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• applications(array)
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    • Application(array)
      • id956
      • user_id81
      • trial_status_id7
      • abstract_of_study<ol>\n <li>\n <strong>ABSTRACT</strong></li>\n</ol>\n<p>\n Meningococcal disease and gonorrhoea are caused by bacteria that are closely related but cause different diseases that are spread in different ways. New evidence suggests that the Meningococcal B vaccine (Bexsero®) licensed outside of Kenya against meningococcal B disease may also be effective against gonorrhoea due to genetic similarities between the two organisms causing the two diseases. We will conduct a clinical trial of the Meningococcal B vaccine (Bexsero®) in approximately 50 male and female participants aged 18-25 years who are in follow up in KEMRI cohorts  (including HIV-uninfected and infected individuals) at the KEMRI clinic in Mtwapa. This is not an efficacy trial. Instead, we will assess if immunisation of individuals at risk for gonococcal infection with 4CMenB (Bexsero®) elicits humoral and T cell cross-reactive responses against Neisseria gonorrhoeae (Ng). Participants will make five study visits, including a screening visit, an enrolment visit and 3 follow up visits. We will offer vaccination with the Meningococcal B vaccine (Bexsero®) vaccine at the enrolment visit and approximately 2 months later. We will collect a 20ml blood sample at enrolment, and a 70ml blood sample following the second vaccination. At study completion (month 6), we will collect a 4ml blood sample.  We will collect a throat swab, a urine sample (for men), vaginal swab, and an anal swab at the enrolment, month 3 and month 6 visit to test for Chlamydiae and Gonorrhoea infection. Total study participation for participants is 6 months. Upon study completion, participants will continue to receive research care at the KEMRI clinic in Mtwapa.</p>\n
      • study_title<p>\n <strong>Protocol Title: </strong>USE OF BEXSERO IMMUNIZATION TO DETECT CROSS REACTIVE ANTIGENS AND ANTI-GONOCOCCAL ANTIBODIES IN KEY POPULATIONS IN KENYA.</p>\n
      • laymans_summary<p style=\"margin-left:18.0pt;\">\n <strong>What is the problem/background?</strong> Gonorrhoea is a <a href=\"https://www.cdc.gov/std/default.htm#WhatAreSTDs\">sexually transmitted infection</a> that can infect both men and women. It can cause infections in the genitals, rectum, and throat. It is a very common infection, especially among young people aged 18-25 years.</p>\n<p style=\"margin-left:18.0pt;\">\n Meningococcal disease and gonorrhoea are caused by bacteria that are closely related but cause different diseases that are spread in different ways. New evidence suggests that the Meningococcal B vaccine (Bexsero®) licensed outside of Kenya against meningococcal B disease may also be effective against gonorrhoea due to genetic similarities between the two organisms causing the two diseases. The aim of this study is to generate data to develop a gonorrhoea vaccine, using an existing vaccine against meningococcal disease.</p>\n<p style=\"margin-left:18.0pt;\">\n  </p>\n<p style=\"margin-left:18.0pt;\">\n <strong>What questions are we trying to answer?</strong></p>\n<p style=\"margin-left:18.0pt;\">\n To assess if immunisation of individuals at risk for gonococcal infection with 4CMenB (Bexsero®) will enhance an immune response against <em>Neisseria gonorrhoeae</em>.</p>\n<p>\n  </p>\n<p style=\"margin-left:18.0pt;\">\n <strong>Where is the study taking place, how many people does it involve and how are they selected?</strong></p>\n<p style=\"margin-left:18.0pt;\">\n Approximately 50, young adults (aged 18 - 25 years old) who are enrolled in the KEMRI cohort studies (known as Open B, Three-site, N, or Sue; including HIV-uninfected and infected individuals) in the KEMRI clinic in Mtwapa will be able to participate in this study.</p>\n<p style=\"margin-left:18.0pt;\">\n  </p>\n<p style=\"margin-left:18.0pt;\">\n <strong>What does the study involve for those who are in it?</strong></p>\n<p style=\"margin-left:18.0pt;\">\n Participants will make five study visits, including a screening visit, an enrolment visit and 3 follow up visits. We will offer vaccination with the Meningococcal B vaccine (Bexsero®) vaccine at the enrolment visit and approximately 2 months later. We will use socio-demographic and risk behavior data collected under the KEMRI cohort studies. We will collect a 24 ml blood sample (2 ½ table spoons) at enrolment, and a 70 ml blood sample (7 table spoons) following the second vaccination. At study completion (month 6), we will collect a 4ml (1 tea spoon) blood sample.  We will collect a throat swab, a urine sample (for men), vaginal swab, and an anal swab at the enrolment, month 3 and month 6 visit to test for Chlamydiae and Gonorrhoea infection.</p>\n<p style=\"margin-left:18.0pt;\">\n <strong>What are the benefits and risks/costs of the study for those involved?</strong>  In this study, the Meningococcal B vaccine (Bexsero®) is safe and is well tolerated, with over 17 million doses already given worldwide. There is the possibility of common side effects that are mild and may include a mild fever, soreness at the injection site, headache and generally feeling unwell for 1-2 days, similar to some other vaccines. As with all vaccines there is the possibility of rare and more serious reactions such as an allergic/ anaphylactic reaction to the vaccine.</p>\n<p style=\"margin-left:18.0pt;\">\n  </p>\n<p style=\"margin-left:18.0pt;\">\n For participants there are no direct benefits, as they will receive the same research services as in the KEMRI cohorts that they participate in already. Meningococcal B vaccine (Bexsero®) prevents only against the meningococcal B strain which is common in Europe, Australia, and the Unites States.</p>\n<p style=\"margin-left:18.0pt;\">\n  </p>\n<p style=\"margin-left:18.0pt;\">\n <strong>How will the study benefit society?</strong>  Researchers hope to gain new insights on how the Meningococcal B vaccine (Bexsero®) can be improved upon to make a vaccine against gonorrhoeae. There is currently no vaccine available against <em>N. gonorrhoeae</em>.</p>\n<p style=\"margin-left:18.0pt;\">\n   </p>\n<p style=\"margin-left:18.0pt;\">\n <strong>When does the study start and finish?</strong></p>\n<p>\n This study is anticipated to start in the fourth quarter of 2020, following ethical and regulatory approvals. Participants will be involved in the study for 6 months. The sample and data analysis will continue for 1-2 years and a report will be disseminated in 2022.</p>\n
      • short_titleGC vaccine study in kenya
      • protocol_noECCT/20/11/01
      • version_noVersion 1.3 dated 21 May 2020
      • date_of_protocol21-07-2020
      • study_drug4CMenB (Bexsero®)
      • disease_conditionNeisseria gonorrhoeae.
      • product_type_biologicals1
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines1
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device0
      • product_type_chemical_name
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressCGMRCCSC@kemri-wellcome.org
      • 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_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
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      • 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_applicantAlexander Ndung\'u - Clinician
      • declaration_date103-11-2020
      • declaration_principal_investigatorDr Eduard Sanders -P.I
      • declaration_date203-11-2020
      • placebo_presentNo
      • study_objectives<p style=\"margin-left:18.0pt;\">\n To assess if immunisation of individuals at risk for gonococcal infection with 4CMenB (Bexsero®) will enhance an immune response against <em>Neisseria gonorrhoeae</em>.</p>\n<p>\n <strong>Primary objective</strong><strong> –</strong>To assess if immunisation of individuals at risk for gonococcal infection with 4CMenB (Bexsero) elicits humoral and T cell cross-reactive responses against Ng.</p>\n<p>\n <strong>Explorative objective – </strong>To assess if immunisation of individuals at risk for gonococcal infection with 4CMenB (Bexsero) differs between HIV negative and positive participants.</p>\n<p>\n We will exploit Bexsero as an immunological probe to identify antigens that elicit humoral cross-reactive responses against Ng. We will examine IgG reactivity against these Ng proteins in microarrays with sera from Bexsero vaccinated individuals with high Ng exposure.</p>\n<p>\n Comparison of the pre/post immunization sera will provide a comprehensive overview of Bexsero antigens which induce Ng-cross reactive IgG responses and could therefore be responsible for Nm OMV-mediated protection against Ng. This approach is likely to be more informative than comparing results between control and immunized subjects, as individuals’ exposure and responses to Ng are likely to differ. We will also explore if immune responses differ between HIV-negative and positive participants. Screening will be performed on plasma taken at enrolment, approximately 2 weeks post first immunization, approximately 2 weeks post second immunization and at 6 months.</p>\n
      • principal_inclusion_criteria<ol>\n <li value=\"1.1\">\n <strong>Inclusion criteria</strong></li>\n</ol>\n<ul>\n <li>\n Healthy male and female as assessed by a medical history, physical exam, and laboratory tests. HIV-positive participants who are adherent to ART and virally suppressed (viral load <200 copies per ml) are considered healthy .</li>\n <li>\n At least 18 years of age on the day of screening and will not reach 26th birthday on the day of the second vaccination (approximately 6 weeks after enrolment)</li>\n <li>\n Willing and able to give informed consent for participation in the trial before any study-related procedures are performed.</li>\n <li>\n Willing to donate blood samples for immunogenicity assessments.</li>\n</ul>\n
      • principal_exclusion_criteria<ol>\n <li value=\"1.1\">\n <strong>Exclusion criteria</strong></li>\n</ol>\n<ul>\n <li>\n Any clinically significant acute or chronic medical condition that is considered progressive that, in the opinion of the Principal Investigator or designee, makes the volunteer unsuitable for participation in the trial</li>\n <li>\n Pregnancy</li>\n <li>\n Participation in another clinical trial (i.e. investigational HIV vaccine candidate), within the previous 3 months or expected participation during the study</li>\n <li>\n Bleeding disorder diagnosed by a physician (e.g., factor deficiency, coagulopathy or platelet disorder that requires special precautions).</li>\n <li>\n History of severe local or systemic reactogenicity to vaccines (e.g., anaphylaxis, respiratory difficulty, angioedema)</li>\n</ul>\n
      • primary_end_points<p>\n <strong>Identify <em>Ng </em>cross-reactive, human immune responses elicited by Bexsero</strong>®:</p>\n<p>\n We will exploit Bexsero as an immunological probe to identify antigens that elicit humoral cross-reactive responses against Ng. Our collaborators have analysed the OMV proteome of Bexsero and have constructed protein microarrays containing 91 <em>Nm </em>proteins. We will examine IgG reactivity against these Nm proteins in microarrays with sera from Bexsero vaccinated individuals with high Ng exposure at a collaborative laboratory at the University of Manchester.</p>\n<p>\n Comparison of the pre/post immunization sera will provide a comprehensive overview of Bexsero antigens which induce Ng-cross reactive IgG responses and could therefore be responsible for Nm OMV-mediated protection against Ng.  Screening will be performed on plasma taken at enrolment,  approximately 2 weeks post second immunization and at 6 months time point.  The screening will take place at three sites, KEMRI –CGMRC, the University of Oxford, and a collaborators lab at the Uniformed Services University in the USA. Antigens and/or microarrays will be sent to KEMRI-CGMRC where printing on slides and running of the microarray will be performed. Microarrays will also be done by Jeremy Derrick at University of Manchester. Samples with cross-reactive antibodies against the OMV antigens, which may offer protection against Ng will be selected to inform antigen choice and vaccine design.</p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy0
      • 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_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n Capacity of Site(s) <span class=\"sterix\">*</span></p>\n<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:208px;\">\n <p>\n <strong>Name</strong></p>\n </td>\n <td style=\"width:208px;\">\n <p>\n <strong>Designation</strong></p>\n </td>\n <td style=\"width:208px;\">\n <p>\n <strong>Qualifications </strong></p>\n </td>\n </tr>\n <tr>\n <td colspan=\"3\" style=\"width:623px;\">\n <p>\n <strong>Investigators</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n Prof Eduard Sanders</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Principal Investigator</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n MD, MPH, PhD</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n Eunice Nduati</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Research Scientist- Immunology</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n BSc, MSc, PhD</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n <strong>Clinical team^a</strong></p>\n </td>\n <td style=\"width:208px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:208px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n Dr Clara Agutu</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Medical Officer/Trial Clinician and Study Coordinator</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n MBChB, MPH, MSc</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n Fredrick Ogadah</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Clinical Officer/ Trial Clinician</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Dip</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n Alex Thion’go</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Clinical Officer/ Trial Clinician</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Dip</p>\n </td>\n </tr>\n <tr>\n <td colspan=\"3\" style=\"width:623px;\">\n <p>\n <strong>Pharmacy</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n Jimmy Shangala</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Trial Pharmacist (Pharmacist of Record)</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n BPharm</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n Mwaganyuma Mwatasa</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Trial Pharmacist</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n BPharm</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n Beatrice Wavinya</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Pharmaceutical Technologist</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Dip</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n Andrew Guantai</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Pharmaceutical Technologist</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Dip</p>\n </td>\n </tr>\n <tr>\n <td colspan=\"3\" style=\"width:623px;\">\n <p>\n <strong>Regulatory</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n Jennifer Kanungi</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Regulatory Affairs</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Dip, PG Dip</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n Esther Ndiangui</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Quality Officer</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Dip</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n <strong>Administration </strong></p>\n </td>\n <td style=\"width:208px;\">\n <p>\n  </p>\n </td>\n <td style=\"width:208px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n Lucie Ikumi</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Project Administrator</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Dip</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n Brenda Nekesa</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Administrative Assistant/Reception</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Dip</p>\n </td>\n </tr>\n <tr>\n <td colspan=\"3\" style=\"width:623px;\">\n <p>\n <strong>Community Engagement</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n Evans Gichuru</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Community Liaison Officer</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n BA</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n Dancan Otieno</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Community Facilitator</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Dip</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n Khamisi Shilingi</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Research Counselor</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Dip</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n Alex Kigoro</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Research Counselor</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Dip</p>\n </td>\n </tr>\n <tr>\n <td colspan=\"3\" style=\"width:623px;\">\n <p>\n <strong>Data Management </strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n Elizabeth Wahome</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Data Manager</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n BSc, MSc</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n Esther Yaa</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Senior Data Clerk</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Dip</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n Fanis Kiteki</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Data Clerk</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Dip</p>\n </td>\n </tr>\n <tr>\n <td colspan=\"3\" style=\"width:623px;\">\n <p>\n <strong>Laboratory ^b </strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n Kelly Ramko</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Laboratory Manager</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n BSc</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n John Mwambi</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Senior Laboratory Technologist</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Dip, Higher Dip</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n Clara Karani</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Laboratory Technologist</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Dip</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n Margaret Nunah</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Laboratory Technologist</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Dip</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:208px;\">\n <p>\n James Chemweno</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n Laboratory Technologist</p>\n </td>\n <td style=\"width:208px;\">\n <p>\n BSc</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n<p>\n ^aSupported by the Clinical Trials Facility, Kilifi</p>\n<p>\n ^bSupported by the Clinical Trials Laboratory and Main KEMRI-Wellcome Trust Research Programme (KWTRP) laboratory in Kilifi</p>\n
      • other_details_explanation<p>\n N/A</p>\n
      • other_details_regulatory_notapproved<p>\n None</p>\n
      • other_details_regulatory_approved<p>\n <strong>Oxford Tropical Research Ethics Committee<br />\n University of Oxford</strong><br />\n Research Services, University Offices<br />\n Wellington Square, Oxford OX1 2JD<br />\n Tel. +44 (0) 1865 (2)82106<br />\n E-mail: oxtrec@admin.ox.ac.uk</p>\n<p>\n Date 22/June/2020.</p>\n<p>\n <strong>KEMRI Scientific and Ethics Review Unit (SERU)</strong></p>\n<p>\n Date 21/July/2020</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_durationParticipants will be involved in the study for 6 months. The sample and data analysis will continue for 1-2 years and a report will be disseminated in 2022.
