 100 × 10<span style=\"position: relative; font-size: 9.375px; line-height: 0; vertical-align: baseline; top: -0.5em;\">9</span>/L</li>\n <li style=\"line-height: 20px;\" value=\"11\">\n Screening ALT > 4 × upper limit of normal (ULN)</li>\n <li style=\"line-height: 20px;\" value=\"12\">\n Severe renal dysfunction (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m<span style=\"position: relative; font-size: 9.375px; line-height: 0; vertical-align: baseline; top: -0.5em;\">2</span> by Schwartz formula) or is on chronic dialysis</li>\n <li style=\"line-height: 20px;\" value=\"13\">\n Clinically significant bacterial, fungal, parasitic, or viral infection that requires therapy:</li>\n</ol>\n<ul font-size:=\"\" style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <li style=\"line-height: 20px;\">\n Participants with acute bacterial infection requiring systemic antibiotic use should delay screening/enrollment until the course of antibiotic therapy has been completed.</li>\n <li style=\"line-height: 20px;\">\n Participants with known active hepatitis A, B, or C or who are known to be human immunodeficiency virus (HIV) positive</li>\n <li style=\"line-height: 20px;\">\n Participants with active SARS-CoV-2 infection (COVID-19)</li>\n</ul>\n<ol font-size:=\"\" style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <li style=\"line-height: 20px;\" value=\"14\">\n Females who are breast-feeding or pregnant</li>\n <li style=\"line-height: 20px;\" value=\"15\">\n History of hematopoietic stem cell transplant or gene therapy</li>\n <li style=\"line-height: 20px;\" value=\"16\">\n Participated in another clinical trial of an investigational product (or medical device) within 30 days or 5 half-lives of date of informed consent, whichever is longer, or is currently participating in another trial of an investigational product (or medical device)</li>\n <li style=\"line-height: 20px;\" value=\"17\">\n Medical, psychological, or behavioral condition that, in the opinion of the Investigator, would confound or interfere with evaluation of safety and/or efficacy of the study drug, prevent compliance with the study protocol; preclude informed consent; or render the participant unable/unlikely to comply with the study procedures</li>\n <li style=\"line-height: 20px;\" value=\"18\">\n Use of herbal medications (eg, St. John’s Wort), sensitive cytochrome P450 (CYP) 3A4 substrates with a narrow therapeutic index, strong CYP3A4 inhibitors, fluconazole, or moderate or strong CYP3A4 inducers</li>\n</ol>\n
      • primary_end_points<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial, helvetica, sans-serif;\"><u>Primary Endpoint</u></span></span></p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial, helvetica, sans-serif;\">The primary endpoint will be measured by the proportion of participants achieving resolution of the target ulcer(s), defined as skin re-epithelialization confirmed at 2 consecutive study visits 2 weeks apart during the 12-week Randomized Treatment Period. To qualify as an event, ulcer re‑epithelialization that is first assessed at Week 12 must be confirmed at Week 14.</span></span></p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial, helvetica, sans-serif;\">For participants with more than one target ulcer, all target ulcers must be confirmed resolved in order for the participant to be considered a responder.</span></span></p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial, helvetica, sans-serif;\"><u>Secondary Endpoints</u></span></span></p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial, helvetica, sans-serif;\">Key secondary endpoints in this study include a comparison of voxelotor and SOC versus placebo and SOC in:</span></span></p>\n<ul font-size:=\"\" style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <li style=\"line-height: 20px;\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial, helvetica, sans-serif;\">Time (in days) to resolution of target ulcer(s) up to Week 12</span></span></li>\n <li style=\"line-height: 20px;\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial, helvetica, sans-serif;\">Change from baseline in total surface area of target ulcer(s) at Week 12</span></span></li>\n <li style=\"line-height: 20px;\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial, helvetica, sans-serif;\">Incidence of new ulcers by Week 12</span></span></li>\n</ul>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n  </p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial, helvetica, sans-serif;\">Exploratory Endpoints</span></span></p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial, helvetica, sans-serif;\">Exploratory endpoints include:</span></span></p>\n<ul font-size:=\"\" style=\"padding-right: 0px; padding-left: 0px; margin: 0px 0px 10px 25px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <li style=\"line-height: 20px;\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial, helvetica, sans-serif;\">Proportion of participants achieving resolution of target ulcer(s) by Week 24</span></span></li>\n <li style=\"line-height: 20px;\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial, helvetica, sans-serif;\">Time (in days) to resolution of target ulcer(s) up to Week 24</span></span></li>\n <li style=\"line-height: 20px;\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial, helvetica, sans-serif;\">Change from baseline in total surface area of target ulcer(s) over time up to Week 24</span></span></li>\n <li style=\"line-height: 20px;\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial, helvetica, sans-serif;\">Correlation between change in Hb and target ulcer(s) healing at Week 12 and Week 24</span></span></li>\n <li style=\"line-height: 20px;\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial, helvetica, sans-serif;\">Correlation between change in markers of hemolysis (% reticulocytes, indirect bilirubin, LDH) and target ulcer(s) healing at Week 12 and Week 24</span></span></li>\n <li style=\"line-height: 20px;\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial, helvetica, sans-serif;\">Change from baseline in PRO HRQOL measures: PROMIS-43 v2.1 (Physical Functioning, Pain Interference, Pain Behavior, Fatigue, Anxiety, Depression, Ability to Participate in Social Roles and Activities) at Week 12 and Week 24</span></span></li>\n <li style=\"line-height: 20px;\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial, helvetica, sans-serif;\">Change from baseline in pain level linked to target ulcer(s) assessed by VAS at Week 12 and Week 24</span></span></li>\n <li style=\"line-height: 20px;\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial, helvetica, sans-serif;\">PGIC score at Week 12 and Week 24</span></span></li>\n <li style=\"line-height: 20px;\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial, helvetica, sans-serif;\">CGIC score at Week 12 and Week 24</span></span></li>\n</ul>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n  </p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial, helvetica, sans-serif;\">Safety Endpoints</span></span></p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n <span style=\"font-size: 12px;\"><span style=\"font-family: arial, helvetica, sans-serif;\">The safety endpoints include assessments of AEs, clinical laboratory parameters, physical examinations, and vital signs.</span></span></p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic1
      • scope_bioequivalence0
      • scope_dose_response1
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n The study will be carried out at the KEMRI CCR - Butere County Hospital site. The site is housed in Butere County Hospital (BCH) which is designed for preventive and curative care for patients and has the capacity for regulated clinical trials. It has a pharmacy, a clinical laboratory which is able to carry out tests in house and also outsource services. The site has a vaccination area, clinical assessment area, data entry area, internal quality control and registration area and adequate space where monitoring can be done. Site has a research team comprising of different cadres and works closely with personnel working in the Ministry of Health facilities within the study area. Trained Community Health Workers will assist with study activities conducted in the field. It is located in Butere sub-county, Kakamega County. The hospital is a satellite unit of KEMRI-CCR in a relatively research naïve community. The BCH serves as a referral health facility offering both out-patient and in-patient services.</p>\n<p>\n Roles of Investigators</p>\n<p>\n Dr. Janet Nyawira Oyieko will be responsible for the execution of the study at the BCH site in Butere. She will be responsible for the overall clinical conduct of the trial, the care provided to patients and the overall oversight of field activities. She will also be responsible for the clinical data collection activities. She will contribute to the statistical analysis and writing of the scientific report.</p>\n<p>\n Dr. Lucas Otieno Tina will be responsible for the clinical conduct of the trial, the care provided to patients, oversight of field activities. He will contribute to the statistical analysis and writing of scientific report(s).</p>\n<p>\n Dr. Valentine Sing’oei will be responsible for the clinical conduct of the trial, the care provided to patients, oversight of hospital activities. She will contribute to the statistical analysis and writing of scientific report(s).</p>\n<p>\n Dr. Henry Nyongesa Wanyama will be responsible for the clinical conduct of the trial, the care provided to patients, oversight of hospital activities. He will contribute to the statistical analysis and writing of scientific report(s).</p>\n<p>\n Dorothy Carolyne Mabunde, the clinical research coordinator - will be responsible for regulatory activities and study coordination on site.</p>\n
      • other_details_explanation<p>\n <span font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">This study is being conducted worldwide in different regions.</span></p>\n
      • other_details_regulatory_notapproved<p>\n <span font-size:=\"\" style=\"color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">National Agency for Food and Drug Administration and Control (Nigeria) - date of application was 03 February 2021.</span></p>\n
      • other_details_regulatory_approved<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n The study is not yet approved by any Regulatory Authorities.</p>\n<p font-size:=\"\" style=\"margin: 0px 0px 10px; color: rgb(51, 51, 51); font-family: \" trebuchet=\"\">\n 6 sites submitted in Nigeria.</p>\n
      • other_details_regulatory_rejected<p>\n Not Applicable</p>\n
      • other_details_regulatory_halted<p>\n Not Applicable</p>\n
      • estimated_duration2 Years
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorPlacebo controlled
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states2 Countries
      • number_of_sites6
      • multi_country_listKenya and Nigeria
      • data_monitoring_committeeNo
      • total_enrolment_per_siteminimum 10 and maximum 20 per site
      • total_participants_worldwide80
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationYes
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameBernhards
      • investigator1_middle_name
      • investigator1_family_nameOgutu
      • investigator1_qualificationMBchB, MMed (Peds), PhD
      • investigator1_professional_addressP.O BOX 59857-00200
      • investigator1_telephone+254733812613
      • investigator1_emailogutu6@gmail.com
      • organisations_transferred_Yes
      • number_participants30
      • notification
      • approval_date14-07-2022
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted21-06-2022
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe applicant responses to reviewer queries have been reviewed and considered adequate.
      • final_report<p>\n <strong>Number of Study Center(s) and Investigator(s)</strong>:</p>\n<p>\n A total of 206 participants were screened at 17 centers in 3 countries, and 88 participants were randomized at 16 centers. A list of study centers and investigators involved in this study is provided in Appendix 16.1.4.1.</p>\n<p>\n Publications: None.</p>\n<p>\n Brief Description of the Trial Design and Methodology: This study was a Phase 3, multicenter, randomized, placebo-controlled study to evaluate the efficacy of voxelotor and standard of care (SOC) for the treatment of leg ulcers in participants with sickle cell disease (SCD). The study was divided into 5 study periods: Screening, Run-in, blinded Randomized Treatment, Open-Label Treatment, and Follow-up/End of Study After the Screening Period, participants entered a 2-week Run-in Period (Day -14 to Day -1 [+3 days]), during which assessments, including target leg ulcer surface area measurements by digital photography were conducted and SOC was initiated per protocol, following best practices. After completion of Run-in period, eligible participants were stratified, at the time of randomization (Day 1), by target ulcers(s) size (<8 cm2 versus ≥8 cm2) and duration (<9 weeks versus ≥9 weeks) at presentation to evenly balance factors known to affect the likelihood of healing. For participants with 1 target ulcer, stratification was based on the total target ulcer surface area (ie, sum of all target ulcer surface areas) and longest duration of any individual target ulcer(s) present.</p>\n<p>\n The Randomized Treatment Period was considered the continuous 12 weeks of voxelotor and SOC, or placebo and SOC treatment from date of randomization (first dose, Day 1). The target leg ulcer(s) was/were assessed by visual inspection and surface area measurement(s) using digital photography at scheduled visits every 2 weeks during the 12-week Randomized. Treatment Period. Target ulcer resolution was defined as skin re-epithelialization confirmed at 2 consecutive study visits 2 weeks apart. To qualify as an event, ulcer re-epithelialization that was first assessed at Week 12 must be confirmed at Week 14. Participants demonstrating initial ulcer re-epithelialization at Week 12 continued treatment in their assigned treatment group for an additional 2 weeks to confirm ulcer resolution. At the end of the 12-week Randomized Treatment Period, all participants (with the exception of those demonstrating initial ulcer re-epithelialization at Week 12) received open-label voxelotor 1500 mg once a day (QD) and SOC for a minimum 12 weeks and target ulcer(s) that had failed to heal during the initial 12 weeks was/were followed for delayed healing.Participants who had completed 12 weeks in the Open-Label Treatment Period might continue to receive voxelotor as long as they continued to receive clinical benefit that outweighed risk as determined by the investigator or until the participant had access to voxelotor from an alternative source not associated with this protocol (eg, through a clinical Open-Label Extension [OLE] study sponsored by Pfizer, commercialization of the product, or a managed access program). Participants who planned not to continue to receive voxelotor from an alternative source continued to the follow-up period after completing 12 weeks in the Open-Label Treatment Period. This report provides full data of efficacy and safety for all the treated participants at the end of study, ie, last participant last visit (LPLV). Number of Participants (planned and analyzed): Approximately 80 participants were planned and a total of 88 participants were randomized and treated. Two analysis sets were predefined for the study: intent-to-treat (ITT) population, which included all randomized participants; and safety-evaluable population, which included all randomized participants who received at least one dose of study intervention. All of the 88 randomized participants were treated and thus included in both the ITT and safety-evaluable populations. Study Intervention: During the Randomized Treatment Period, participants were randomized in a 1:1 ratio to receive voxelotor 1500 mg QD (500 mg ×3 tablets) or matching placebo orally administered for 12 weeks.</p>\n<p>\n During the Open-Label Treatment Period, all participants received voxelotor 1500 mg QD (500 mg ×3 tablets) for a minimum of 12 weeks. In this study, all participants received the SOC per protocol for SCD leg ulcers during the Run-in, Randomized Treatment,and Open-Label Treatment periods.</p>\n<p>\n <strong>Global Interruptions and Re-starts</strong></p>\n<p>\n On 10 May 2024, the administration of the study intervention, voxelotor, was voluntarily paused by Pfizer (the sponsor) due to the overall number of fatal events observed in the studywhich required further assessment of accrued data. On 25 September 2024, voxelotor was voluntarily withdrawn by Pfizer from all markets inwhich it was approved, and all ongoing voxelotor clinical studies and early access and compassionate use programs have been discontinued.</p>\n<p>\n <strong>SUMMARY OF RESULTS:</strong></p>\n<p>\n Participant Disposition Of the 206 participants screened, 88 were randomized and treated, including 43 in the placebo group and 45 in the voxelotor group. Of these participants, 79 (89.8%) were in Africa (62 [70.5%] in Kenya and 17 [19.3%] in Nigeria), and 9 (10.2%) were in Latin America (all in Brazil). Out of 88 participants, 2 discontinued the study intervention during the Randomized Treatment Period, both in the voxelotor group, 1 due to AE, and the other due to withdrawal by participant. After the Randomized Treatment Period, 86 out of 88 participants entered the Open-Label Treatment Period. Of the 86 participants, 43 originally randomized to the placebo group received voxelotor (referred to “delayed voxelotor” hereafter), and 43 originally randomized to the voxelotor group continued voxelotor treatment. During the Open-Label Treatment Extension Period (including the Open-Label Treatment Period and the Follow-up Period), 75 (87.2%) participants discontinued study intervention (37 in the delayed voxelotor group and 38 in the voxelotor group), among whom the majority [59 (68.6%) participants] were discontinued due to study termination, and a total of 10 (11.6%) participants discontinued due to AEs (4 in the delayed voxelotor group and 6 in the voxelotor group).</p>\n
      • implication_results<p>\n <strong><em>“There are no changes proposed to the current practice for the treatment of leg ulcers in patients with sickle cell disease at this time.”</em></strong></p>\n<p>\n  </p>\n
      • quantity_imported727
      • quantity_dispensed327
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      • quantity_exported0
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      • final_date2025-10-24 12:33:29
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        • given_nameJanet
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        • family_nameOyieko
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        • professional_addressP. O. Box 54 – 40100, Kisumu, Kenya
        • telephone+254 721 996 988
        • emailjanet.oyieko@gmail.com
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        • physical_addressalong Shaitsala-Sabatia Road Walter Reed Project-Kombewa, off Kisumu-Bondo Road. P. O. Box 54 – 40100
        • contact_detailsP. O. Box 54 – 40100. Telno: +254 721 996 988
        • contact_personDr Janet Oyieko
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        • site_nameStrathmore University
        • physical_addressOle Sangale Road, Madaraka Estate
        • contact_detailsPO Box 59857-00200. Telno: +254 733 813 613
        • contact_personDr Bernhards Ogutu
        • site_capacity(null)
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        • site_nameKEMRI Kondele Children’s Hospital
        • physical_addressKisumu-kakamega Road, Kisumu
        • contact_detailsP.O. Box, 54-40100. Telno: +254 733 813 613
        • contact_personDr Bernhards Ogutu
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        • site_nameKEMRI/CRDR Siaya Clinical Research Annex
        • physical_addressSiaya County Hospital Hospital road, Siaya, Kenya
        • contact_detailsP.O Box 144-40600. Telno: +254790484654
        • contact_personDr Videlis Nduba
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        • site_nameKEMRI CRDR Clinical Research Clinic Nairobi
        • physical_addressKenyatta National Hospital Off Hospital Road
        • contact_detailsP.O Box 47855-00100. Telno: +254790484654
        • contact_personDr Videlis Nduba
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        • site_nameGertrude’s Children’s Hospital
        • physical_address34 Muthaiga Rd, Nairobi, Kenya
        • contact_detailsPO BOX 42325-00100. Telno: +254 721245721
        • contact_personProf Jessie Githanga
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        • sponsorGlobal Blood Therapeutics, Inc.