      • 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_stateYes
      • location_of_areaThe KEMRI-Wellcome Trust Research Programme (KWTRP) Kenya Medical Research Institute (KEMRI) / Wellcome Trust Centre for Geographic Medicine Research – Coast (CGMRC)
      • single_site_physical_addressPO Box 230, Kilifi, Kenya
      • single_site_contact_personProf Dr. Eduard Sanders
      • single_site_telephone+254723593762
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_siteStudy has one site.
      • total_participants_worldwide50 participants.
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameProf. Eduard
      • investigator1_middle_name
      • investigator1_family_nameSanders
      • investigator1_qualificationProf. Dr. MPH,PhD.
      • investigator1_professional_addressPO Box 239, Kilifi 80108
      • investigator1_telephone+254723593-762
      • investigator1_emailESanders@kemri-wellcome.org
      • organisations_transferred_No
      • number_participants50 male and female participants aged 18-25 years
      • notification
      • approval_date10-02-2021
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted01-12-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe study has been approved
      • final_report<p>\n <strong><u>FINAL STUDY REPORT – BEXSERO TRIAL</u></strong></p>\n<p>\n  </p>\n<p>\n KEMRI/SERU/CGMRC/182/3960</p>\n<p>\n  </p>\n<p>\n PPB/ECCT/20/11/01</p>\n<p>\n  </p>\n<p>\n Clinicaltrials.gov NCT04297436</p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n <strong><u>Primary report title: “</u></strong><strong><u>Use of Bexsero immunization to detect cross-reactive antigens and anti-gonococcal antibodies in key populations in Kenya</u></strong><strong><u>.”</u></strong></p>\n<p>\n  </p>\n<ol style=\"list-style-type:upper-alpha;\">\n <li>\n <strong><u>Executive summary</u></strong></li>\n</ol>\n<p>\n  </p>\n<p>\n <strong><em>Introduction</em></strong></p>\n<p>\n Gonorrhoea is a <a href=\"https://www.cdc.gov/std/default.htm#WhatAreSTDs\">sexually transmitted infection</a> that can infect both men and women. It can cause infections in the genitals, rectum, and throat. It is a very common infection, especially among young people aged 18-25 years. Meningococcal disease and gonorrhoea are caused by bacteria that are closely related but cause different diseases that are spread in different ways. New evidence suggests that the Meningococcal B vaccine (Bexsero®) licensed outside of Kenya against meningococcal B disease may also be effective against gonorrhoea due to genetic similarities between the two organisms causing the two diseases. To examine this phenomenon, we conducted a clinical trial of 4CMenB (Bexsero®, GSK), a licensed vaccine against Nm that contains OMVs and recombinant antigens, with 50 adults in coastal Kenya who have high exposure to Ng.</p>\n<p>\n  </p>\n<p>\n <strong><em>Objectives</em></strong></p>\n<p>\n The primary objective of the Bexsero study was to assess if immunisation of individuals at risk for gonococcal infection with 4CMenB (Bexsero®) would enhance an immune response against <em>Neisseria gonorrhoeae</em>.</p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n <strong><em>Study Methodology</em></strong></p>\n<p>\n Fifty young adults (aged 18 - 25 years old) were enrolled in the Bexsero study from existing KEMRI cohort studies (including HIV-uninfected and infected individuals).</p>\n<p>\n  </p>\n<p>\n Screening commenced on 14^th June 2021 and recruitment was completed on 3^rd Sep 2021. No serious adverse events were reported. Follow up visit of the last participant was on 07 February 2022. Four routine monitoring visits have been done over the course of the study and a closeout monitoring was done in July 2022. No major findings were recorded.</p>\n<p>\n  </p>\n<p>\n T-cells ELISpot assays were conducted at KEMRI. Sample shipment for microarray assays was done by colleagues at the University of Manchester, UK.</p>\n<p>\n  </p>\n<p>\n  </p>\n<p>\n <strong><em>Results</em></strong></p>\n<p>\n Between June 2021 and February 2022, a total of 62 participants were screened to receive 4CMenB, with 50 (37 men and 13 women) enrolled and receiving their first vaccination. Subsequently, 47 participants (36 men and 11 women) received a second vaccination (three participants did not complete the second vaccination and were lost to follow-up). Of nine participants living with HIV (three men and six women), eight completed the study (three men and five women). Only one participant had a rectal Ng infection at study completion (GeneXpert positive only). Serum samples were obtained from 50 participants at enrolment (t0) and 47 participants at weeks 10 (t10) and 24 (t24), including the eight participants living with HIV.</p>\n<p>\n  </p>\n<p>\n Using a dedicated microarray of Ng antigens, we showed that serum IgG and IgA reactivities against the gonococcal homologs of the recombinant antigens in the vaccine peaked at 10 weeks but declined by 24 weeks. The reverse was the case for most antigens originating from the OMV component. A cohort of similar patients with laboratory-confirmed gonococcal infection before, during, and after infection showed weaker and different reactivities.</p>\n<p>\n  </p>\n<p>\n <strong>Conclusions</strong>:</p>\n<p>\n We conclude that the cross-protection of the 4CMenB vaccine against gonorrhoea could be explained by cross-reaction against a diverse selection of antigens derived from the OMV component.</p>\n<p>\n  </p>\n<p>\n <strong><em>Discussion of study outcomes</em></strong></p>\n<p>\n  </p>\n<p>\n The aim of this study was to compare antibody responses in vaccinated individuals with those in patients with Ng infection in populations at high risk of gonorrhoea.</p>\n<p>\n  </p>\n<p>\n Antigen microarrays are a powerful means to dissect antibody responses to multi-component vaccines. In this investigation, we were also able to compare these responses directly with a cohort of patients from a similar population.</p>\n<p>\n  </p>\n<p>\n We found that the vaccination trial was sufficiently well controlled to support a comprehensive statistical analysis which identified, in the case of the IgG t24 timepoint, a large number of immunogenic antigens.</p>\n<p>\n  </p>\n<p>\n It was more challenging to differentiate between the before, during and after infection subgroups, given the diversity of infecting strains and differences in the timing of serum collection. Previous studies have found that humoral responses against gonococcal antigens in infected individuals are weak (Hedges <em>et al</em>., 1999); and a variety of mechanisms are employed by the gonococcus to suppress host immunity have been documented (Russell <em>et al</em>., 2021).</p>\n<p>\n  </p>\n<p>\n Studies into cellular immunity as a consequence of Ng infection have been limited to date, with some reports showing that Ng infection leads to the development of cellular immune responses (Viera <em>et al.</em>, 2017), on the contrary, low CD8+ responses were observed in infected female sex workers (Kaul <em>et al.</em>, 2022). These observations prompted us to investigate whether any differences could be detected in IFN-γ production from T-cells by ELISpot, using two pools of peptides identified from T-cell epitope prediction of prominent antigens that are conserved between Nm and Ng. Although we were not able to observe any statistically significant differences compared with controls, the role of cellular immunity in response to both OMV-based vaccines and Ng infection merits further investigation.</p>\n<p>\n  </p>\n<p>\n A retrospective case-control study by Petousis-Harris <em>et al. (2017)</em> provided the first evidence for a reduction in the incidence of gonorrhoea in young adults in New Zealand who had received three doses of an OMV-based Nm vaccine. Although the estimated vaccine effectiveness was low (31%), this observation has been verified by several subsequent studies (Bruxvoort KJ, <em>et al</em>. 2023; Robison SG, <em>et al</em>, 2023).</p>\n<p>\n  </p>\n<p>\n Our observations suggest that IgG and IgA antibodies against the recombinant antigens in 4CMenB are in decline by the 24-week period post vaccination and likely continue to fall after that timepoint.</p>\n<p>\n There are important ramifications from our study for Ng vaccine design. The challenges inherent in Ng vaccine development are well recognised (Russell <em>et al</em>, 2019): one major problem is that native immune responses to genital tract infection by Ng are not protective (Liu YR, <em>et al</em>. 2018. The limited protective effect of 4CMenB against gonorrhoea is a valuable clue, implying that cross-protection induced through meningococcal antigens, combined with the adjuvant properties of the OMV itself, could be responsible. Our study suggests that devising a vaccine against gonorrhoea does not merely require selection of component antigens and adjuvants, but a consideration of how the whole formulation is able to induce long-lasting, protective immunity.</p>\n<p>\n  </p>\n<p>\n End</p>\n<p>\n  </p>\n
      • implication_results
      • quantity_imported104
      • quantity_dispensed97
      • quantity_destroyed7
      • quantity_exported0
      • balance_site0
      • final_date0000-00-00
      • modified2024-02-06 13:01:12
      • created2020-11-03 09:43:54
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        • id602
        • application_id956
        • given_nameProf. Eduard
        • middle_name
        • family_nameSanders
        • qualificationProf. Dr. MPH,PhD.