        • sponsor_typeResearch Institution
        • contact_personCarolyn Hoppe, MD, Senior Medical Director
        • addressGlobal Blood Therapeutics, Inc. 181 Oyster Point Blvd South San Francisco, CA 94080 United States of America
        • telephone_number(650) 741-7741
        • fax_number
        • cell_number(650) 741-7741
        • email_addresschoppe@gbt.com
        • created2021-08-30 11:07:01
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      • abstract_of_study<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n Sickle cell disease (SCD) is an inherited blood disorder caused by a point mutation in the β globin gene resulting in the formation of “sickle hemoglobin” (HbS), which</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n polymerizes in the deoxygenated state and leads to red blood cell (RBC) sickling.</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n Leg ulcers are a common complication of SCD, particularly among individuals with the more severe genotypes. Global prevalence of leg ulcers in the SCD population varies</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n geographically, with estimates of 14% to 18% in the United States (US) and Europe, 10% to 30% in sub-Saharan Africa, and 30% to 40% in Jamaica and Brazil. There is a large</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n unmet need for effective treatment for leg ulcers. In a Cochrane review of 5 randomized trials of interventions for treating leg ulcers in patients with SCD, none of the</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n therapies resulted in complete ulcer healing (Marti-Carvajal, 2014). Current management of SCD leg ulcers relies primarily on the practice approach used for other cutaneous</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n ulcers, involving debridement, wet to dry dressings, and topical agents.</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n Voxelotor (previously GBT440) is an HbS polymerization inhibitor that binds to HbS with a 1:1 stoichiometry and exhibits preferential partitioning to RBCs. The binding</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n increases HbS-oxygen (O2) affinity, stabilizing the oxyhemoglobin (oxyHb) state and inhibiting polymerization. Findings from the HOPE trial (study GBT440-031) suggest that</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n voxelotor may be an effective treatment for leg ulcers.</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n The effect of voxelotor on leg ulcer healing and safety will be assessed in participants 12 years of age and older with SCD and active leg ulcer(s) in this study. The study will</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n be conducted in approximately 80 eligible participants at approximately 10 global clinical trial sites. In our site we plan to recruit at least 20 patients. The primary objective of</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n this study is to assess the effect of voxelotor and SOC compared to placebo and SOC on leg ulcer healing in participants ≥ 12 years of age with SCD. The secondary objectives</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n of this study are to evaluate the effect of voxelotor and SOC compared to placebo and SOC on • Time to resolution of target ulcer(s) • Change in total surface area(s) of</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n target ulcer(s) • Incidence of new ulcers. The proportion of participants achieving resolution of the target ulcer will measure the primary endpoint. The analysis will use a</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n Cochran-Mantel-Haenszel (CMH) test to compare voxelotor + SOC with placebo + SOC groups, stratified by target ulcer size and target ulcer duration. For the time to</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n resolution, a stratified log-rank test will be used to compare the treatment groups. A Cox regression model will be used to estimate the hazard ratio between voxelotor +SOC</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n and placebo + SOC groups, as appropriate. Exploratory endpoints will be summarized by descriptive statistics. Safety Analysis will be performed on all participants receiving</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n at least 1 dose of study drug.</div>\n
      • study_title<p>\n A Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy of Voxelotor for the Treatment of Leg Ulcers in Patients with Sickle Cell Disease </p>\n
      • laymans_summary<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n Sickle cell disease is an inherited blood abnormality caused by a change in the makeup of the Red blood cell forming genes that result in the clumping of the red cells. These</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n abnormal red cells tend to change shape and stick to each other and walls of blood vessels whenever they are exposed to low oxygen levels.</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n Persons with this gene abnormality experience several complications among them being leg ulcers because of damage of blood vessels. The prevalence of the leg ulcers</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n varies with geographical location and is estimated to be about 30% in Sub Sahara Africa among people with Sickle cell disease (SCD). No data on the prevalence of leg ulcers</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n in Kenya is available. There are no known effective treatments for leg ulcers in people with SCD. Current management is based on practice guidelines for treating other skin</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n ulcers which include use of dressings and application of medications on the ulcers and or surgical trimming and cleaning of the wounds.</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n Voxelotor is medicine that prevents the change on the shape of the red cells that causes clumping of the red cells. In the HOPE trial, though this was not among the main</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n study objectives, it was found that participants who had initially joined the study with leg ulcers experienced complete resolution of the ulcers and implies that voxelotor may</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n be useful in management of leg ulcers.</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n In this study, the effect of voxelotor on leg ulcer healing and safety will be studied in participants 12 years of age and older with SCD and active leg ulcer(s). Eighty (80)</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n participants will be recruited globally from the approximately 10 global sites. The primary objective of this study is to assess the effect of voxelotor and SOC compared to</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n placebo and SOC on leg ulcer healing in participants ≥ 12 years of age with SCD. The secondary objectives of this study are to evaluate the effect of voxelotor and SOC</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n compared to placebo and SOC on: • Time to healing of target ulcer(s) • Change in total surface area(s) of target ulcer(s), incidence of new ulcers. The primary outcome will be</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n measured by the proportion of participants achieving healing of the target ulcer(s). Exploratory outcomes will be summarized by descriptive statistics. Safety Analysis will beperformed on all participants receiving at least 1 dose of study drug.</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n  </div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n <p>\n Sickle cell disease (SCD) is a condition where red blood cells are shaped like a “sickle” (crescent moon) instead of being round. These sickle cells break down more quickly asnd can block blood flow. This makes it harder for the blood to carry oxygen around the body, leading to problems such as anemia (low levels of red blood cells). A complication of SCD includes open sores (“ulcers”) on the legs, likely due to poor blood flow and the breakdown of red blood cells. Leg ulcers are very painful, heal slowly, and even after they heal, often come back again. No therapies are available for treating or managing leg ulcers caused by SCD.</p>\n <p>\n The main purpose of this study was to find out whether voxelotor could help treat leg ulcers in participants with SCD compared to placebo. A placebo does not have any medicine in it, but it looks just like voxelotor</p>\n <p>\n Researchers wanted to know:</p>\n <p>\n · Can voxelotor help treat leg ulcers compared to placebo after 12 weeks of treatment?</p>\n <p>\n  · What medical problems did participants have during the study?</p>\n <p>\n  </p>\n <p>\n This study stopped early and was not completed as planned.</p>\n <p>\n  </p>\n <p>\n  </p>\n <p>\n How was the study done?</p>\n <p>\n During the Screening and Run-in Periods, researchers checked the participants’ health to make sure they could join the study.</p>\n <p>\n After the Screening Period, participants entered the 2-week Run-in Period, wherein researchers checked the participants’ leg ulcers. During this period, participants started wound care for their leg ulcers according to the study plan.</p>\n <p>\n Double-blind Period Researchers used a computer program to randomly divide the participants into 2 groups.</p>\n <p>\n  · Voxelotor Group: Participants took voxelotor tablets once per day.</p>\n <p>\n  · Placebo Group: Participants took placebo tablets once per day.</p>\n <p>\n Participants took voxelotor or placebo for 12 weeks while continuing wound care for their leg ulcers according to the study plan. During this period, the participants and researchers did not know to which treatment group the participants were assigned. This is known as the “Double-blind” Period. During this period, researchers looked at the participants’ leg ulcers to answer the main question of the study. </p>\n <p>\n  </p>\n <p>\n  Open-label Period</p>\n <p>\n  </p>\n <p>\n After the 12-week Double-blind Period, participants entered the “Open-label” Period. During this period, the participants and researchers knew that all participants were taking voxelotor. · Voxelotor Group: Participants who took voxelotor in the Double-blind Period continued to take voxelotor. · Delayed Voxelotor Group: Participants who took placebo during the Double-blind Period were switched to start voxelotor. Participants took voxelotor for at least 12 weeks while continuing wound care for their leg ulcers according to the study plan. Participants who completed the 12- week treatment in the Open-label Period could keep taking voxelotor as long as they were receiving clinical benefit as observed by the researchers. Throughout the study, researchers checked on the participants’ health and asked them how they were feeling.</p>\n <p>\n  </p>\n <p>\n The Sponsor ran this study at 19 locations in 3 countries: Brazil, Kenya, and Nigeria.</p>\n <p>\n It began on 30 May 2022 and ended on 22 October 2024.</p>\n <p>\n The study included participants who were at least 12 years old with SCD and had at least 1 leg ulcer.</p>\n <p>\n  · A total of 50 boys/men and 38 girls/women participated.</p>\n <p>\n · All participants were between the ages of 12 and 54 years.</p>\n <p>\n  </p>\n <p>\n Study participants were in the study for about 34 weeks (8 months). The study ran for about 2 years and 4 months before the Sponsor stopped the study. This study stopped early and was not completed as planned.</p>\n</div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n  </div>\n<div style=\"color: rgb(51, 51, 51); font-family: "Trebuchet MS", Tahoma, Verdana, Arial, sans-serif; font-size: 12.5px;\">\n  </div>\n
      • short_titleRESOLVE
      • protocol_noECCT/21/11/06
      • version_noOriginal
      • date_of_protocol22-09-2020
      • study_drugVoxelotor, 500 mg tablets
      • disease_condition Sickle Cell Leg Ulcers
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameVoxelotor
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressPPDSubmissionsMembers.SM@ppd.com
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries(null)
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      • applicant_analysis_cert1
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      • applicant_dsmb_charter1
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      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
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      • applicant_contractual_agreement1
      • declaration_applicantAnel Botha
      • declaration_date112-11-2021
      • declaration_principal_investigatorDr Bernhard Ogutu
      • declaration_date212-11-2021
      • placebo_presentYes
      • study_objectives<p>\n Primary Objective</p>\n<p>\n The primary objective of this study is to assess the effect of voxelotor and SOC compared to placebo and SOC on leg ulcer healing in participants ≥ 12 years of age with SCD, as measured by the proportion of participants achieving resolution of target ulcer(s) in each treatment group by Week 12.</p>\n<p>\n Secondary Objectives</p>\n<p>\n The secondary objectives of this study are to evaluate the effect of voxelotor and SOC compared to placebo and SOC on:</p>\n<ul>\n <li>\n Time to resolution of target ulcer(s)</li>\n <li>\n Change in total surface area(s) of target ulcer(s)</li>\n <li>\n Incidence of new ulcers</li>\n</ul>\n<p>\n Exploratory Objectives</p>\n<p>\n The exploratory objectives will assess the effect of voxelotor and SOC compared to placebo and SOC (or open-label voxelotor and SOC, where applicable) on:</p>\n<ul>\n <li>\n Correlation between change in Hb and target ulcer(s) healing</li>\n <li>\n Correlation between change in hemolytic parameters (% reticulocytes, indirect bilirubin, LDH) and target ulcer(s) healing</li>\n <li>\n Health-related quality of life (HRQOL) using patient-reported outcome (PRO) measures, when available (pending translation and cultural validation requirements)</li>\n <li>\n - Patient-Reported Outcome Measurements Information System (PROMIS) Pediatric Profile-37 v2.0/PROMIS-43 v2.1), which measures Physical Functioning, Pain Interference, Pain Behavior, Fatigue, Anxiety, Depression, Ability to Participate in Social Roles and Activities)</li>\n <li>\n - Visual analog scale (VAS) assessment of pain level linked to target ulcer(s)</li>\n <li>\n -Patient Global Impression of Change (PGIC) Clinician Global Impression of Change (CGIC)</li>\n</ul>\n<p>\n Safety Objective</p>\n<ol>\n <li>\n The safety objective is to assess the safety and tolerability of voxelotor compared to placebo based on AEs, clinical laboratory tests, physical examinations, vital signs, and other clinical measures (eg, discontinuations due to AEs, dose reductions). </li>\n</ol>\n
      • principal_inclusion_criteria<p>\n Inclusion Criteria Participants who meet all of the following criteria will be eligible for study enrollment:</p>\n<p>\n 1. Male or female participants with documented diagnosis of SCD (HbSS, HbS/β thalassemia)</p>\n<p>\n 2. Age 12 years and older</p>\n<p>\n 3. At least 1 cutaneous ulcer(s) on the lower extremity (leg, ankle, or dorsum of foot) that meets the following criteria:</p>\n<p>\n · Duration: ≥ 2 weeks and < 6 months at Screening, and</p>\n<p>\n · Size: > 2 cm prior to randomization</p>\n<p>\n Note: Participants with multiple ulcers are eligible for the study. For each participant, target ulcer(s) for evaluation in this study will be identified and tracked. To qualify as a target ulcer, the ulcer must meet the criteria above.</p>\n<p>\n 4. Participants, who if female and of child-bearing potential, agree to use highly effective methods of contraception from study start to 30 days after the last dose of study drug and who if male, agree to use barrier methods of contraception from study start to 30 days after the last dose of study drug</p>\n<p>\n 5. Females of child-bearing potential are required to have a negative pregnancy test before the administration of study drug.</p>\n<p>\n Written informed consent (≥ 18 years) or parental/guardian consent and participant assent (≥ 12–17 years) per IEC policy and requirements, consistent with International Council for Harmonisation (ICH) guidelines. </p>\n
      • principal_exclusion_criteria<p>\n Exclusion Criteria</p>\n<p>\n Participants meeting any of the following exclusion criteria will not be eligible for study enrollment:</p>\n<p>\n 1. Target ulcer(s) healed by ≥ 25% during the SOC Run-in prior to randomization Note: For participants with multiple ulcers, the participant is not eligible for the study if all target ulcers have healed by ≥ 25% during the SOC Run-in.</p>\n<p>\n 2. Active infection/purulence at ulcer site, or exposed tendon or bone at the ulcer site, based on Investigator’s clinical judgment</p>\n<p>\n 3. Current osteomyelitis at or near the ulcer site</p>\n<p>\n 4. Known vascular abnormalities that would preclude healing in the opinion of the Investigator (eg, pre-existing severe arterial insufficiency in the affected limb)</p>\n<p>\n 5. Serum albumin < 2.0 g/dL</p>\n<p>\n 6. RBC transfusion within 60 days of initiation of study drug</p>\n<p>\n 7. Receiving regularly scheduled RBC transfusion therapy (also termed chronic, prophylactic, or preventive transfusion) during the study</p>\n<p>\n 8. Planned elective surgery within the next 6 months</p>\n<p>\n 9. Anemia due to bone marrow failure (eg, myelodysplasia)</p>\n<p>\n 10. Absolute reticulocyte count < 100 × 10 /L</p>\n<p>\n 11. Screening ALT > 4 × upper limit of normal (ULN)</p>\n<p>\n 12. Severe renal dysfunction (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m by Schwartz formula) or is on chronic dialysis</p>\n<p>\n 13. Clinically significant bacterial, fungal, parasitic, or viral infection that requires therapy: Participants with acute bacterial infection requiring systemic antibiotic use should delay screening/enrollment until the course of antibiotic therapy has been completed. Participants with known active hepatitis A, B, or C or who are known to be human immunodeficiency virus (HIV) positive Participants with active SARS-CoV-2 infection (COVID-19)</p>\n<p>\n 14. Females who are breast-feeding or pregnant</p>\n<p>\n 15. History of hematopoietic stem cell transplant or gene therapy</p>\n<p>\n 16. Participated in another clinical trial of an investigational product (or medical device) within 30 days or 5 half-lives of date of informed consent, whichever is longer, or is currently participating in another trial of an investigational product (or medical device)</p>\n<p>\n 17. Medical, psychological, or behavioral condition that, in the opinion of the Investigator, would confound or interfere with evaluation of safety and/or efficacy of the study drug, prevent compliance with the study protocol; preclude informed consent; or render the participant unable/unlikely to comply with the study procedures</p>\n<p>\n 18. Use of herbal medications (eg, St. John’s Wort), sensitive cytochrome P450 (CYP) 3A4 substrates with a narrow therapeutic index, strong CYP3A4 inhibitors, fluconazole, or moderate or strong CYP3A4 inducers</p>\n