        • professional_addressPO Box 239, Kilifi 80108
        • telephone+254723593-762
        • emailESanders@kemri-wellcome.org
        • created2020-11-03 09:56:25
        • modified2020-12-01 11:02:34
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    • Sponsor(array)
      • 0(array)
        • id466
        • application_id956
        • sponsorUniversity of Oxford University Offices, Wellington Square, Oxford OX1 2JD
        • sponsor_typeResearch Institution
        • contact_personProf. Christoph Tang, Professor of Pathology, Chief investigator, Gonococcal Vaccine
        • addressUniversity of Oxford University Offices, Wellington Square, Oxford OX1 2JD
        • telephone_number+44 1865 572245
        • fax_number
        • cell_number+44 1865 572245
        • email_addressctrg@admin.ox.ac.uk
        • created2020-11-03 09:56:25
        • modified2020-12-01 11:02:34
  • 1(array)
    • Application(array)
      • id954
      • user_id664
      • trial_status_id4
      • abstract_of_study<p>\n <strong>Background: </strong>SCD is caused by a specific point mutation in the gene encoding hemoglobin (Hb) sub unit beta that leads to the production of abnormal Hb (“sickle hemoglobin” or HbS). Under conditions of hypoxia, acidity, and/or dehydration, the intracellular concentration of</p>\n<p>\n deoxygenated HbS increases, which favors its polymerization and causes RBCs to deform (i.e., sickle) or become rigid, leading to a complex cascade of hemolysis, inflammation, elevated cell adhesion, leukocytosis, oxidative stress, and endothelial dysfunction that culminates in the vascular obstruction and ischemia responsible for much of the observed morbidity in SCD.  The most common manifestations of SCD include vaso-occlusive crisis (VOC), chronic and acute severe pain, acute chest syndrome (ACS), stroke, priapism, acute anemia (particularly from aplastic crisis and splenic sequestration), increased susceptibility to infection, and progressive damage to major organs, including the spleen, brain, kidney, heart, lung, skin, retina, vestibular cochlear systems, and bone. In developed countries where there is prenatal screening and widespread access to prophylactic and acute interventions, the median age of death remains in the 40s to 50s.  In low resource countries, however, many patients succumb to the disease much earlier. Prior to July 2017, the only drug specifically approved for the treatment of SCD was hydroxyurea (HU).  In July 2017, L-glutamine oral powder (Endari™) was approved in the US to reduce complications of SCD. In November 2019, crizanlizumab and voxelotor were approved by the Food and Drug Administration (FDA). Due to the current cost of voxelotor and crizanlizumab, these therapies may not be accessible globally, especially for patients in resource-poor countries. Thus, additional accessible, novel, safe, and effective treatments to prevent the morbid complications of SCD in patients of all ages are still urgently needed. The sponsor, IMARA is developing IMR-687 for the treatment of patients with sickle cell disease (SCD) and β-thalassemia. IMR-687 is a potent, specific, and highly selective small molecule inhibitor of phosphodiesterase type 9 (PDE9); PDE9 mediates cellular signaling pathways by degrading cGMP to its inactive or monophosphate form. By inhibiting PDE9, IMR-687 is intended to increase cGMP levels and thus stimulate the production of HbF, which reduces the cellular concentration of abnormal Hb (HbS) within RBCs and its associated sequelae.</p>\n<p>\n  </p>\n<p>\n <strong>Objectives</strong>: To evaluate the HbF response to IMR-687 versus placebo and to evaluate the safety of IMR-687 versus placebo.</p>\n<p>\n  </p>\n<p>\n <strong>Methods:</strong> This is a phase 2b, randomized, double-blind, placebo-controlled, multicenter study of subjects aged 18 to 65 years with sickle cell disease (SCD; homozygous sickle hemoglobin [HbSS], sickle-β0 [HbSB0] thalassemia, or sickle-β+ [HbSB+] thalassemia) to evaluate the safety and efficacy of the phosphodiesterase type 9 (PDE9) inhibitor, IMR-687, administered once daily (qd) for 52 weeks. This study will enroll approximately 99 subjects with SCD. This study consists of a screening period (up to 4 weeks), a double-blind treatment period (52 weeks), and a safety follow-up period (4 weeks).</p>\n<p>\n <em>Screening: </em>After providing documented informed consent, subjects fulfilling the inclusion criteria  will enter an up to 28-day screening period. The following information will be obtained and procedures will be performed for all potential subjects at the screening visit: medical/disease history, vital signs, electrocardiogram (ECG), complete physical examination (PE), laboratory tests (including safety, specialty hematology, and pharmacodynamic [PD] assessments). For a complete list of screening procedures, refer to the schedule of assessments.</p>\n<p>\n <em>Treatment Period: </em>Subjects will receive either IMR-687 (lower dose [≥3.0 to ≤4.5 mg/kg] or higher dose [>4.5 to ≤6.7 mg/kg]) or placebo in a blinded fashion. Initially, subjects will be randomly assigned in a 2:1 ratio to receive either IMR-687 lower dose or placebo. Prior to the introduction of IMR-687 higher dose, the Data Monitoring Committee (DMC) will review safety data for at least 5 subjects who received IMR-687. If the DMC recommends inclusion of the higher dose, randomization will then proceed in a 1:2:1 ratio (IMR-687 lower dose, IMR-687 higher dose, or placebo). The DMC may request additional data and/or meeting(s) in order to make the recommendation on whether to move forward with inclusion of the higher dose.</p>\n<p>\n Subjects may or may not be concomitantly receiving a stable dose of hydroxyurea (HU) according to</p>\n<p>\n the subject’s established treatment plan. Randomization will be stratified by use of HU and by region. </p>\n<p>\n Subjects will return to the investigational site at Week 1 for a safety assessment, and qualified site</p>\n<p>\n personnel will contact the subject by telephone at Week 2 and Week 6 to capture potential adverse</p>\n<p>\n events (AEs) and concomitant medications. Subjects will be seen at the investigational site approximately every 4 weeks through Week 36 and then every 12 weeks through Week 52 (end of treatment), with a safety follow-up visit at Week 56 (end of study). Safety will be monitored throughout the study, and pharmacokinetics (PK), PD, quality of life (QoL), and clinical outcome measures will be performed at the visits shown in the schedule of assessments for (Table 1, in the protocol). QoL assessments include the Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me®), Patient-Reported Outcomes Measurements Information System - Preference (PROMIS® 29 + 2 Profile v2.1 [PROPr]), and Sickle Cell Self-Efficacy Scale (SCSES).</p>\n<p>\n <em>Data analysis: </em>HbF response will be analyzed using a stratified Cochran-Mantel-Haenszel (CMH) test based on stratification factors of HU use and region to compare the proportion of patients achieving HbF response of each dose of IMR-687 to placebo. An interim analysis (IA) will be performed after 33 subjects have reached Week 24, and a primary analysis will be performed after all subjects have reached Week 24 or terminated early.  A final analysis will be conducted at study completion (i.e., when all subjects have reached Week 56 or terminated early).</p>\n<p>\n <em>Ethical considerations: </em>The Gertrude’s Children’s Ethical Review Board has approved the study (</p>\n<p>\n <strong>Open-label Extension</strong>: Subjects who complete this study may be eligible to enrol in an open-label extension (OLE) study. Details of the OLE study will be provided in a separate protocol.</p>\n<p>\n <strong>Endpoints: </strong>The Primary Efficacy Endpoint will be Subject response as defined by an increase of ≥3% in HbF from baseline to Week 24.  The Safety Endpoints will be the AEs, SAEs, clinically significant changes in laboratory tests, clinically significant changes in vital signs, and clinically significant changes in ECGs</p>\n
      • study_title<div>\n A Phase 2b Study to Evaluate the Safety and Efficacy of IMR-687 in Subjects with Sickle Cell Disease</div>\n<div>\n  </div>\n
      • laymans_summary<p>\n Sickle Cell Disease is an uncommon disease that is inherited and affects the production of Hemoglobin (Hb). Hb is a protein in red blood cells that carries oxygen from the lungs to the rest of the body. In people who are living with Sickle Cell Disease, the hemoglobin deforms the red blood cell into a sticky and rigid sickle shaped cell, which may cause a lack of oxygen in many parts of the body. The disease may ultimately lead to the damage of many organs such as kidneys, liver, heart, brain, joints,  can ultimately lead to organ damage.  Currently there are very few treatments that are specifically approved for treatment of sickle cell disease.  Therefore, this study whose purpose is to evaluate how safe and well-tolerated a new drug called IMR-687 is in participants with Sickle Cell Disease. IMR-687 helps to stimulate the production of normal haemoglobin by inhibiting the production of abnormal haemoglobin. Participants will be randomly assigned (like flipping a coin) to 1 of 2 treatment groups which include treatment with a low dose of IMR-687 or placebo. Some participants may be given a higher dose of IMR-687 after reviewing safety data from 5 participants receiving the low dose of IMR-687.</p>\n<p>\n The planned duration of study participation is approximately 60 weeks consisting of: screening period (4 weeks), treatment period (52 weeks) and safety follow-up assessment (4 weeks). Participants will be expected to take two tablets once a day for 52 weeks.  Safety assessments will be done throughout the study.</p>\n<p>\n IMARA, Inc., is the pharmaceutical company that will be funding this research study.</p>\n
      • short_titleIMR-SCD-301
      • protocol_noECCT/20/11/03
      • version_no3
      • date_of_protocol29-01-2020
      • study_drugIMR-687
      • disease_conditionsickle 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_name6-[(3S,4S)-4-methyl-1-(pyrimidin-2-ylmethyl)pyrrolidin-3-yl]-3-tetrahydropyran-4-yl-7H-imidazo[1,5- a] pyrazin-8-one
      • product_type_medical_device_name
      • comparatorNo
      • comparator_nameN/A
      • comparator_registeredN/A
      • comparator_countriesN/A
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressjgithanga3@gmail.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_applicantProf Jessie N. Githanga
      • declaration_date116-11-2020
      • declaration_principal_investigatorPrincipal Investigator at site (Gertrude\'s Children\'s Hospital
      • declaration_date216-11-2020
      • placebo_presentYes
      • study_objectives<div>\n Primary Objectives</div>\n<div>\n • To evaluate the HbF response to IMR-687 versus placebo</div>\n<div>\n • To evaluate the safety of IMR-687 versus placebo</div>\n<div>\n <div>\n Secondary Efficacy Objectives</div>\n <div>\n • To evaluate the effect of IMR-687 versus placebo on HbF-associated biomarkers</div>\n <div>\n • To evaluate the effect of IMR-687 versus placebo on indices of red cell hemolysis</div>\n <div>\n • To evaluate the effect of IMR-687 versus placebo on indices of WBC adhesion</div>\n <div>\n • To evaluate the effect of IMR-687 versus placebo on the incidence of VOCs</div>\n <div>\n • To evaluate the effect of IMR-687 versus placebo on quality of life (QoL) measures</div>\n <div>\n Pharmacokinetic Objectives</div>\n</div>\n<div>\n • To evaluate the PK of IMR-687 and any major circulating metabolites</div>\n<div>\n Exploratory Efficacy Objectives</div>\n<div>\n • To evaluate the effect of IMR-687 versus placebo on changes in RBC characteristics</div>\n<div>\n and total Hb</div>\n<div>\n • To evaluate the effect of IMR-687 versus placebo on renal function</div>\n<div>\n • To evaluate the effect of IMR-687 versus placebo on indices associated with</div>\n<div>\n cardiovascular pathophysiology and ischemic stroke risk</div>\n
      • principal_inclusion_criteria<div>\n 1. Male or female aged ≥18 to ≤65 years at the time of ICF signing.</div>\n<div>\n 2. Confirmed diagnosis of SCD (HbSS, HbSB0 thalassemia, or HbSB+ thalassemia) in the medical record; if not available, the diagnosis must be confirmed at the site’s local laboratory instead.</div>\n<div>\n 3. Subjects must have had at least 1 and no more than 12 documented episodes of VOC in the past 12 months at the time of ICF signing and at randomization (Day 1).</div>\n<div>\n 4. Hb of >5.5 and <10.5 g/dL.</div>\n<div>\n 5. Absolute reticulocyte count ≥80 × 109/L.</div>\n<div>\n 6. Subjects receiving HU must have received it continuously for at least 6 months prior to signing the ICF, and must have been on a stable dose for at least 3 months prior to signing the ICF, with no anticipated need for dose adjustments during the study including the screening period, in the opinion of the investigator.</div>\n<div>\n 7. Female subjects must not be pregnant or breastfeeding and be highly unlikely to become pregnant. Male subjects must be unlikely to impregnate a partner. </div>\n<div>\n <div>\n 8. Be capable of giving informed consent and reading and signing the ICF </div>\n <div>\n 9. Be willing and able to complete all study assessments and procedures and to communicate effectively with the investigator and site staff.</div>\n</div>\n<div>\n  </div>\n
      • principal_exclusion_criteria<div>\n 1. Hospital discharge for sickle cell crisis or other vaso-occlusive event within the 4 days prior to randomization (Day 1).</div>\n<div>\n 2. RBC transfusion within 60 days of signing the ICF or on chronic transfusion therapy regimen. Transfusion status must be reassessed at randomization (Day 1).</div>\n<div>\n Note: If a subject requires a transfusion during the screening period, they may be rescreened up to one time.</div>\n<div>\n 3. Subjects with hereditary persistence of HbF (i.e., HbF >25% at screening).</div>\n<div>\n 4. Subjects with known active hepatitis A, hepatitis B, or hepatitis C, with active or acute event of malaria, or who are known to be positive for human immunodeficiency</div>\n<div>\n virus (HIV).</div>\n<div>\n <div>\n For female subjects of childbearing potential, a positive serum human chorionic gonadotropin (hCG) test (screening) or a positive urine hCG test at randomization</div>\n <div>\n (Day 1).</div>\n <div>\n 6. Estimated glomerular filtration rate (eGFR) <45 mL/min as calculated by the equation from the Modification of Diet in Renal Disease Study using creatinine, age,</div>\n <div>\n sex, and ethnicity.</div>\n <div>\n 7. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 × the upper limit of normal (ULN).</div>\n <div>\n 8. Body mass index (BMI) <17.0 kg/m2 and a total body weight <45 kg; or BMI >35 kg/m2.</div>\n <div>\n 9. Current or history of malignancies (solid tumors and hematological malignancies), unless the subject has been free of the disease (including completion of any active or adjuvant treatment for prior malignancy) for ≥5 years (some exceptions for controlled disease - see full proposal pg 45)</div>\n <div>\n 10. A history of a clinically significant allergic reaction or hypersensitivity, as judged by the investigator, to any drug or any component of the study drug formulations used in the study (see Investigator’s Brochure).</div>\n <div>\n <div>\n 11. History of unstable or deteriorating cardiac or pulmonary disease within 6 months before signing the ICF.</div>\n <div>\n 12. Any condition affecting drug absorption, such as major surgery involving the stomach or small intestine (prior cholecystectomy is acceptable).</div>\n <div>\n 13. On ECG testing at ICF signing and/or randomization (Day 1), a corrected QT interval, Fridericia’s formula (QTcF) >450 ms in men and >470 ms in women or the</div>\n <div>\n presence of clinically significant ECG abnormalities as determined by the investigator.</div>\n <div>\n 14. A history of major surgery within 4 weeks or minor surgery within 2 weeks of randomization (Day 1).</div>\n <div>\n 15. Stroke requiring medical intervention within 24 weeks prior to randomization (Day 1).</div>\n </div>\n</div>\n<div>\n 16. Subjects taking DOACs apixaban, dabigatran, rivaroxaban, edoxaban, or ticagrelor, or taking warfarin, are excluded unless they stopped the treatment at least</div>\n<div>\n 28 days prior to randomization (Day 1); other oral anti-coagulants and anti-platelet drugs are permitted.Anti-coagulant therapies for prophylaxis of venous</div>\n<div>\n thromboembolism, including pulmonary emboli including when undergoing surgery or high-risk procedures, are allowed if low molecular weight heparins are used in the peri-operative period. Aspirin use is allowed before and during the study.</div>\n<div>\n 17. Poorly controlled diabetes mellitus </div>\n<div>\n 18. Subject has received chronic systemic glucocorticoids within 12 weeks prior to randomization (≥5 mg/day). Physiologic replacement therapy for adrenal</div>\n<div>\n insufficiency is allowed.</div>\n<div>\n 19. Any clinically significant bacterial, fungal, parasitic, or viral infection requiring antibiotic therapy should delay screening/randomization (Day 1) until the course of</div>\n<div>\n antibiotic therapy has been completed. This includes, but is not limited to, long-term tuberculosis treatment.</div>\n<div>\n 20. Participated in another clinical study of an investigational agent (or medical device) within 30 days or 5 half-lives of date of informed consent, whichever is longer, or is currently participating in another study of an investigational agent (or medical device).</div>\n<div>\n <div>\n 21. Prior exposure to IMR-687.</div>\n <div>\n 22. A history of use of crizanlizumab or voxelotor within 6 months prior to signing the ICF.</div>\n <div>\n 23. Consumption/use of the following drugs or other substances within the specified time periods before randomization or plans to consume/use at any time during the study. a. PDE type 5 inhibitors within 7 days prior to randomization (Day 1) b. Grapefruit, grapefruit juice, grapefruit products, or herbal supplements with CYP altering abilities within 1 week prior to randomization (Day 1) c. CYP3A-sensitive substrates, , or moderate to strong CYP3A inhibitors or inducers within 28 days prior to randomization (Day 1) d. Any drugs or substances known to be substrates or inhibitors of P-gp or BCRP within 28 days prior to randomization (Day 1)</div>\n <div>\n 24. Receipt of erythropoietin or other hematopoietic growth factor treatment within 3 months of signing the ICF or anticipated need for such agents during the study.</div>\n <div>\n 25. Prior gene therapy.</div>\n <div>\n 26. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study, including the presence of laboratory abnormalities that may place the subject at unacceptable risk if he/she were to participate in the study.</div>\n <div>\n 27. Other prior or ongoing medical condition, physical findings, or laboratory abnormality that, in the investigator’s opinion, could adversely affect the safety of the subject, make it unlikely that the course of treatment or follow up would be completed, or impair the assessment of study results (e.g., a history of drug or alcohol abuse within the past 1 year, as judged by the investigator).</div>\n</div>\n<p>\n  </p>\n
      • primary_end_points<div>\n Primary Efficacy Endpoint: Subject response as defined by an increase of ≥3% in HbF from baseline to Week 24</div>\n<div>\n Safety Endpoints: AEs, SAEs, clinically significant changes in laboratory tests, clinically significant changes in vital signs, and clinically significant changes in ECGs</div>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic1
      • 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_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n Gertrude’s Children’s Hospital (GCH) is the largest hospital in East and Central Africa dedicated exclusively to the care of children. The over 100-bed hospital offers comprehensive paediatric medical services and there are 21 specialist clinics that cover almost every aspect of paediatric healthcare from haematology, chest conditions, cardiology, dermatology, otorhinolaryngology, endocrinology, oncology and HIV/AIDS. The laboratory is equipped with modern equipment and offers diagnostic laboratory testing in all areas of pathology and is headed by a pathologist supported by several other pathologists, laboratory manager and qualified medical laboratory technologists. The laboratory is accredited by Kenya Accreditation Service (KENAS) as a medical testing laboratory (ISO15189:2012).  Qualified pharmacists manage the hospital pharmacy.  GCH has an up-to-date paediatric imaging facility that is managed by a team of radiologists and qualified radiographers.  Most of the processes at the hospital are fully computerized and supported by a well-integrate Information Technology (IT) Department.   The main hospital in Muthaiga is open 24/7 and offers 24-hour laboratory and pharmacy coverage.  The Accident and Emergency Department is well equipped to deal with all forms of paediatric emergencies and has a crash cart and crash team on call, 24 hours a day.   There are registered nurses, medical officers and specialists specifically trained in Emergency Triage Assessment and Treatment (ETAT).  The Team is fully trained to handle emergencies, including but not limited to airway obstruction and other breathing problems; circulatory impairment or shock; severely altered central nervous system function (coma or convulsive seizures); and severe dehydration which require urgent appropriate care to prevent death.The Hospital has an Ethics Review Board (ERB) that acts independently from the appointing authority, hosting institution, researchers, sponsors and any other stakeholders in its review and decision-making processes.  The ERC is accredited by the National Commission for Science and Technology and Innovation (NACOSTI).</p>\n<p>\n 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.  </p>\n<ul>\n <li>\n Dr. Doreen Karimi Mutua: Sub-Investigator.  Paediatric haemato-oncologist with experience in participating in several clinical trials and is GCP trained.</li>\n <li>\n Dr Joy Githua: Study Coordinator: <span style=\"font-size: 11pt; line-height: 107%; font-family: Calibri, 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. She has been trained in GCP </span>Medical doctor, GCP trained ng and onboarding as a </li>\n <li>\n Dr Samuel Madere: Qualified pharmacist, registered by the PPB, and GCP trained. Has experience in participating in several clinical trials</li>\n <li>\n Dr Ibrahim Okitch: Qualified pharmacist, registered by the PPB, and GCP trained</li>\n <li>\n Hannah Wanjiku: Study Nurse/assistant coordinator. Working at GCH, registered by the Nursing Council of Kenya, GCP trained. Has experience in participating in several clinical trials</li>\n <li>\n Felicity Kamundi: Study Nurse. Working at GCH, registered by the Nursing Council of Kenya, GCP trained. Has experience in participating in several clinical trials</li>\n <li>\n Peninah Chege:Laboratory manager registered by the Kenya Medical Laboratory Technologists and Technicians Board (KMLTTB), GCP trained will coordinate laboratory functions</li>\n <li>\n Charles Muia: Medical Laboratory technologist. Registered by the KMLTTB, GCP trained, working at GCH</li>\n <li>\n Herman Akumu: Medical Laboratory technologist. Registered by the KMLTTB, GCP trained, working at GCH</li>\n <li>\n Joseph Langat : Phlebotomist. Trained in phlebotomy and GCP and working at GCH</li>\n <li>\n Winnie Abuto: Quality Assurance Officer Nurse registered by the Nursing Council of Kenya, and GCP trained. Has participated in several clinical trials.</li>\n</ul>\n
      • other_details_explanation<p>\n N/A as the trial is also being run in the USA</p>\n
      • other_details_regulatory_notapproved<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:113px;\">\n <p>\n <strong>Country</strong></p>\n <p>\n <strong>No sites</strong></p>\n </td>\n <td style=\"width:322px;\">\n <p>\n <strong>Competent Authority</strong></p>\n </td>\n <td style=\"width:167px;\">\n <p>\n <strong>Decision</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:113px;\">\n <p>\n Ghana (2 sites)</p>\n </td>\n <td style=\"width:322px;\">\n <p>\n Food and Drugs Authority</p>\n <p>\n P. O. Box CT 2783, Cantonments – Accra, Ghana</p>\n </td>\n <td style=\"width:167px;\">\n <p>\n Under review;</p>\n <p>\n submitted on 29-Jul-20</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:113px;\">\n <p>\n Greece (3 sites)</p>\n </td>\n <td style=\"width:322px;\">\n <p>\n National Organization for Medicines</p>\n <p>\n Messogion Avenue 284, Cholargos,</p>\n <p>\n 15562 Athens</p>\n <p>\n Greece</p>\n </td>\n <td style=\"width:167px;\">\n <p>\n Under review;</p>\n <p>\n submitted on 01-Sep-20</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:113px;\">\n <p>\n Kenya (3 sites)</p>\n </td>\n <td style=\"width:322px;\">\n <p>\n Pharmacy and Poisons Board</p>\n <p>\n P.O. Box 27663-00506</p>\n <p>\n Lenana Road Opp. DOD</p>\n <p>\n Nairobi, Kenya</p>\n <p>\n  </p>\n </td>\n <td style=\"width:167px;\">\n <p>\n To be submitted</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:113px;\">\n <p>\n Oman (1 site)</p>\n </td>\n <td style=\"width:322px;\">\n <p>\n Sultanate of Oman MOH, directorate general of pharmaceuticals affairs and drug control<br />\n Al-Khuwair, Muscat, Oman</p>\n </td>\n <td style=\"width:167px;\">\n <p>\n To be submitted</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:113px;\">\n <p>\n Senegal (1 site)</p>\n </td>\n <td style=\"width:322px;\">\n <p>\n Direction de la Pharmacie et du Médicament</p>\n <p>\n 53 rue Mousse DIOP angle Victor HUGO, BP6150,</p>\n <p>\n Dakar, Senegal</p>\n </td>\n <td style=\"width:167px;\">\n <p>\n To be submitted</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:113px;\">\n <p>\n Uganda (5 sites)</p>\n </td>\n <td style=\"width:322px;\">\n <p>\n National Drug Authority<br />\n Secretariat Office Kampala<br />\n Plot 19 Lumumba Avenue<br />\n P.O. Box 23096<br />\n Kampala, Uganda</p>\n </td>\n <td style=\"width:167px;\">\n <p>\n To be submitted</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_regulatory_approved<table align=\"left\" border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:123px;\">\n <p>\n <strong>Country</strong></p>\n <p>\n <strong>No of Sites</strong></p>\n </td>\n <td style=\"width:369px;\">\n <p>\n <strong>Competent Authority</strong></p>\n </td>\n <td style=\"width:110px;\">\n <p>\n <strong>Decision</strong></p>\n </td>\n </tr>\n <tr>\n <td style=\"width:123px;\">\n <p>\n Egypt (4 sites)</p>\n </td>\n <td style=\"width:369px;\">\n <p>\n Ministry of Health & Population</p>\n <p>\n 3 Magles El Shaab St., Cairo</p>\n <p>\n The new administrative building – floor 7/P.O.: 11516</p>\n <p>\n Egypt</p>\n </td>\n <td style=\"width:110px;\">\n <p>\n Conditional approval on</p>\n <p>\n  01-Oct-20</p>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:123px;\">\n <p>\n Italy (5 sites)</p>\n </td>\n <td style=\"width:369px;\">\n <p>\n AIFA-Ufficio Sperimentazione Clinica</p>\n <p>\n Via del Tritone, 181</p>\n <p>\n 00187 Roma</p>\n <p>\n Italy</p>\n </td>\n <td style=\"width:110px;\">\n <p>\n Approved on 15-Sep-20.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:123px;\">\n <p>\n Lebanon (3 sites)</p>\n </td>\n <td style=\"width:369px;\">\n <p>\n Ministry of Public Health</p>\n <p>\n Bir Hassan, Jnah, next to Ogero</p>\n <p>\n Beirut</p>\n <p>\n Lebanon</p>\n </td>\n <td style=\"width:110px;\">\n <p>\n Approved on 18-Sep-20.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:123px;\">\n <p>\n Morocco (2 sites)</p>\n </td>\n <td style=\"width:369px;\">\n <p>\n Direction du Médicament et de la Pharmacy (DMP)</p>\n <p>\n Rue Lafadal Charkaoui</p>\n <p>\n B.P. 6206 – Rabot Institut</p>\n <p>\n Maroc</p>\n </td>\n <td style=\"width:110px;\">\n <p>\n Conditional approval on</p>\n <p>\n 02-Nov-20.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:123px;\">\n <p>\n Netherlands (1 site)</p>\n </td>\n <td style=\"width:369px;\">\n <p>\n Central Committee on Research Involving Human Subjects (CCMO)</p>\n <p>\n Parnassusplein 5</p>\n <p>\n 2511VX Den Haag</p>\n <p>\n The Netherlands</p>\n <p>\n  </p>\n </td>\n <td style=\"width:110px;\">\n <p>\n Approved on 15-Jun-20</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:123px;\">\n <p>\n Tunisia (4 sites)</p>\n </td>\n <td style=\"width:369px;\">\n <p>\n Ministère de le santé [Ministry of Health], Direction de la Pharmacie et du Médicament [Board of Pharmacy and Drugs]<br />\n 31, Rue de Khartoum, Tunis, Belvédère</p>\n <p>\n Tunisia</p>\n <p>\n  </p>\n </td>\n <td style=\"width:110px;\">\n <p>\n Approved on 08-Oct-20</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:123px;\">\n <p>\n United Kingdom (6 sites)</p>\n </td>\n <td style=\"width:369px;\">\n <p>\n Medicines and Healthcare products Regulatory Agency</p>\n <p>\n 10 South Colonnade</p>\n <p>\n Canary Wharf,</p>\n <p>\n London E14 4PU</p>\n <p>\n United Kingdom</p>\n </td>\n <td style=\"width:110px;\">\n <p>\n Approved on 24-Jun-20</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:123px;\">\n <p>\n United States (13 sites)</p>\n </td>\n <td style=\"width:369px;\">\n <p>\n Food and Drug Administration,</p>\n <p>\n 10903 New Hampshire Ave</p>\n <p>\n Silver Spring, MD 20993</p>\n <p>\n 1-888-INFO-FDA</p>\n <p>\n United States </p>\n </td>\n <td style=\"width:110px;\">\n <p>\n Approved on 16-Jul-20</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_regulatory_rejected<p>\n N/A</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration3 years