      • primary_end_points<p>\n <u>Primary Endpoint</u></p>\n<p>\n The primary endpoint will be measured by the proportion of participants achieving resolution of the target ulcer(s), defined as skin re-epithelialization confirmed at 2 consecutive study visits 2 weeks apart during the 12-week Randomized Treatment Period. To qualify as an event, ulcer re‑epithelialization that is first assessed at Week 12 must be confirmed at Week 14.</p>\n<p>\n For participants with more than one target ulcer, all target ulcers must be confirmed resolved in order for the participant to be considered a responder.</p>\n<p>\n <u>Secondary Endpoints</u></p>\n<p>\n Key secondary endpoints in this study include a comparison of voxelotor and SOC versus placebo and SOC in:</p>\n<ul>\n <li>\n Time (in days) to resolution of target ulcer(s) up to Week 12</li>\n <li>\n Change from baseline in total surface area of target ulcer(s) at Week 12</li>\n <li>\n Incidence of new ulcers by Week 12</li>\n</ul>\n<p>\n <u>Exploratory Endpoints</u></p>\n<p>\n Exploratory endpoints include:</p>\n<ul>\n <li>\n Proportion of participants achieving resolution of target ulcer(s) by Week 24</li>\n <li>\n Time (in days) to resolution of target ulcer(s) up to Week 24</li>\n <li>\n Change from baseline in total surface area of target ulcer(s) over time up to Week 24</li>\n <li>\n Correlation between change in Hb and target ulcer(s) healing at Week 12 and Week 24</li>\n <li>\n Correlation between change in markers of hemolysis (% reticulocytes, indirect bilirubin, LDH) and target ulcer(s) healing at Week 12 and Week 24</li>\n <li>\n Change from baseline in PRO HRQOL measures: PROMIS-43 v2.1 (Physical Functioning, Pain Interference, Pain Behavior, Fatigue, Anxiety, Depression, Ability to Participate in Social Roles and Activities) at Week 12 and Week 24</li>\n <li>\n Change from baseline in pain level linked to target ulcer(s) assessed by VAS at Week 12 and Week 24</li>\n <li>\n PGIC score at Week 12 and Week 24</li>\n <li>\n CGIC score at Week 12 and Week 24</li>\n</ul>\n<p>\n <u>Safety Endpoints</u></p>\n<p>\n The safety endpoints include assessments of AEs, clinical laboratory parameters, physical examinations, and vital signs.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic1
      • scope_bioequivalence0
      • scope_dose_response1
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n  </p>\n<p>\n Site activities are in Nairobi and Siaya counties. The Nairobi site is located at the Centre for Respiratory Disease Research within the Kenyatta National Referral Hospital Complex. The Siaya site is located in the Siaya county referral hospital within the KEMRI/CRDR clinical research annex.</p>\n<p>\n These sites are well equipped with the facilities required to conduct studies of this nature. In addition, the sites have staff who are qualified by experience and training in conducting clinical trials. The investigational product [IP] will be stored at sites. Recruitment and follow up of study participants as well as study activities will occur at the sites which have the capacity to conduct all phases of clinical trial studies and have adequate facilities and staff to conduct clinical trials.  After community mobilization, screening and enrolment, IP dispensation will occur here as well.</p>\n
      • other_details_explanation<p>\n This study is being conducted worldwide in different regions.</p>\n
      • other_details_regulatory_notapproved<p>\n National Agency for Food and Drug Administration and Control (Nigeria) - date of application was 03 February 2021.</p>\n
      • other_details_regulatory_approved<p>\n The study is not yet approved by any Regulatory Authorities.</p>\n<p>\n 6 sites submitted in Nigeria.</p>\n
      • other_details_regulatory_rejected<p>\n Not Applicable</p>\n
      • other_details_regulatory_halted<p>\n Not Applicable</p>\n
      • estimated_duration2 years
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorPlacebo
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_statestwo Countries
      • number_of_sites6
      • multi_country_listKenya and Nigeria
      • data_monitoring_committeeNo
      • total_enrolment_per_siteminimum 10 and maximum 20 per site
      • total_participants_worldwide80
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsYes
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationYes
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameBernhards
      • investigator1_middle_name
      • investigator1_family_nameOgutu
      • investigator1_qualificationMBcHB, MMED (Peds), PhD
      • investigator1_professional_address KEMRI/CRDR Kenyatta National Hospital Off Hospital Road P.O Box 47855-00100 Nairobi-Kenya
      • investigator1_telephone+254790484654
      • investigator1_emailVNduba@kemri.org
      • organisations_transferred_Yes
      • number_participants30
      • notification
      • approval_date20-05-2022
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted24-02-2022
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe study is similar to approved study No. ECCT/21/07/01. The SSA has been considered adequate
      • final_report<p>\n <strong>Number of Study Center(s) and Investigator(s)</strong>:</p>\n<p>\n A total of 206 participants were screened at 17 centers in 3 countries, and 88 participants were randomized at 16 centers. A list of study centers and investigators involved in this study is provided in Appendix 16.1.4.1.</p>\n<p>\n <strong>Publications</strong>: None.</p>\n<p>\n <strong>Brief Description of the Trial Design and Methodology</strong>:</p>\n<p>\n This study was a Phase 3, multicenter, randomized, placebo-controlled study to evaluate the efficacy of voxelotor and standard of care (SOC) for the treatment of leg ulcers in participants with sickle cell disease (SCD). The study was divided into 5 study periods: Screening, Run-in, blinded Randomized Treatment, Open-Label Treatment, and Follow-up/End of Study After the Screening Period, participants entered a 2-week Run-in Period (Day -14 to Day -1 [+3 days]), during which assessments, including target leg ulcer surface area measurements by digital photography were conducted and SOC was initiated per protocol, following best practices. After completion of Run-in period, eligible participants were stratified, at the time of randomization (Day 1), by target ulcers(s) size (<8 cm2 versus ≥8 cm2) and duration (<9 weeks versus ≥9 weeks) at presentation to evenly balance factors known to affect the likelihood of healing. For participants with 1 target ulcer, stratification was based on the total target ulcer surface area (ie, sum of all target ulcer surface areas) and longest duration of any individual target ulcer(s) present. The Randomized Treatment Period was considered the continuous 12 weeks of voxelotor and SOC, or placebo and SOC treatment from date of randomization (first dose, Day 1). The target leg ulcer(s) was/were assessed by visual inspection and surface area measurement(s) using digital photography at scheduled visits every 2 weeks during the 12-week Randomized. Treatment Period. Target ulcer resolution was defined as skin re-epithelialization confirmed at 2 consecutive study visits 2 weeks apart. To qualify as an event, ulcer re-epithelialization that was first assessed at Week 12 must be confirmed at Week 14. Participants demonstrating initial ulcer re-epithelialization at Week 12 continued treatment in their assigned treatment group for an additional 2 weeks to confirm ulcer resolution. At the end of the 12-week Randomized Treatment Period, all participants (with the exception of those demonstrating initial ulcer re-epithelialization at Week 12) received open-label voxelotor 1500 mg once a day (QD) and SOC for a minimum 12 weeks and target ulcer(s) that had failed to heal during the initial 12 weeks was/were followed for delayed healing.Participants who had completed 12 weeks in the Open-Label Treatment Period might continue to receive voxelotor as long as they continued to receive clinical benefit that outweighed risk as determined by the investigator or until the participant had access to voxelotor from an alternative source not associated with this protocol (eg, through a clinical Open-Label Extension [OLE] study sponsored by Pfizer, commercialization of the product, or a managed access program). Participants who planned not to continue to receive voxelotor from an alternative source continued to the follow-up period after completing 12 weeks in the Open-Label Treatment Period. This report provides full data of efficacy and safety for all the treated participants at the end of study, ie, last participant last visit (LPLV).</p>\n<p>\n Number of Participants (planned and analyzed): Approximately 80 participants were planned and a total of 88 participants were randomized and treated. Two analysis sets were predefined for the study: intent-to-treat (ITT) population, which included all randomized participants; and safety-evaluable population, which included all randomized participants who received at least one dose of study intervention. All of the 88 randomized participants were treated and thus included in both the ITT and safety-evaluable populations.</p>\n<p>\n Study Intervention:</p>\n<p>\n During the Randomized Treatment Period, participants were randomized in a 1:1 ratio to receive voxelotor 1500 mg QD (500 mg ×3 tablets) or matching placebo orally administered for 12 weeks. During the Open-Label Treatment Period, all participants received voxelotor 1500 mg QD (500 mg ×3 tablets) for a minimum of 12 weeks. In this study, all participants received the SOC per protocol for SCD leg ulcers during the Run-in, Randomized Treatment,and Open-Label Treatment periods.</p>\n<p>\n Global Interruptions and Re-starts On 10 May 2024, the administration of the study intervention, voxelotor, was voluntarily paused by Pfizer (the sponsor) due to the overall number of fatal events observed in the studywhich required further assessment of accrued data. On 25 September 2024, voxelotor was voluntarily withdrawn by Pfizer from all markets inwhich it was approved, and all ongoing voxelotor clinical studies and early access and compassionate use programs have been discontinued.</p>\n<p>\n SUMMARY OF RESULTS: Participant Disposition Of the 206 participants screened, 88 were randomized and treated, including 43 in the placebo group and 45 in the voxelotor group. Of these participants, 79 (89.8%) were in Africa (62 [70.5%] in Kenya and 17 [19.3%] in Nigeria), and 9 (10.2%) were in Latin America (all in Brazil). Out of 88 participants, 2 discontinued the study intervention during the Randomized Treatment Period, both in the voxelotor group, 1 due to AE, and the other due to withdrawal by participant. After the Randomized Treatment Period, 86 out of 88 participants entered the Open-Label Treatment Period. Of the 86 participants, 43 originally randomized to the placebo group received voxelotor (referred to “delayed voxelotor” hereafter), and 43 originally randomized to the voxelotor group continued voxelotor treatment. During the Open-Label Treatment Extension Period (including the Open-Label Treatment Period and the Follow-up Period), 75 (87.2%) participants discontinued study intervention (37 in the delayed voxelotor group and 38 in the voxelotor group), among whom the majority [59 (68.6%) participants] were discontinued due to study termination, and a total of 10 (11.6%) participants discontinued due to AEs (4 in the delayed voxelotor group and 6 in the voxelotor group).</p>\n