      • 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_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_states70 sites in several states
      • number_of_sites3
      • multi_country_listNorth America, Europe, Africa, Middle East, and Asia
      • data_monitoring_committeeYes
      • total_enrolment_per_site10 - 20 patients per site
      • total_participants_worldwide99
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyNo
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingYes
      • subjects_women_using_contraceptionYes
      • subjects_pregnant_womenNo
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameBernhards
      • investigator1_middle_name
      • investigator1_family_nameOgutu
      • investigator1_qualificationMBChB, MMed (Paeds), PhD
      • investigator1_professional_addressCenter For Research In Therapeutic Sciences(CREATES), P.O. Box 59857-00200,Ole Sangale Road, off Langata Road, in Madaraka Estate, Nairobi, Kenya
      • investigator1_telephone+254 733966065
      • investigator1_emailogutu@gmail.com
      • organisations_transferred_Yes
      • number_participants36
      • notification<p>\n Documents submitted as per checklist have been uploaded. </p>\n<p>\n Other documents related to the study as per application cover letter are available. Some have been uploaded above in addition:</p>\n<p>\n - Patient questionaires and cards</p>\n<p>\n - medicinal product information </p>\n<p>\n - Protocol related information, eCRF, medicinal product dossier etc, </p>\n<p>\n  </p>\n
      • approval_date24-02-2021
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted03-02-2021
      • 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(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2023-02-08 16:01:51
      • created2020-10-28 14:00:16
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id601
        • application_id954
        • given_nameJessie
        • middle_nameNyokabi
        • family_nameGithanga
        • qualificationMBCHB, MMed Path, FCPath-ECSA
        • professional_addressUniversity of Nairobi, College of Health Sciences, Department of Human Pathology, P. O. Box 19676-00202, KNH, Nairobi, Kenya
        • telephone+254721245721
        • emailjgithanga3@gmail.com
        • created2020-10-28 14:54:55
        • modified2021-02-03 18:23:42
      • 1(array)
        • id615
        • application_id954
        • given_nameVidelis
        • middle_name
        • family_nameNduba
        • qualificationMBChB, MPH, PhD
        • professional_addressKEMRI (CRDR) Clinical Research Annex, KNH Complex, off Hospital Road
        • telephone+254724522474
        • emailvnduba@gmail.com
        • created2021-01-26 09:05:45
        • modified2021-02-03 18:23:42
    • SiteDetail(array)
      • 0(array)
        • id831
        • application_id954
        • county_id42
        • site_nameKenya Medical Research Institute-Kondele Children\'s Hospital
        • physical_addressKenya Medical Research Institute-Kondele Children-Hospital, Kisumu, Kenya
        • contact_detailsP.O. Box 1578-40100-Kisumu, Kenya; Tel: +254 (20) 22923
        • contact_personProf Bernhards Ogutu Tel: +254733812613
        • site_capacity(null)
        • misc(null)
        • created2020-10-28 14:54:55
        • modified2021-02-03 18:23:42
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 1(array)
        • id833
        • application_id954
        • county_id47
        • site_nameThe Center For Respiratory Disease Research/KEMRI
        • physical_addressCRDR Clinical Trial Annex, Mbagathi Road, Nairobi
        • contact_details P O Box 47855-00100, Nairobi, Tel: +254-020-2719601 / +254-020-2724264/5
        • contact_personDr Videlis Nduba tel : +254 724522474
        • site_capacity(null)
        • misc(null)
        • created2020-11-03 12:23:39
        • modified2021-02-03 18:23:42
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 2(array)
        • id834
        • application_id954
        • county_id47
        • site_nameGertrude\'s Children\'s Hospital
        • physical_address34 Muthaiga Road, Off Thika Super Highway, Muthaiga, Nairobi
        • contact_detailsPO BOX 42325- 00100, Nairobi Tel: +254 020 7206000 +254 722898948
        • contact_personProf Jessie Githanga tel: +254 721245721
        • site_capacity(null)
        • misc(null)
        • created2020-11-03 12:23:39
        • modified2021-02-03 18:23:42
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
    • Sponsor(array)
      • 0(array)
        • id465
        • application_id954
        • sponsorIMARA, Inc
        • sponsor_typeIndustry
        • contact_personEleanor Lisbon, MD, MPH
        • address116 Huntington Avenue, 6th Floor, Boston, MA 02116, USA
        • telephone_number+1 913 449 4319
        • fax_numberN/A
        • cell_number+1 913 449 4319
        • email_addresselisbon@imaratx.com
        • created2020-10-28 14:54:55
        • modified2021-02-03 18:23:42
  • 2(array)
    • Application(array)
      • id952
      • user_id658
      • trial_status_id(null)
      • abstract_of_study<p>\n No previous study of fetal pulse oximetry has accurately determined intrapartum fetal oxygenation. We describe a trial for the use of a novel type of fetal pulse oximetry device that, while in labor, touches the fetal presenting part in a non-invasive way, reads the fetal oxygen content and stores the data so the results are masked to those attending the parturient, allowing labor to be managed without prejudice. </p>\n<p>\n This will be a non-randomized clinical trial. The results of the novel fetal oximeter readings, once unmasked, will be compared to the clinically acceptable measures of fetal wellbeing in labor in our unit, that is, cardiotocogram (CTG) and scalp stimulation test in labor in guiding labor management choices, predicting cord blood gas results at delivery of the fetus and fetal outcomes.</p>\n<p>\n The hypothesis is that the use of this novel pulse oximeter device will be an acceptable clinical comparison to other methods of determining fetal well-being in labor.</p>\n<p>\n  </p>\n
      • study_title<p>\n <strong>The use of Fetal Pulse Oximetry in determining fetal wellbeing during labour: A non-randomized clinical trial</strong></p>\n<p>\n  </p>\n
      • laymans_summary<p>\n Accurate monitoring of fetal well being during the labor process is a challenging process. Various monitoring methods currently in use have various shortcoming and are not able to provide a good prediction of the baby outcomes. This led to the development of the fetal pulse oximeter to try bridge thhese shortcomings. By directly measuring the oxygenation status of the baby during the labor process, we hope to detect fetal compromise early and this can be a good adjunct to the available methods of fetal monitoring in labor. </p>\n<p>\n  </p>\n
      • short_titlePulse oximeter use in labour
      • protocol_noECCT/21/06/11
      • version_no1
      • date_of_protocol15-10-2020
      • study_drugFirst Touchâ„¢
      • disease_conditionFetal oxygenation during labour
      • product_type_biologicals0
      • product_type_proteins0
      • product_type_immunologicals0
      • product_type_vaccines0
      • product_type_hormones0
      • product_type_toxoid0
      • product_type_chemical0
      • product_type_medical_device1
      • product_type_chemical_name
      • product_type_medical_device_nameFetal pulse oximetry
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressdroindi@gmail.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_addendum0
      • 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_applicant0723499586
      • declaration_date117-06-2021
      • declaration_principal_investigatorFelix Oindi, Principal Investigator
      • declaration_date217-06-2021
      • placebo_presentNo
      • study_objectives<p>\n <strong>Primary Objective:</strong> To evaluate the use of an intrauterine fetal pulse oximeter device in comparison to other methods of fetal monitoring in determining fetal well-being in labour.</p>\n<p>\n <strong>Secondary Objectives.</strong></p>\n<ul style=\"list-style-type:circle;\">\n <li>\n To evaluate the value of fetal oxygen determination in the second stage of labor?</li>\n <li>\n To assess the possibility of a true predictive value of the 60% critical threshold value and whether it will always be associated with pathological CTG/cord blood gases?</li>\n</ul>\n<p>\n  </p>\n
      • principal_inclusion_criteria<p>\n 1. 18 years of age or older</p>\n<p>\n 2. Singleton gestation</p>\n<p>\n 3. More than 34 weeks’ gestation</p>\n<p>\n 4. Vertex presentation</p>\n<p>\n 5. Ruptured membranes</p>\n<p>\n  </p>\n
      • principal_exclusion_criteria<p>\n 1. Patients on trial for vaginal delivery after cesarean section</p>\n<p>\n 2. Fetus with known congenital anomalies</p>\n<p>\n 3. Chorioamnionitis</p>\n<p>\n 4. Preeclampsia/Hemolysis Elevated Liver Enzymes Low Platelets (HELLP) syndrome</p>\n<p>\n 5. Suspected Small for Gestational Age (SGA)/Intra-uterine Growth Restriction (IUGR)</p>\n<p>\n 6. Stillbirth</p>\n<p>\n 7. Maternal pulmonary disease with O₂ saturation in labor < 95%</p>\n<p>\n 8. Any condition that precludes ROM or vaginal delivery (placenta praevia)</p>\n<p>\n 9. Malpresentation</p>\n<p>\n 10. Human Immunodeficiency Virus (HIV) disease</p>\n<p>\n 11. Multifetal gestation</p>\n<p>\n 12. Gestational Diabetes Mellitus (GDM)</p>\n<p>\n  </p>\n
      • primary_end_points<p>\n Recruitment of the desired sample size (100 patients).</p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety0
      • scope_efficacy1
      • 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_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n We will recruit one Research Coordinator and one Study Nurse for the study duration (about 8 months) </p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n The pulse oximeter device was developed in the United States which is where the sponsor is as well. Aga Khan university hospital, Nairobi was selected to undertake the initial study due to the vast research expertise of one of the co-PI (Prof Marleen Temmerman) and her keen interest in ensuring reduction in adverse perinatal outcomes. As part of advocacy, a novel device that can help improve neonatal survival would be a very useful addition to labour management hence the need for the trial. </p>\n<p>\n This will be an initial phase, which would be extended to multiple sites based on the results of this trial.  </p>\n
      • other_details_regulatory_notapproved<p>\n NACOSTI: October 2020</p>\n<p>\n Pan African Clinical Trials Registry</p>\n
      • other_details_regulatory_approved<p>\n None</p>\n
      • other_details_regulatory_rejected<p>\n n/a</p>\n
      • other_details_regulatory_halted<p>\n n/a</p>\n
      • estimated_duration8-12 months
      • design_controlled_randomisedNo
      • design_controlled_openYes
      • design_controlled_single_blindYes
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorFetal cardiotocograph
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaAga Khan University hospital
      • single_site_physical_addressThird parklands avenue
      • single_site_contact_personFelix Oindi
      • single_site_telephone0723499586
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_site100
      • total_participants_worldwide100
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultYes
      • population_elderlyNo
      • gender_female1
      • gender_male0
      • subjects_healthyNo
      • subjects_patientsNo
      • subjects_vulnerable_populationsYes
      • subjects_women_child_bearingNo
      • subjects_women_using_contraceptionNo
      • subjects_pregnant_womenYes
      • subjects_nursing_womenNo
      • subjects_emergency_situationNo
      • subjects_incapable_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_namen/a
      • investigator1_middle_name
      • investigator1_family_namen/a
      • investigator1_qualificationn/a
      • investigator1_professional_addressn/a
      • investigator1_telephonen/a
      • investigator1_emaildroindi@gmail.com
      • organisations_transferred_Yes
      • number_participants100
      • notification
      • approval_date10-02-2022
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted18-06-2021
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe responses provided for the Evaluators\' queries have been considered sufficient.
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2022-02-10 11:09:26
      • created2020-10-21 18:23:35
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id600
        • application_id952
        • given_nameFelix
        • middle_nameMwembi
        • family_nameOindi
        • qualificationMMed (Obs/Gyn)
        • professional_addressAga Khan University Hospital
        • telephone0723499586
        • emaildroindi@gmail.com
        • created2020-10-21 19:42:39
        • modified2021-06-18 06:41:12
    • SiteDetail(array)
      • 0(array)
        • id828
        • application_id952
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2020-10-21 19:42:39
        • modified2021-06-18 06:41:12
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id464
        • application_id952
        • sponsorAngeM Devices, Inc.
        • sponsor_typeOthers
        • contact_personDr. John Missanelli
        • address8810 Wainwright Road Wyndmoor, Pa., US, 19038
        • telephone_number+1-267-368-2292
        • fax_number
        • cell_number+1-267-368-2292
        • email_addressjmissanelligrob@aol.com
        • created2020-10-21 19:42:39
        • modified2021-06-18 06:41:12
  • 3(array)
    • Application(array)
      • id934
      • user_id612
      • trial_status_id5
      • abstract_of_study<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:216px;\">\n <p>\n <strong>Study description:</strong></p>\n </td>\n <td style=\"width:492px;\">\n <p>\n <strong><u>Hypothesis:</u></strong> Low-dose radiation therapy (LDRT) improves clinical, radiographic, and immune outcomes in hospitalized patients with covid-19 pneumonia and severe acute respiratory syndrome.</p>\n <p>\n This study investigates LDRT as a selectively localized anti-inflammatory treatment to induce focal suppression of pulmonary immuno-toxicity within viral pneumonia infiltrates in hospitalized patients with COVID19.</p>\n <p>\n  </p>\n <p>\n <strong><u>Study: </u></strong>Administration of low dose whole lung radiotherapy (LDRT) for the treatment of severe COVID 19 pneumonia in patients on or requiring mechanical ventilation</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:216px;\">\n <p>\n <strong>Objectives:</strong></p>\n </td>\n <td style=\"width:492px;\">\n <p>\n To investigate safety and feasibility (primary endpoint) of low dose whole-lung radiation therapy (LDRT) in critically-ill patients with COVID-19 pneumonia, and to explore secondary efficacy endpoints: (1) clinical, (2) respiratory, and (3) outcome</p>\n <p>\n <strong><u>Primary Objective:</u></strong></p>\n <ol>\n <li>\n To assess the feasibility and safety of administering LDRT to patients with severe Covid 19 pneumonia</li>\n <li>\n To assess the toxicity of a single dose of LDRT administered to patients with severe Covid 19 pneumonia</li>\n </ol>\n <p>\n <strong><u>Secondary Objective:</u></strong></p>\n <ol>\n <li>\n Improvement in oxygen requirement at 3 days following LDRT</li>\n <li>\n Ability to come off mechanical (or avoid mechanical) ventilation within 7 days following LDRT</li>\n <li>\n Discharge by 14d and 28d following LDRT</li>\n <li>\n Death by 14d and 28d following LDRT</li>\n </ol>\n </td>\n </tr>\n <tr>\n <td style=\"width:216px;\">\n <p>\n <strong>Endpoints</strong></p>\n </td>\n <td style=\"width:492px;\">\n <p>\n Primary</p>\n <ol>\n <li>\n Safety/Feasibility – ability to complete LDRT without treatment related SAE</li>\n <li>\n Toxicity – vital signs to assess clinical and respiratory status at 24h following LDRT</li>\n </ol>\n <p>\n Secondary</p>\n <ol>\n <li>\n Efficacy - ability to be weaned off pre-LDRT ventilatory or oxygen support at 3d post LDRT</li>\n <li>\n Efficacy – ability to come off (or avoid) ventilatory support at 7d post LDRT</li>\n </ol>\n <ol>\n <li value=\"3\">\n Efficacy - discharge or death by 14d / 28d post LDRT</li>\n </ol>\n </td>\n </tr>\n <tr>\n <td style=\"width:216px;\">\n <p>\n <strong>SAMPLE SIZE</strong></p>\n </td>\n <td style=\"width:492px;\">\n <p>\n Up to 20 participants will be enrolled on this study.</p>\n <ul>\n <li>\n Cohort 1 (pre-Vent): Up to 10 participants</li>\n <li>\n Cohort 2 (on-Vent): Up to 10 participants</li>\n </ul>\n </td>\n </tr>\n <tr>\n <td style=\"width:216px;\">\n <p>\n <strong>Study population</strong></p>\n </td>\n <td style=\"width:492px;\">\n <ol>\n <li>\n Patient with rtRTPC and Xray/CT proven Covid 19 pneumonia who have not responded to conventional therapy and:</li>\n </ol>\n <p style=\"margin-left:18.0pt;\">\n Cohort 1: would need mechanical ventilation if condition worsens (pre-Vent)</p>\n <p style=\"margin-left:18.0pt;\">\n Cohort 2: has been on mechanical ventilation, but for not more than 5 days (on-Vent)</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:216px;\">\n <p>\n <strong>Phase: </strong></p>\n </td>\n <td style=\"width:492px;\">\n <p>\n Pilot Phase 1b/2 study</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:216px;\">\n <p>\n <strong>Description of sites/facilities enrolling patients:</strong></p>\n </td>\n <td style=\"width:492px;\">\n <ol>\n <li>\n AKUHN – a collaborative effort of the Clinical Research Unit, dept. of hematology-oncology (radiation therapy section), infectious diseases, critical care</li>\n </ol>\n </td>\n </tr>\n <tr>\n <td style=\"width:216px;\">\n <p>\n <strong>Description of study intervention:</strong></p>\n </td>\n <td style=\"width:492px;\">\n <ol>\n <li>\n Single dose of 100 cGy LDRT administered to both lungs within 48h of determining eligibility</li>\n <li>\n Cohort 1 : 5 patients will be treated. If acute treatment related SAE is observed in ≤1 of 5 patients, additional 5 patients will be treated.</li>\n <li>\n Cohort 2 : 5 patients will be treated. If acute treatment related SAE is observed in ≤1 of 5 patients, additional 5 patients will be treated.</li>\n </ol>\n <p style=\"margin-left:18.0pt;\">\n If  > 1 of the initial 5 patients in either cohort experiences acute treatment related SAE, enrollment to that cohort will be halted.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:216px;\">\n <p>\n <strong>Study Duration:</strong></p>\n </td>\n <td style=\"width:492px;\">\n <p>\n 3 months</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:216px;\">\n <p>\n <strong>Participant duration:</strong></p>\n </td>\n <td style=\"width:492px;\">\n <p>\n 28d from enrollment</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • study_title<p>\n <strong>A pilot phase Ib/II study of whole-lung low dose radiation therapy (LDRT) in the treatment of severe Covid 19 pneumonia patients on (or requiring) mechanical ventilatory support</strong></p>\n
      • laymans_summary<p style=\"margin-left:50.2pt;\">\n This research study is designed to find out if low dose radiation therapy can be safely be administered to patient with severe Covid 19 pneumonia and if this can help improve outcomes in critically ill patients with COVID-19. It is believed radiation will help improve the excess inflammation in the lungs that occurs as a complication of COVID-19. The low dose radiation is much lower than is used in the treatment of other conditions and it is believed that it will  not have significant side effects, and the risk  will be much less than that of worsening Covid 19 pneumonia which can be life threatening. 20 subjects will participate in this study. Study site will be at Aga Khan University, Nairobi</p>\n
      • short_titleLOW DOSE RADIATION THERAPY
      • protocol_noECCT/20/08/04
      • version_no2
      • date_of_protocol24-08-2020
      • study_drugN/A
      • disease_conditionCOVID 19
      • 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_nameRadiotherapy
      • product_type_medical_device_name
      • comparatorNo
      • comparator_name
      • comparator_registered
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressstacey.gondi@aku.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_addendum0
      • 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_applicantStacey Gondi
      • declaration_date131-08-2020
      • declaration_principal_investigatorProf Mansoor Saleh
      • declaration_date231-08-2020
      • placebo_presentNo
      • study_objectives<h1>\n <span style=\"font-size:12px;\"><strong>Primary Objective</strong></span></h1>\n<ol>\n <li>\n To assess the feasibility and safety of administered LDRT to patients with severe Covid 19 pneumonia</li>\n <li>\n To assess the toxicity of a single dose of LDRT administered to patients with severe Covid 19 pneumonia</li>\n</ol>\n<h1>\n <span style=\"font-size:12px;\"><strong>Secondary Objectives</strong></span></h1>\n<ol>\n <li>\n Improvement in Oxygen requirement at 3 days following LDRT</li>\n <li>\n Ability to come off mechanical ventilation within 7 days following LDRT</li>\n <li>\n Discharge by 14d and 28d following LDRT</li>\n <li>\n Death by 14d and 28d following LDRT</li>\n</ol>\n
      • principal_inclusion_criteria<ol style=\"list-style-type:lower-alpha;\">\n <li>\n Be age 18 or over</li>\n <li>\n Have had a positive rtPCR test confirming the diagnosis of COVID-19 from nasopharyngeal swab, Sputum or lower respiratory tract sample</li>\n <li>\n Have had clinical signs of severe acute respiratory syndrome or pneumonia (dyspnea, cough, with need for oxygen support at the time of enrolment)</li>\n <li>\n Documented pO2 < 94% while on ambient air on admission, and requires supplemental oxygen to maintain pO2 ≥ 94%.</li>\n</ol>\n<ol>\n <li>\n Cohort 1: currently not on mechanical ventilation but would need mechanical ventilation if condition worsens (pre-Vent)</li>\n <li>\n Cohort 2: currently on mechanical ventilation for ≤ 5 days (on-Vent)</li>\n</ol>\n<ol style=\"list-style-type:lower-alpha;\">\n <li value=\"5\">\n Have visible consolidations/ground glass opacities on chest x-ray or computed tomography consisted with Covid 19 pneumonia.</li>\n <li value=\"6\">\n The patient, according to the treating physician, has received medical treatment considered best practice as per the institution’s guidelines, and does not show improvement</li>\n <li value=\"7\">\n Willingness and ability of the subject to comply with scheduled visits, protocol-specified laboratory tests, other study procedures, and study restrictions.</li>\n <li value=\"8\">\n Evidence of a signed informed consent/assent indicating that the subject is aware of the infectious nature of the disease and has been informed of the procedures to be followed, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation.</li>\n</ol>\n
      • principal_exclusion_criteria<ol style=\"list-style-type:lower-alpha;\">\n <li>\n Pre-existing lung comorbidity such as severe COPD, severe uncontrolled asthma or heart failure or concomitant active systemic infection.  </li>\n <li>\n Pre-existing dependency on supplemental oxygen prior to diagnosis of Covid 19 pneumonia</li>\n <li>\n Patients on mechanical ventilation requiring 100% FIO2 and > 8mm PEEP to maintain pO2 > 94% will not be eligible</li>\n <li>\n Unwilling or unable to following protocol procedures</li>\n <li>\n Pregnant and/or planned to be pregnant within in next 6 months</li>\n <li>\n Hemodynamic and Ventilatory instability precluding transfer to Radiation Oncology department</li>\n</ol>\n
      • primary_end_points<h1>\n  </h1>\n<ol>\n <li>\n Safety/Feasibility – % patients able to complete LDRT without treatment related SAE at 24h following LDRT</li>\n <li>\n Toxicity – % patients without worsening of vital signs to assess clinical and respiratory status at 24h following LDRT (CTCAE acute toxicity criteria)</li>\n</ol>\n<h1>\n  </h1>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy1
      • scope_safety1
      • scope_efficacy1
      • 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_exploratory1
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use0
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n <span style=\"font-family:times new roman,times,serif;\"><span style=\"font-size:12px;\">The Aga Khan University Hospital, Nairobi has a Clinical Research Unit (CRU) with specific focus in conducting ICH-GCP/FDA compliant Clinical Research. The CRU is well-staffed by trained personnel with expertise in the following research related tasks:</span></span></p>\n<ul>\n <li>\n <span style=\"font-family:times new roman,times,serif;\"><span style=\"font-size:12px;\">Clinical Research Nursing: Make CRF entries/resolve queries; Collect medical information; Vital signs; Collect adverse events; Administer IP; Collect lab samples; Participant recruitment and retention</span></span></li>\n <li>\n <span style=\"font-family:times new roman,times,serif;\"><span style=\"font-size:12px;\">Investigational Drug Services: Manage IP receipt/return; Prepare and dispense IP; Unblinding procedures</span></span></li>\n <li>\n <span style=\"font-family:times new roman,times,serif;\"><span style=\"font-size:12px;\">Regulatory Affairs: Maintain essential documents; Manage submissions to ethics and regulatory authorities</span></span></li>\n <li>\n <span style=\"font-family:times new roman,times,serif;\"><span style=\"font-size:12px;\">Contracts and Budgets: Maintain legal and financial documents; Ensure appropriate invoicing to the sponsor; Ensure appropriate processes for research covered procedures versus patients’ standard of care</span></span></li>\n <li>\n <span style=\"font-family:times new roman,times,serif;\"><span style=\"font-size:12px;\">Data Management: Make CRF entries/resolve queries; Maintain the patients’ research documents</span></span></li>\n <li>\n <span style=\"font-family:times new roman,times,serif;\"><span style=\"font-size:12px;\">Clinical Research operations: Oversight of AKU’s Clinical Research Unit’s studies and staff; support all research staff with their tasks</span></span></li>\n <li>\n <span style=\"font-family:times new roman,times,serif;\"><span style=\"font-size:12px;\">Investigator: Obtain Informed Consent; Assess eligibility; Make CRF entries/resolve Queries; Medical decisions/review; Collect medical information; Vital signs; Assess Ordinal Scale; Collect/Assess Adverse Events; Administer IP; Conduct Physical Exam; Collect Lab Samples; Maintain Essential Documents; IP processes</span></span></li>\n</ul>\n<p>\n  </p>\n<ul>\n <li>\n <span style=\"font-family:times new roman,times,serif;\"><span style=\"font-size:12px;\"><span class=\"ms-rtethemeforecolor-2-5\">The Aga Khan University Hospital, Nairobi is home to one of the most sophisticated radiology facilities in The Aga Khan University Hospital, Nairobi is home to one of the most sophisticated radiology facilities in East and Central Africa.<br />\n The Radiology Department provides a comprehensive range of imaging services, including both routine and specialized procedures.East and Central Africa.</span></span></span><span style=\"font-size:10.5pt;font-family:\"><o:p><span style=\"font-family:times new roman,times,serif;\"><span style=\"font-size:12px;\"> </span></span></o:p></span></li>\n</ul>\n<ul>\n <li>\n <p class=\"ms-rteelement-p\" style=\"margin: 0cm 0cm 7.5pt; text-align: justify; background-image: initial; background-position: initial; background-size: initial; background-repeat: initial; background-attachment: initial; background-origin: initial; background-clip: initial; box-sizing: content-box; outline: 0px;\">\n  </p>\n </li>\n</ul>\n
      • other_details_explanation<p>\n N/A</p>\n
      • other_details_regulatory_notapproved<p>\n NONE</p>\n
      • other_details_regulatory_approved<p>\n NONE</p>\n
      • other_details_regulatory_rejected<p>\n NONE</p>\n
      • other_details_regulatory_halted<p>\n NONE</p>\n
      • estimated_duration3 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_stateYes
      • location_of_areaAga Khan University Hospital, Nairobi
      • single_site_physical_addressAga Khan University Hospital Nairobi 3rd Parklands Avenue, off Limuru Road, P 0. Box 30270, GPO 00100, Nairobi, Kenya
      • single_site_contact_personProf. Mansoor Saleh
      • single_site_telephone+254 780 428 334
      • multiple_sites_member_stateNo
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_siteUP TO 20
      • total_participants_worldwideUP TO 20
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • 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_specifyPatients who cannot give consent will have their next of kin consent for them
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameN/A
      • investigator1_middle_name
      • investigator1_family_nameN/A
      • investigator1_qualificationN/A
      • investigator1_professional_addressN/A
      • investigator1_telephoneN/A
      • investigator1_emailmansoor.saleh@aku.edu
      • organisations_transferred_No
      • number_participantsUP TO 20
      • notification
      • approval_date11-11-2020
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted31-08-2020