      • implication_results<p>\n <strong><em>“There are no changes proposed to the current practice for the treatment of leg ulcers in patients with sickle cell disease at this time.”</em></strong></p>\n<p>\n  </p>\n<p>\n  </p>\n
      • quantity_imported537
      • quantity_dispensed229
      • quantity_destroyed308
      • quantity_exported0
      • balance_site0
      • final_date2025-10-24 11:54:15
      • modified2025-10-24 11:54:15
      • created2021-09-17 12:14:48
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id735
        • application_id1068
        • given_nameVidelis
        • middle_name
        • family_nameNduba
        • qualificationMBcHB, MPH, PhD
        • professional_addressKEMRI/CRDR Kenyatta National Hospital Off Hospital Road P.O Box 47855-00100 Nairobi-Kenya
        • telephone+254790484654
        • emailVNduba@kemri.org
        • created2021-09-17 12:21:45
        • modified2022-02-24 10:25:42
    • SiteDetail(array)
      • 0(array)
        • id1135
        • application_id1068
        • county_id41
        • site_nameKEMRI/CRDR Siaya Clinical Research Annex
        • physical_addressSiaya County Hospital
        • contact_details+254790484654
        • contact_personDr Videlis Nduba
        • site_capacity(null)
        • misc(null)
        • created2021-09-17 12:21:45
        • modified2022-02-24 10:25:42
        • County(array)
          • id41
          • county_nameSiaya
          • created2012-06-15 10:26:56
          • modified2012-06-15 10:26:56
      • 1(array)
        • id1155
        • application_id1068
        • county_id47
        • site_nameKEMRI CRDR Clinical Research Clinic Nairobi
        • physical_address Off Hospital Road P.O Box 47855-00100 Nairobi-Kenya
        • contact_details+254790484654
        • contact_personDr Videlis Nduba
        • site_capacity(null)
        • misc(null)
        • created2021-10-29 15:15:22
        • modified2022-02-24 10:25:42
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
    • Sponsor(array)
      • 0(array)
        • id542
        • application_id1068
        • sponsorGlobal Blood Therapeutics, Inc. 181 Oyster Point Blvd. South San Francisco, CA 94080 United States
        • sponsor_typeResearch Institution
        • contact_personCarolyn Hoppe, MD, Senior Medical Director
        • addressGlobal Blood Therapeutics, Inc. 181 Oyster Point Blvd South San Francisco, CA 94080 United States of America
        • telephone_number(650) 741-7741
        • fax_number
        • cell_number(650) 741-7741
        • email_addresschoppe@gbt.com
        • created2021-09-17 12:21:45
        • modified2022-02-24 10:25:42
  • 4(array)
    • Application(array)
      • id1368
      • user_id692
      • trial_status_id1
      • abstract_of_study<p style=\"margin-left: 18pt;\">\n <span style=\"font-size:16px;\">The 2021 revised Center for Disease and Control (CDC) sexually transmitted infection (STI) treatment guidelines recommend doxycycline as the preferred treatment for chlamydia trachomatis (CT) in most populations. The extent to which this recommendation will be translated into practice remains to be seen since many clinicians prefer to use azithromycin due to the relative ease of a single dose treatment. The rationale for studying a 3-day course (100 mg oral twice daily) as an alternate treatment is that this length of therapy is likely to provide sufficient treatment based on what is known about the life cycle of CT and pharmacokinetics (PK) of doxycycline, as well as preliminary clinical data. The CT life cycle is 48-72 hours, and the serum half-life of doxycycline is 18-22 hours. Thus, a 3-day course (72 hours) should provide sufficient coverage to eliminate CT. A small RCT compared the 3-day versus 7- day course of doxycycline for CT (N=73) in women with chlamydial cervicitis in the mid-1990s (Reedy et al., 1997). In that study, the proportion of women who cleared their chlamydial infection was nearly identical among women randomized to 3-day (94.3% cure) versus 7-day (94.7% cure) doxycycline.</span></p>\n<p style=\"margin-left: 18pt;\">\n <span style=\"font-size:16px;\">This is a non-inferiority study design, which is a study that tests whether a new treatment is no worse than the standard-of-care treatment to which it is being compared. In this study we will test whether a shorter course of treatment for CT (100 mg doxycycline twice daily for 3 days) is no worse than the current standard-of-care (100 mg doxycycline twice daily for 7 days). Participants randomized to 3-days of doxycycline will receive 4 days of placebo pills (the medication will be labeled so that participants will take the active medication on days 1-3 and placebo on days 4-7). Placebo pills will be included for this arm so that participants are blinded to the arm to which they were randomized, thereby minimizing the likelihood that participants randomized to the 3-day arm will systematically resume sexual activity sooner than those randomized to the 7-day arm. There is no arm that will receive only placebo since a safe and effective treatment for CT already exists.</span></p>\n<p style=\"margin-left: 18pt;\">\n <span style=\"font-size:16px;\">This study will examine the non-inferiority of a 3-day regimen of doxycycline compared to the recommended 7-day regimen. If this shorter regimen is found to be non-inferior to the standard 7-day regimen, it is anticipated that uptake of doxycycline for CT treatment will become more widespread, leading to better individual and public health outcomes compared to widespread use of azithromycin at a lower cost with more judicious antibiotic use than a 7-day doxycycline regimen.</span></p>\n<p>\n  </p>\n
      • study_title<p>\n A Phase 4 Study of a 3-Day Vs. 7-Day Regimen of Doxycycline for the Treatment of Chlamydial Infection.</p>\n
      • laymans_summary<p style=\"margin-left:18.0pt;\">\n <span style=\"font-size:16px;\">Chlamydia trachomatis is a common infection that can be contracted through sexual activity. Doctors typically use a medication called doxycycline to treat it, but some prefer azithromycin because it's easier to take. The aim of this study is to investigate whether a shorter duration of doxycycline treatment (3 days) is just as effective as the longer duration (7 days). If this shorter duration of treatment is found to be as effective as the standard 7-day treatment, it is anticipated that uptake of doxycycline for treatment of chlamydia will become more widespread. This will lead to better individual and public health outcomes compared to the current widespread use of azithromycin at a lower cost with more judicious antibiotic use than a 7-day doxycycline treatment duration.</span></p>\n<p style=\"margin-left:18.0pt;\">\n <span style=\"font-size:16px;\">The study will take place in the United States and Kenya and approximately 664 participants will take part in the study across these different locations. The study will recruit potential participants utilizing in-person outreach by staff members in our Community Section, which handles recruitment and retention activities for the Pwani Research Centre.  Community Section staff will conduct recruitment activities in collaboration with our Community Advisory Board. Potential participants will be invited to the site for consenting purposes. Once informed consent is obtained, participants’ demographic data will be collected. Visit procedures such as medical history, physical exams, laboratory samples (urine, vaginal and rectal swabs) will be collected. Thereafter, those who qualify to join the study will be randomly assigned to either the short course treatment or the longer course treatment. Participants will be followed up for one month. Those who will receive the 3-day treatment will also get placebo pills for 4 days, allowing blinding of both participants and investigators to the treatment arm. Participants who are eligible take part in the study will be required to adhere to all visit procedures and visit schedules if they wish to participate. Those who are not eligible will end the study at that point.</span></p>\n<p style=\"margin-left:18.0pt;\">\n <span style=\"font-size:16px;\">This study may bring about minor inconvenience or discomfort for participants. Collecting samples might cause temporary discomfort, and asking about sexual history might induce mild stress. Participating might involve sacrificing some privacy, but the study team will prioritize keeping information confidential. Participants' personal information that may identify them won't be disclosed in any study reports, documents, or to unauthorized personnel. If the 3-day treatment turns out to be less effective than the 7-day treatment, individuals in the 3-day group might still have some remaining infection that could worsen. However, the study team will closely monitor this possibility and provide the standard of care treatment (7 days longer course treatment) in the event of treatment failure.</span></p>\n<p style=\"margin-left:18.0pt;\">\n <span style=\"font-size:16px;\">Participants may receive additional medical care and tests as part of the study including extra checks for symptoms and counseling on risk reduction for acquisition and transmission of sexually transmitted infections (STIs) and HIV. This study will contribute to our understanding of better ways to treat this infection and use antibiotics wisely, benefiting society as a whole.</span></p>\n<p style=\"margin-left:18.0pt;\">\n <span style=\"font-size:16px;\">The study was expected to begin in late 2023, with each participant involved for about 29 days. The entire study will take around 25 months. Currently we expect to start the study in March 2024.</span></p>\n<p>\n  </p>\n