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonApplication has been approved by the Expert Committee
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2022-08-01 11:18:35
      • created2020-08-30 21:21:47
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id578
        • application_id934
        • given_namePROF. MANSOOR
        • middle_name
        • family_nameSALEH
        • qualificationMD, Professor of Medicine and Pathology
        • professional_addressAga Khan University Hospital Nairobi 3rd Parklands Avenue, off Limuru Road, P 0. Box 30270, GPO 00100, Nairobi, Kenya
        • telephone0780428334
        • emailmansoor.saleh@aku.edu
        • created2020-08-30 21:45:11
        • modified2020-08-31 22:26:53
    • SiteDetail(array)
      • 0(array)
        • id806
        • application_id934
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2020-08-30 21:45:11
        • modified2020-08-31 22:26:53
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id451
        • application_id934
        • sponsorN/A
        • sponsor_typeResearch Institution
        • contact_person
        • addressN/A
        • telephone_numberN/A
        • fax_number
        • cell_numberN/A
        • email_addressmansoor.saleh@aku.edu
        • created2020-08-30 21:45:11
        • modified2020-08-31 22:26:53
  • 4(array)
    • Application(array)
      • id927
      • user_id559
      • trial_status_id7
      • abstract_of_study<p>\n The current World Health Organization (WHO) control strategy for Soil-Transmitted Helminths (STH) emphasizes morbidity control through mass drug administration with albendazole or mebendazole, mainly targeting pre-school and school-aged children in endemic areas. Increasing concerns have been raised about the success of these monotherapy strategies: 1) whilst albendazole is still efficacious against <em>Ascaris lumbricoides </em>and hookworm, a low and decreasing efficacy against <em>Trichuris trichiura </em>is observed, and none of these strategies is effective against <em>S. stercoralis</em>; 2) the use of widespread monotherapy could lead to the emergence of albendazole resistance. Modelling studies predict a huge impact on years lived with disability and economic productivity, if these strategies remain unchanged. Ivermectin has shown an enhanced activity against <em>T. trichiura </em>when combined with albendazole, and is considered the drug of choice against strongyloidiasis and other parasitic infections. Adding ivermectin to albendazole would increase efficacy of the interventions, and decrease the possibility of emergence of resistance, as recently suggested by WHO and the Bill and Melinda Gates Foundation reports.</p>\n<p>\n  </p>\n<p>\n The main goal of this project is to develop and test the safety and efficacy of a fixed-dose co-formulation of ivermectin and albendazole against STHs, as a single dose and a three-dose regimen, compared to a single dose of albendazole in a phase III clinical trial. The project will be conducted in schools in Kwale county along the shoreline of the Indian Ocean that has been shown to have high prevalence of <em>Trichiris trichiura</em>. The study population will be school aged children 5-15 years.</p>\n<p>\n  </p>\n<p>\n The project will include capacity building and networking activities. Besides microscopy-based procedures, parasite DNA detecting techniques (PCR) will be used and validated as markers of treatment response. Modelling studies will evaluate the potential impact on transmission and economic benefits of the new treatment regimen. The scientific results will be presented to the scientific community, local governments and other implementation actors and stakeholders. Previous collaborations of members of this consortium developed and tested the safety of a fixed high dose of ivermectin, as a first step towards the fixed- dose combination with albendazole. This consortium integrates complementary expertise in drug development, manufacture and expertise in drug development, manufacture and regulatory processes, expertise in parasitology, veterinary, epidemiology and public health.</p>\n
      • study_title<p align=\"center\">\n <strong>Evaluation of the effectiveness of IVERMECTIN co-formulation vs ALBENDAZOLE for treatment of </strong><strong>for the Treatment of Soil-Transmitted Helminth Infections (<em>Trichuris trichiura</em>, hookworm, <em>Strongyloides stercoralis</em>) in school aged children and Young Adult Subjects (ALIVE Study)</strong></p>\n
      • laymans_summary<p>\n <em>Lay title</em></p>\n<p>\n Evaluation of the effectiveness of IVERMECTIN co-formulation vs. ALBENDAZOLE for treatment of worms</p>\n<p>\n <em>Background</em></p>\n<p>\n Intestinal parasitic worm (STH) are common parasitic infections in Kenya, causing loss of blood and gastrointestinal problems and affecting how a child perfomes at school. The current World Health Organization (WHO) control strategy for worms emphasizes control of sickness cause by worms through mass deworming with albendazole or mebendazole, mainly  pre-school and school-aged children in areas where worms are found in Kenya. However, researchers have raised concerns about the success of these treatment of worms using single drugs as a low and ability of these drugs aganist against whipworms, and the possibilities that mass deworming could lead to the emergence of albendazole failure of the drugs to cure sicknes caused by the worms. Investigating the effectiveness of alternative drugs is important to ensure that these control mass deworming programmes are successful in achieving the target of controlling sickness causes by worms and eventually get rid of worminfection.</p>\n<p>\n <em>What questions are we trying to answer?</em></p>\n<p>\n We want to find out whether combining albendazole and ivermectin into a single drug will be more effective in treating of whipworm infection. The current drugs (albendazole and mebendazole) that are being used for the treatment of whipworm infections are not efficacious; therefore, many children remain infected. We also wish to find out if there is any resistance that can be identified to current deworming drugs that are being used.</p>\n<p>\n <em>Where is the study taking place, how many people does it involve and how are they selected?</em></p>\n<p>\n The study will take place in public primary schools whose village catchment areas are villages along the shores of the Indian Ocean in Kwale county. Approximately 800 children aged between 5-17 years attending one of the participating primary schools who have informed parental consent will be recruited into the study. Children will be selected to be part of the study based on willingness to be part of the research study and being infected with either hookworm, whipworm or threadworm.</p>\n<p>\n <em>What does the study involve for those who are taking part?</em></p>\n<p>\n At the beginning of the study, we will take a stool sample from the children to find out whether or not they are infected with worms. If children do not have worms or only have bilharzia, they will not be included in the study. Children who are infected with hookworm or whipworm or both will be recruited into the study. Once recruited, the children will be randomly assigned into one of the three study arms. Children will then be treated according to the treatment arm in which they were assigned. Twenty-one days after treatment, a stool sample will be collected to check for infection clearance. Study participants will be monitored by study doctors for 3h after treatment for adverse events that may have occurred as a result of treatment. Three and seven days after treatment, children will be revisited at the school premises for adverse event monitoring. In 100 childeren included in the first part of the study blood from a finger prick less than 1ml will be taken to conuct pharmacokinetics assessment at 4, 8, 24, 52 and 78 hours post treatment.</p>\n<p>\n <em>What are the risks and benefits involved in taking part?</em></p>\n<p>\n The drugs are known to show excellent safety profile except for those patients harbouring <em>Loa loa</em> infection(1). In recent studies, descriptions of little visual disturbance were observed. These events were reported to be mild, transient, and of short duration (a few minutes to a few hours). For this reason, in this study, subjects will be observed closely for any immediate risks after study drug administration. We do not think there will be any long-term effects on the participants. The use a combination of albendazole and ivermectin in the proposed combination therapy against STH could offer a solution to several disadvantages in the current strategy in terms of curing of whipworm infection. Participants may experience minor discomfort during the collection of finger-prick blood samples.</p>\n<p>\n <em>How will the study benefit society?</em></p>\n<p>\n The results from this study will offer insight for the effectiveness of a new combination of albendazole and ivermectin with great potential of improving the control of helminth worldwide, with emphasis on whipworms that are currently difficult to treat. Further this results, may increases the possibility of elimination of helminth with the possibility of a more effective drug. Millions of Africans living in areas where whipworm occurs may benefit.</p>\n<p>\n <em>When does the study start and finish?</em></p>\n<p>\n It is estimated that the study will take 18 months from recruitment (January 2021) until completion of data analyses (September 2022).</p>\n<p>\n  </p>\n
      • short_titleALIVE study
      • protocol_noECCT/20/08/02
      • version_noKenya Specific Protocol v1.7, 22nd May 2020
      • date_of_protocol06-08-2020
      • study_drugIVERMECTIN co-formulation vs. ALBENDAZOLE
      • disease_conditionSoil-Transmitted Helminth Infections
      • 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_nameIVERMECTIN co-formulation vs. ALBENDAZOLE
      • product_type_medical_device_name
      • comparatorYes
      • comparator_nameALBENDAZOLE
      • comparator_registeredYes
      • comparator_countries
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressstellakepha2005@yahoo.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_addendum0
      • 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_applicantCharles Mwandawiro
      • declaration_date117-08-2020
      • declaration_principal_investigatorCharles Mwandawiro
      • declaration_date217-08-2020
      • placebo_presentNo
      • study_objectives<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" style=\"width:633px;\" width=\"633\">\n <thead>\n <tr>\n <th style=\"width:312px;\">\n <p align=\"center\">\n OBJECTIVES</p>\n </th>\n <th style=\"width:321px;\">\n <p align=\"center\">\n ENDPOINTS</p>\n </th>\n </tr>\n <tr>\n <th style=\"width:312px;\">\n <p>\n Phase II componet</p>\n </th>\n <th style=\"width:321px;\">\n <p align=\"center\">\n  </p>\n </th>\n </tr>\n </thead>\n <tbody>\n <tr>\n <td style=\"width:312px;\">\n <p>\n Primary</p>\n </td>\n <td style=\"width:321px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:312px;\">\n <ol>\n <li>\n To evaluate the <strong>safety</strong> of the Fixed dose combination (FDC) as a single dose or three-dose regimen for the treatment of T. trichiura in paediatric and young adult population.</li>\n </ol>\n </td>\n <td style=\"width:321px;\">\n <ol>\n <li>\n Frequency, type, severity and relationship to study drug for all adverse events and severe adverse events for FDC and FDCx3 (safety).</li>\n </ol>\n </td>\n </tr>\n <tr>\n <td style=\"width:312px;height:21px;\">\n <p>\n Secondary</p>\n </td>\n <td style=\"width:321px;height:21px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:312px;\">\n <ol>\n <li>\n To describe the extent of ivermectin exposure in different weight strata.</li>\n <li>\n To evaluate the acceptability/palatability of the FDC 400mg-18mg and 400mg-9mg.</li>\n <li>\n .</li>\n </ol>\n </td>\n <td style=\"width:321px;\">\n <ol>\n <li>\n Measurement of the rate of absorption (Cmax), time to reach Cmax (Tmax) and extent of absorption (AUC) of the FDC and FDCx3.</li>\n </ol>\n <ol>\n <li>\n Participant acceptability and palatability evaluation of the FDC 400mg-18mg and 400mg-9mg using the 5 point Likert/numeric rating scale (NRS).</li>\n </ol>\n </td>\n </tr>\n <tr>\n <td style=\"width:312px;\">\n <p>\n Phase III componet</p>\n </td>\n <td style=\"width:321px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:312px;\">\n <p>\n Primary</p>\n </td>\n <td style=\"width:321px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:312px;\">\n <ol>\n <li>\n To evaluate the <strong>efficacy</strong> of the FDC as a single dose or 3-day single dose regimen compared to the standard single dose regimen of ALB (400 mg) for the treatment of T. trichiura in paediatric and young adult population.</li>\n </ol>\n </td>\n <td style=\"width:321px;\">\n <ol>\n <li>\n Cure rate (CR) for , <em>T. trichiura</em> 21 days after treatment as determined by microscopy (efficacy <em>T. trichiura</em>).</li>\n </ol>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:312px;\">\n <p>\n Secondary</p>\n </td>\n <td style=\"width:321px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:312px;\">\n <ol>\n <li>\n To evaluate the <strong>efficacy </strong>of the FDC as a single dose or 3-day single dose regimen for the treatment of hookworm and <em>S. stercoralis</em>.</li>\n <li>\n To evaluate the safety of the FDC as a single dose or 3-day dose regimen for the treatment of <em>T. trichiura</em>, hookworm and <em>S. stercoralis</em>.</li>\n <li>\n To evaluate the performance of PCR in calculating the primary outcome measurement (efficacy) compared to an egg counting method (Kato-Katz).To evaluate the frequency of known ALB resistant alleles in hookworm, <em>T. trichiura </em>and <em>S. stercoralis</em> in the three treatment arms before and after treatment.</li>\n </ol>\n </td>\n <td style=\"width:321px;\">\n <ol>\n <li>\n CR for hookworm and <em>S. stercoralis</em> 21 days after treatment, as determined by microscopy (efficacy hookworm and <em>S. stercoralis</em>).</li>\n <li>\n Egg reduction rate (ERR) for <em>T. trichiura</em> 21 days after treatment by microscopy.</li>\n <li>\n Frequency, type, severity and relationship to study drug for all adverse events and severe adverse events for ALB, FDC and FDCx3 (safety).</li>\n <li>\n CR for hookworm, <em>T. trichiura</em> and <em>S. stercoralis</em> using PCR.</li>\n <li>\n Parasite burden for hookworm, <em>T. trichiura </em>and <em>S. stercoralis</em> by PCR.</li>\n <li>\n Evaluation of genotypic albendazole resistance in the three arms.</li>\n </ol>\n </td>\n </tr>\n <tr>\n <td style=\"width:312px;\">\n <p>\n Exploratory</p>\n </td>\n <td style=\"width:321px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width:312px;\">\n <ol>\n <li>\n To assess the efficacy of the FDC against <em>A. lumbricoides</em> in co-infected participants compared to single dose ALB in participants co-infected with this STH.</li>\n <li>\n To describe the efficacy of the FDC in the prevalence of scabies compared to single dose ALB 400 mg.</li>\n <li>\n To evaluate the <strong>efficacy</strong> of the FDC in co-infected participants compared to single dose ALB in participants co-infected with STH.</li>\n </ol>\n </td>\n <td style=\"width:321px;\">\n <ol>\n <li>\n CR and ERR for <em>A. lumbricoides</em> in co-infected participants.</li>\n </ol>\n <ol>\n <li>\n Prevalence of scabies before and after treatment administration of ALB, FDC and FDCx3.</li>\n </ol>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • principal_inclusion_criteria<p>\n Specific Phase II/Phase III</p>\n<ol>\n <li>\n Phase II: Positive infection test by microscopy for <em>T. trichiura</em></li>\n <li>\n Phase III: Positive infection test by microscopy for at least one of the following STH: <em>T. trichiura</em> hookworms, and/or larvae of <em>S. stercoralis</em>.</li>\n</ol>\n<p>\n To be applied to Phase II and Phase III</p>\n<ol>\n <li>\n Weight ≥15 Kg.</li>\n <li>\n Male or female, aged 5 to 18 years.</li>\n <li>\n Female subjects who are ≥12 years old must have a negative urine pregnancy test at screening or at the time of randomization.</li>\n <li>\n Ability to take oral medication, willingness to comply with all study procedures.</li>\n <li>\n Parental acceptance to participate in the study by obtaining a signed and dated informed consent form approved by the Regulatory authorities. Verbal assent will also be obtained from children aged 12–18 years.</li>\n</ol>\n