      • short_titleDoxy Short Course
      • protocol_noECCT/24/01/03
      • version_no2.0
      • date_of_protocol21-08-2023
      • study_drugDoxycycline hyclate
      • disease_conditionChlamydia
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical1
      • product_type_medical_device0
      • product_type_chemical_nameDoxycycline hyclate
      • product_type_medical_device_name
      • comparatorYes
      • comparator_nameDoxycycline hyclate
      • comparator_registeredYes
      • comparator_countriesKenya, USA
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressfrao@uw.edu
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter0
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
      • applicant_prev_data1
      • applicant_stability_data1
      • applicant_analysis_cert1
      • applicant_pictorial_sample1
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      • declaration_applicantJackson Nyangaresi Nyandoro
      • declaration_date119-01-2024
      • declaration_principal_investigatorRaymond Scott McClelland
      • declaration_date219-01-2024
      • placebo_presentYes
      • study_objectives<p>\n <span style=\"font-size:16px;\">1. To compare the efficacy of a 3-day vs. 7-day regimen of doxycycline for treatment of urogenital CT infection in persons AFAB based on microbiologic cure .</span></p>\n<p>\n <span style=\"font-size:16px;\">2. To compare the efficacy of a 3-day vs. 7-day regimen of doxycycline for treatment of rectal CT infection in persons AMAB based on microbiologic cure.</span></p>\n<p>\n <span style=\"font-size:16px;\">3.To compare the efficacy of a 3-day vs. 7-day regimen of doxycycline for treatment of rectal CT infection in persons AFAB based on microbiologic cure. To compare the efficacy of a 3-day vs. 7-day regimen of doxycycline for treatment of urethral CT infection in persons AMAB based on microbiologic cure. </span></p>\n<div>\n <span style=\"font-size:16px;\">4. To compare the efficacy of a 3-day vs. 7-day regimen of doxycycline for treatment of total CT infection (any anatomic site) in persons AFAB based on microbiologic cure. </span></div>\n<div>\n <span style=\"font-size:16px;\">5. To compare the efficacy of a 3-day vs. 7-day regimen of doxycycline for treatment of total CT infection (any anatomic site) in persons AMAB based on microbiologic cure.</span></div>\n<div>\n <span style=\"font-size:16px;\">6. To compare the efficacy of a 3-day vs. 7-day regimen of doxycycline for treatment of rectal CT infection in persons AMAB based on microbiologic cure, stratified by lymphogranuloma venereum (LGV) status.</span></div>\n<div>\n <span style=\"font-size:16px;\">7. Exploratory- Among those with a CT-positive NAAT at day 29, determine whether CT present at follow-up is the same as enrollment infection.</span></div>\n<div>\n  </div>\n<p>\n  </p>\n
      • principal_inclusion_criteria<div>\n <span style=\"font-size:16px;\">1.<span style=\"white-space:pre\"> </span>Has untreated urogenital CT (in persons AFAB) or rectal CT (in persons AMAB), with a positive NAAT result or point-of care test result within 14 days. Point-of-care test may or may not be FDA-cleared for CLIA waiver for diagnosis depending upon anatomic site of infection.</span></div>\n<div>\n <span style=\"font-size:16px;\">2.<span style=\"white-space:pre\"> </span>Must be age ≥16 years (where the IRB permits individuals aged 16-17 years old to consent to research); otherwise age > 18 years.</span></div>\n<div>\n <span style=\"font-size:16px;\">3.<span style=\"white-space:pre\"> </span>Willing and able to understand and provide written informed consent before initiation of any study procedures.</span></div>\n<div>\n <span style=\"font-size:16px;\">4.<span style=\"white-space:pre\"> </span>Willing to complete a 7-day study drug regimen.</span></div>\n<div>\n <span style=\"font-size:16px;\">5.<span style=\"white-space:pre\"> </span>Willing to abstain from condom-less anal or vaginal sex during the trial</span></div>\n<div>\n <span style=\"font-size:16px;\">6.<span style=\"white-space:pre\"> </span>Willing and able to adhere to planned study procedures for all study visits</span></div>\n<div>\n <span style=\"font-size:16px;\">7.<span style=\"white-space:pre\"> </span>Has valid contact information.</span></div>\n<div>\n  </div>\n
      • principal_exclusion_criteria<div>\n <span style=\"font-size:16px;\">1.<span style=\"white-space:pre\"> </span>For persons AFAB: lower abdominal or pelvic pain or other signs or symptoms consistent with a clinical diagnosis of pelvic inflammatory disease (PID). </span></div>\n<div>\n <span style=\"font-size:16px;\">2.<span style=\"white-space:pre\"> </span>Signs and symptoms that, in the judgement of a qualified clinician, warrant a prolonged course of treatment with doxycycline.</span></div>\n<div>\n <span style=\"font-size:16px;\">3.<span style=\"white-space:pre\"> </span>Received antimicrobial therapy active against C. trachomatis within 21 days prior to positive CT test result, or between the positive CT test result and study enrollment.</span></div>\n<div>\n <span style=\"font-size:16px;\">4.<span style=\"white-space:pre\"> </span>Planning to take antimicrobial therapy active against CT during the study period (e.g. doxycycline post-exposure prophylaxis, treatment for mycoplasma genitalium infection, acne, or any other non-STI medical condition).</span></div>\n<div>\n <span style=\"font-size:16px;\">5.<span style=\"white-space:pre\"> </span>Currently enrolled in or plan to enroll in another study using antimicrobial therapy active against C. trachomatis during the study period.</span></div>\n<div>\n <span style=\"font-size:16px;\">6.<span style=\"white-space:pre\"> </span>Pregnant or lactating, or plan to become pregnant within the study period.</span></div>\n<div>\n <span style=\"font-size:16px;\">7.<span style=\"white-space:pre\"> </span>Known moderate to severe allergy to tetracyclines, excluding tetracycline-induced photosensitivity.</span></div>\n<div>\n <span style=\"font-size:16px;\">8.<span style=\"white-space:pre\"> </span>Plan to move or travel to another location that would preclude study follow-up appointments in clinic in the next 30 days.</span></div>\n<div>\n <span style=\"font-size:16px;\">9.<span style=\"white-space:pre\"> </span>Use of a medication contraindicated to treatment with doxycycline within 7 days prior to enrollment or during the study period (systemic retinoids, barbiturates, carbamazepine, phenytoin, warfarin).</span></div>\n<div>\n <span style=\"font-size:16px;\">10.<span style=\"white-space:pre\"> </span>Previous enrollment in this trial.</span></div>\n<div>\n <span style=\"font-size:16px;\">11.<span style=\"white-space:pre\"> </span>Any condition that, in the judgment of the investigator, precludes participation because it could affect participant safety or determination of study endpoints.</span></div>\n<div>\n  </div>\n
      • primary_end_points<div>\n <span style=\"font-size:16px;\">1. Proportion of participants with negative NAAT of vaginal swab at Day 29 and without positive NAAT of vaginal swab between treatment and Day 29.</span></div>\n<div>\n <span style=\"font-size:16px;\">2. Proportion of participants with negative NAAT of rectal swab at Day 29 and without positive NAAT of rectal swab between treatment and Day 29.</span></div>\n<div>\n  </div>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety0
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
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      • trial_human_pharmacology0
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      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<div>\n <span style=\"font-size:16px;\">This study will be conducted at the Pwani Research Centre, located at the Ganjoni Dispensary in Mombasa County. Ganjoni Dispensary is on  Mnazi Mmoja Road, Opposite Mombasa Sports Club. The site is affiliated with the University of Washington and the University of Nairobi. Office space at Pwani Research Centre includes offices in the main clinic building and in the new Ndinya-Achola Research Building, constructed in 2012. There are 5 offices, which house the research, clinical, and administrative staff, in addition to separate dedicated server and printer rooms. There are also two large meeting rooms available for training: the boardroom (seats up to 30) and seminar room (seats up to 60). Both are internet connected and include equipment for teleconferencing. The main dispensary and the new building are connected to an 80KVA diesel generator for backup power supply. </span></div>\n<div>\n <span style=\"font-size:16px;\">Research infrastructure at the site includes both clinical space in the main dispensary building and dedicated research spaces in the new Ndinya-Achola Research Building. There are 6 fully equipped research examination rooms including an emergency room and five consenting/interview/counselling/nursing assessment rooms are available. The emergency room is equipped with a defibrillator, oxygen cylinder, double crank hospital bed and a modern crash cart that includes medications for use in emergency resuscitation. One of the research examination rooms is equipped for colposcopy, biopsies, and cryotherapy. There are indoor and outdoor patient waiting areas at the dispensary. </span></div>\n<div>\n <span style=\"font-size:16px;\">Several non-clinical spaces also support research. The Ndinya-Achola building has a clinical trials pharmacy that is air conditioned and has continuous temperature monitoring with an alert system that contacts a staff member in Mombasa if the temperature is out of range. A small onsite laboratory performs Gram staining, microscopy, chemistries, HIV testing, PSA detection, and urine pregnancy testing. This laboratory has a centrifuge, -80ºC freezer, and 2-8ºC refrigeration space needed for sample processing and storage. </span></div>\n<div>\n <span style=\"font-size:16px;\">Our main Research Laboratory at the Coast General Teaching and Referral Hospital, Mombasa, was established in 1995, and has come to serve as a reference research laboratory for groups throughout the East Africa region. The laboratory performs HIV-1 ELISA, HSV-2 ELISA, CD4 lymphocyte counts, cultures for Neisseria gonorrhoeae, Haemophilus ducreyi (chancroid), Trichomonas vaginalis, and Lactobacillus; Hologic Aptima nucleic acid amplification assays for Neisseria gonorrhoeae, Chlamydia trachomatis, Mycoplasma genitalium, Trichomonas vaginalis, high-risk Human Papilloma Virus detection, Hepatitis C Viral Load monitoring, and HIV viral load monitoring; Gram stain and wet mount microscopy; cryopreservation and storage of samples in both -80ºC freezers and liquid nitrogen tanks. Sample inventories are maintained in a Freezerworks sample tracking, biorepository, and freezer inventory program (Dataworks Development, Mountlake Terrace, WA). While our access to the County power supply is generally excellent, the laboratory has a 120 KVA diesel generator with automatic switch-over which provides power backup even when staff are not on site. Our -80ºC freezers also have liquid CO2 backup. The laboratory is registered with the Kenya Medical Laboratory Technicians and Technologists Board.</span></div>\n<div>\n  </div>\n<div>\n <span style=\"font-size:16px;\">Attached in the notification section is the comprehensive staff list for the Pwani Research Centre and the KEMRI CCR-PHRD site detailed description.</span></div>\n<div>\n  </div>\n
      • other_details_explanation<p>\n <span style=\"font-size:16px;\">Chlamydia trachomatis (CT) is the most common STI in the world. Sub-Saharan Africa has the highest age-standardized CT incidence in the world, as well as an alarmingly high prevalence among adolescent girls and young women, including a CT prevalence of 16% among young Kenyan women who reported only one lifetime sex partner (Yuh et al., 2020).</span></p>\n<p>\n <span style=\"font-size: 16px;\">In the United States (US), there were an estimated 4 million cases of CT in 2018 (Kreisel et al., 2021). Despite longstanding public health chlamydia control programs in the US, rates of reported chlamydia have persistently increased over the past 20 years and are now at an all-time high. Chlamydial infections disproportionately impact young women (<25 years of age), particularly Black, Hispanic, and Native American women, and men who have sex with men (MSM).</span></p>\n<div>\n <span style=\"font-size: 16px;\">Additionally, in </span><span style=\"font-size: 16px;\">the U.S., bacterial STIs disproportionately impact people who are members of racial and ethnic </span><span style=\"font-size: 16px;\">minority groups, particularly Black, American Indian/Alaska Native, and Hispanic/Latino </span><span style=\"font-size: 16px;\">persons. This disparity reflects the impact of long-standing social and structural factors in U.S. </span><span style=\"font-size: 16px;\">society, not a difference in individual sexual behavior.</span></div>\n<div>\n <span style=\"font-size: 16px;\">We will strive to recruit a study </span><span style=\"font-size: 16px;\">population that reflects the epidemiology of CT infections. </span></div>\n<div>\n  </div>\n<div>\n <span style=\"font-size: 16px;\">At U.S. sites, we will make specific </span><span style=\"font-size: 16px;\">recruitment efforts to ensure inclusion and representation of racial/ethnic minorities and </span><span style=\"font-size: 16px;\">transgender/gender diverse persons and monitor the demographics of enrolled participants </span><span style=\"font-size: 16px;\">throughout the study.</span></div>\n<div>\n  </div>\n<div>\n <span style=\"font-size: 16px;\">In non-US/Kenyan sites, we anticipate recruiting a population that is </span><span style=\"font-size: 16px;\">representative of the diverse tribes and ethnicities in these locations.</span></div>\n<div>\n  </div>\n<div>\n <span style=\"font-size:16px;\">Based on this data this trial will generate information that will provide guidance on treatment of chlamydial infections in these countries and beyond.</span></div>\n
      • other_details_regulatory_notapproved<p>\n <span style=\"font-size:16px;\">N/A</span></p>\n
      • other_details_regulatory_approved<p>\n <span style=\"font-size:16px;\">None</span></p>\n
      • other_details_regulatory_rejected<p>\n <span style=\"font-size:16px;\">N/A</span></p>\n
      • other_details_regulatory_halted<p>\n <span style=\"font-size:16px;\">N/A</span></p>\n
      • estimated_duration25 Months
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparator7-day Doxycycline hyclate
      • design_controlled_other_medicinalNo
      • design_controlled_placeboYes
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
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      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states2
      • number_of_sites2
      • multi_country_listKenya, USA
      • data_monitoring_committeeYes
      • total_enrolment_per_site150
      • total_participants_worldwide664
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsNo
      • subjects_vulnerable_populationsNo
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameRaymond
      • investigator1_middle_nameScott
      • investigator1_family_nameMcClelland
      • investigator1_qualificationMD, MPH
      • investigator1_professional_addressGanjoni Dispensary on Mnazi Mmoja Road, opposite the Mombasa Sports Club Box 91276 – 80103, Mombasa, Kenya
      • investigator1_telephone+254733-975453
      • investigator1_emailmcclell@uw.edu
      • organisations_transferred_Yes
      • number_participants300
      • notification
      • approval_date18-06-2024
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted19-01-2024
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewer comments have been addressed adequately.
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      • quantity_imported(null)
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      • balance_site(null)
      • final_date(null)
      • modified2025-10-01 09:13:26
      • created2024-01-15 16:51:48
      • total_sites(null)
      • ecitizen_invoice(null)
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        • family_nameNyandoro
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        • professional_addressGanjoni Dispensary on Mnazi Mmoja Road, opposite the Mombasa Sports Club Box 91276 – 80103, Mombasa, Kenya
        • telephone+254733-975453
        • emailjcksn22@uw.edu
        • created2024-01-16 09:23:38
        • modified2024-01-19 17:19:15
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        • middle_nameRwamba
        • family_nameMugo
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        • professional_addressKenya Medical Research Institute (KEMRI) P.O. Box 54840 00200, Off Raila Odinga Way, Nairobi, Kenya
        • telephone+254733 629665
        • emailrwamba@uw.edu
        • created2024-01-16 10:02:12
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        • physical_addressGanjoni Dispensary on Mnazi Mmoja Road, opposite the Mombasa Sports Club
        • contact_details Box 91276 – 80103, Mombasa, Kenya
        • contact_personJackson Nyangaresi Nyandoro
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          • created2012-05-31 16:15:11
          • modified2012-07-09 13:06:23
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        • application_id1368
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        • site_nameKEMRI CCR-PHRD
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          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
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        • id719
        • application_id1368
        • sponsorNIAID(Division of Microbiology and Infectious Diseases)
        • sponsor_typeOthers
        • contact_personMelinda Tibbals
        • addressNIAID Office of Communications and Government Relations 5601 Fishers Lane, MSC 9806 Bethesda, MD 20892-9806 (deliveries: Rockville, MD 20852) United States of America
        • telephone_number+12406273387
        • fax_number
        • cell_number+12406273387
        • email_addressmelinda.tibbals@nih.gov
        • created2024-01-16 09:23:38
        • modified2024-01-19 17:19:15
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      • 2Media/Lib/mm/src/Mime/Type/Magic/Adapter.php
      • 3Media/Lib/mm/src/Mime/Type/Glob/Adapter/Memory.php
      • 4Media/Lib/mm/src/Mime/Type/Glob/Adapter.php
      • 5Media/Lib/mm/src/Media/Process.php
      • 6Media/Lib/mm/src/Media/Info.php
  • Search(array)
    • Component(array)
      • 0Search/Controller/Component/PrgComponent.php
    • Behavior(array)
      • 0Search/Model/Behavior/SearchableBehavior.php
  • Shim(array)
    • Config(array)
      • 0Shim/Config/bootstrap.php
  • Tools(array)
    • Config(array)
      • 0Tools/Config/bootstrap.php