      • principal_exclusion_criteria<ol>\n <li>\n Intake of ALB, mebendazole and/or IVM or any potentially interacting drug three months prior to the time of randomisation within the previous 3 months before screening.</li>\n <li>\n Residence outside the study area or planning to move away in the four weeks following recruitment.</li>\n <li>\n Epidemiological risk of <em>Loa loa</em> infection.</li>\n <li>\n Serious medical illness, per investigator’s criteria.</li>\n <li>\n Any participant’s condition preventing from the appropriate evaluation and follow-up, as per investigator’s criteria.</li>\n <li>\n Known hypersensitivity to any component of either study treatment.</li>\n <li>\n Positive urine test, pregnant or first week post-partum.</li>\n</ol>\n
      • primary_end_points<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" style=\"width: 633px;\" width=\"633\">\n <thead>\n <tr>\n <th style=\"width: 312px;\">\n <p align=\"center\">\n OBJECTIVES</p>\n </th>\n <th style=\"width: 321px;\">\n <p align=\"center\">\n ENDPOINTS</p>\n </th>\n </tr>\n <tr>\n <th style=\"width: 312px;\">\n <p>\n Phase II componet</p>\n </th>\n <th style=\"width: 321px;\">\n <p align=\"center\">\n  </p>\n </th>\n </tr>\n </thead>\n <tbody>\n <tr>\n <td style=\"width: 312px;\">\n <p>\n Primary</p>\n </td>\n <td style=\"width: 321px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 312px;\">\n <ol>\n <li>\n To evaluate the <strong>safety</strong> of the Fixed dose combination (FDC) as a single dose or three-dose regimen for the treatment of T. trichiura in paediatric and young adult population.</li>\n </ol>\n </td>\n <td style=\"width: 321px;\">\n <ol>\n <li>\n Frequency, type, severity and relationship to study drug for all adverse events and severe adverse events for FDC and FDCx3 (safety).</li>\n </ol>\n </td>\n </tr>\n <tr>\n <td style=\"width: 312px; height: 21px;\">\n <p>\n Secondary</p>\n </td>\n <td style=\"width: 321px; height: 21px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 312px;\">\n <ol>\n <li>\n To describe the extent of ivermectin exposure in different weight strata.</li>\n <li>\n To evaluate the acceptability/palatability of the FDC 400mg-18mg and 400mg-9mg.</li>\n <li>\n .</li>\n </ol>\n </td>\n <td style=\"width: 321px;\">\n <ol>\n <li>\n Measurement of the rate of absorption (Cmax), time to reach Cmax (Tmax) and extent of absorption (AUC) of the FDC and FDCx3.</li>\n </ol>\n <ol>\n <li>\n Participant acceptability and palatability evaluation of the FDC 400mg-18mg and 400mg-9mg using the 5 point Likert/numeric rating scale (NRS).</li>\n </ol>\n </td>\n </tr>\n <tr>\n <td style=\"width: 312px;\">\n <p>\n Phase III componet</p>\n </td>\n <td style=\"width: 321px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 312px;\">\n <p>\n Primary</p>\n </td>\n <td style=\"width: 321px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 312px;\">\n <ol>\n <li>\n To evaluate the <strong>efficacy</strong> of the FDC as a single dose or 3-day single dose regimen compared to the standard single dose regimen of ALB (400 mg) for the treatment of T. trichiura in paediatric and young adult population.</li>\n </ol>\n </td>\n <td style=\"width: 321px;\">\n <ol>\n <li>\n Cure rate (CR) for , <em>T. trichiura</em> 21 days after treatment as determined by microscopy (efficacy <em>T. trichiura</em>).</li>\n </ol>\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 312px;\">\n <p>\n Secondary</p>\n </td>\n <td style=\"width: 321px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 312px;\">\n <ol>\n <li>\n To evaluate the <strong>efficacy </strong>of the FDC as a single dose or 3-day single dose regimen for the treatment of hookworm and <em>S. stercoralis</em>.</li>\n <li>\n To evaluate the safety of the FDC as a single dose or 3-day dose regimen for the treatment of <em>T. trichiura</em>, hookworm and <em>S. stercoralis</em>.</li>\n <li>\n To evaluate the performance of PCR in calculating the primary outcome measurement (efficacy) compared to an egg counting method (Kato-Katz).To evaluate the frequency of known ALB resistant alleles in hookworm, <em>T. trichiura </em>and <em>S. stercoralis</em> in the three treatment arms before and after treatment.</li>\n </ol>\n </td>\n <td style=\"width: 321px;\">\n <ol>\n <li>\n CR for hookworm and <em>S. stercoralis</em> 21 days after treatment, as determined by microscopy (efficacy hookworm and <em>S. stercoralis</em>).</li>\n <li>\n Egg reduction rate (ERR) for <em>T. trichiura</em> 21 days after treatment by microscopy.</li>\n <li>\n Frequency, type, severity and relationship to study drug for all adverse events and severe adverse events for ALB, FDC and FDCx3 (safety).</li>\n <li>\n CR for hookworm, <em>T. trichiura</em> and <em>S. stercoralis</em> using PCR.</li>\n <li>\n Parasite burden for hookworm, <em>T. trichiura </em>and <em>S. stercoralis</em> by PCR.</li>\n <li>\n Evaluation of genotypic albendazole resistance in the three arms.</li>\n </ol>\n </td>\n </tr>\n <tr>\n <td style=\"width: 312px;\">\n <p>\n Exploratory</p>\n </td>\n <td style=\"width: 321px;\">\n <p>\n  </p>\n </td>\n </tr>\n <tr>\n <td style=\"width: 312px;\">\n <ol>\n <li>\n To assess the efficacy of the FDC against <em>A. lumbricoides</em> in co-infected participants compared to single dose ALB in participants co-infected with this STH.</li>\n <li>\n To describe the efficacy of the FDC in the prevalence of scabies compared to single dose ALB 400 mg.</li>\n <li>\n To evaluate the <strong>efficacy</strong> of the FDC in co-infected participants compared to single dose ALB in participants co-infected with STH.</li>\n </ol>\n </td>\n <td style=\"width: 321px;\">\n <ol>\n <li>\n CR and ERR for <em>A. lumbricoides</em> in co-infected participants.</li>\n </ol>\n <ol>\n <li>\n Prevalence of scabies before and after treatment administration of ALB, FDC and FDCx3.</li>\n </ol>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic1
      • 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_exploratory1
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n This study will be conducted in primary and secondary schools in Ethiopia, Kenya and Mozambique.</p>\n<p>\n Kenya (phase II and III components)</p>\n<p>\n The study will take place in Kwale county situated on the South coast of Kenya. It borders Tanzania to the South west, Taita taveta County to the West. The total area of the county is approximately 8,270 Km2 with a population of about 760,897.  The southern region of the county is on the shoreline of the Indian Ocean. The county is divided into four sub-counties, twenty wards (and thirty-four (34) locations. The county has 357 public primary schools (class 1-8). Stool and urine sample will be processed at the KEMR-Kwale laboratory.</p>\n<p>\n Ethiopia (phase III component only)</p>\n<p>\n The study will be conducted in the Bahir Dar Zurya woreda (district) in the West Gojam zone of the Amhara region which has an area of 1,443.37 Km2, and a population of 230,000. The district has 36 primary (grade 1 to 8) and 6 secondary (grade 9 and 10) schools. The total number of student population is 49,013 with an average of 1,160 students in each school. Stool and urine samples will be processed at the BDU laboratory by competent laboratory technicians.</p>\n<p>\n Mozambique (phase III component only)</p>\n<p>\n The study will be conducted in the Manhiça district in Southern Mozambique, a peri-urban setting with a predominantly young population. The site runs a Demographic Surveillance System in the area which covers the entire district, with a population of ≈204,000 inhabitants under surveillance, 44% of which are <15 years of age. Every household from the study area is geo-localised with an identification number.  The district has 93 primary and 9 secondary schools with a total student population of 72,829. Stool and urine samples will be processed at the FM-CISM laboratory by competent laboratory technicians.</p>\n<p>\n  </p>\n<p>\n At all sites, community sensitization will be conducted in the villages where the school children live by community health workers. Only children with informed consent and assent will be screened for eligibility and those who are eligible will be enrolled into the study</p>\n
      • other_details_explanation<p>\n The STOP the consortium is coordinated by the <strong>Barcelona Institute for Global Health (ISGlobal)</strong>, in Spain. The institute has greatly contributed to the translation of health research into public health policies, specially, in the fields of NTDs such as Chagas and Yaws disease as well as in Malaria. ISGlobal will coordinate the execution of the Clinical Trial in three sub-Saharan research centres:</p>\n<p>\n 1) The <strong>Centro de Investigação em Saúde da Manhiça (CISM)/Fundação Manhiça (FM) (Mozambique) </strong>has an excellence track record conducting clinical trials with high international standards, and has strong international partnerships, including with the EDCTP Network of Excellence TESA (Trials of Excellence in Southern Africa). Moreover, CISM has a state-of-the-art molecular biology laboratory and the WP5 leader has extensive experience with the performance of molecular diagnostics.</p>\n<p>\n 2) <strong>Bahir Dar University (Ethiopia) </strong>is a public university with a vision of becoming one of the ten premier research universities in Africa.</p>\n<p>\n 3) <strong>Kenyan Medical Research Institute (KEMRI) </strong>is one of the leading institutions in sub-Saharan Africa conducting integrated epidemiological, social, laboratory and clinical research in parallel, with results feeding into local and international health policy. The research facilities in KEMRI include state-of-the-art laboratories, including molecular biology expertise.</p>\n
      • other_details_regulatory_notapproved<p>\n N/A</p>\n
      • other_details_regulatory_approved<p>\n 1) The Centro de Investigação em Saúde da Manhiça (CISM)/Fundação Manhiça (FM) (Mozambique) review Board, submitted awaiting feedback</p>\n<p>\n 2) Bahir Dar University (Ethiopia<strong>) </strong>is a public university with a vision of becoming one of the ten premier research universities in Africa<strong> s</strong>ubmitted awaiting feedbacl</p>\n<p>\n  </p>\n
      • other_details_regulatory_rejected
      • other_details_regulatory_halted
      • estimated_duration1 year
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindYes
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorRegistered Albendazole
      • design_controlled_other_medicinalYes
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherNo
      • design_controlled_medicinal_specify
      • single_site_member_stateYes
      • location_of_areaKwale
      • single_site_physical_addressMsambweni, Lunga Lunga
      • single_site_contact_personStella kepha
      • single_site_telephone0721 831303
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states2
      • number_of_sites
      • multi_country_listEthiopia and Mozambique
      • data_monitoring_committeeYes
      • total_enrolment_per_site527
      • total_participants_worldwide1223
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenYes
      • population_adolescentYes
      • population_above_18No
      • population_adultNo
      • population_elderlyNo
      • gender_female1
      • gender_male1
      • subjects_healthyYes
      • 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_nameStella
      • investigator1_middle_name
      • investigator1_family_nameKepha
      • investigator1_qualificationPhD
      • investigator1_professional_addressKENYA MEDICAL RESEARCH INSTITUTE, Mbagathi Road, P.O. Box 54840, Nairobi, KENYA
      • investigator1_telephone+254-20-2722541
      • investigator1_emailstellakepha2005@yahoo.com
      • organisations_transferred_Yes
      • number_participants126 in Phase II\n401 Phase III\n
      • notification<p>\n N/A</p>\n
      • approval_date12-01-2021
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted17-08-2020
      • 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 style=\"font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; margin: 0px; font-stretch: normal; font-size: 16px; line-height: normal; color: rgb(23, 26, 29); outline: none !important;\">\n <span style=\"outline: none !important;\">Among 1001 </span><span style=\"outline: none !important;\">participants, 636 (63·5%) were infected with </span><span style=\"font-style: italic; outline: none !important;\">T. trichiura</span><span style=\"outline: none !important;\">, 360 (36·0%) with hookworm, and 104 (10·4%) with </span><span style=\"font-style: italic; outline: none !important;\">S. stercoralis</span><span style=\"outline: none !important;\">. A total of 243 </span>participants were allocated to the ALB arm, 381 to the FDCx1, and 377 to the</p>\n<p style=\"font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; margin: 0px; font-stretch: normal; font-size: 16px; line-height: normal; color: rgb(23, 26, 29); outline: none !important;\">\n <span style=\"outline: none !important;\">FDCx3· In both Phase II and III, gastrointestinal symptoms were the most common </span>mild-to-moderate adverse events (AEs) in FDC groups, being resolved within 48 <span style=\"outline: none !important;\">hours without intervention. No serious AEs occurred. For </span><span style=\"font-style: italic; outline: none !important;\">T. trichiura</span><span style=\"outline: none !important;\">, FDCx3 and FDCx1 showed higher CR (97·2% and 82·9%, </span>respectively) than ALB (35·9%). For hookworms, FDCx3 showed a superior CR (95·0%)</p>\n<p style=\"font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; margin: 0px; font-stretch: normal; font-size: 16px; line-height: normal; color: rgb(23, 26, 29); outline: none !important;\">\n <span style=\"outline: none !important;\">than ALB (65·1%), while FDCx1 had a similar CR (79·8%) to ALB. The sample size </span><span style=\"outline: none !important;\">for efficacy evaluation of </span><span style=\"font-style: italic; outline: none !important;\">S. stercoralis</span></p>\n<p style=\"font-family: "Helvetica Neue", Helvetica, Arial, sans-serif; margin: 0px; font-stretch: normal; font-size: 16px; line-height: normal; color: rgb(23, 26, 29); outline: none !important;\">\n <span style=\"outline: none !important;\">was not met.</span></p>\n
      • implication_results<div>\n This Phase II/III study met its primary objectives of demonstrating safety (Phase II) and efficacy (Phase III) of FDC in the enrolled pediatric populations:</div>\n<div>\n ï‚· FDC is more effective for curing T. trichiura infections than ALB, as shown by the significantly higher CRs compared with ALB, and supported by the secondary efficacy endpoint result of significantly higher T. trichiura ERRs compared with ALB.</div>\n<div>\n ï‚· Both of the FDC administration schedules are considered viable dosing strategies, as shown by significantly higher T. trichiura CRs with both the FDC Single Dose and FDC x3 compared with ALB.</div>\n<div>\n ï‚· FDC x3 is more effective for curing hookworm infection than ALB.</div>\n<div>\n ï‚· The efficacy of FDC for curing S. stercoralis was considered inconclusive due to the small sample size of participants positive for this STH.</div>\n<div>\n ï‚· Results of the PPK analysis indicate that the FDC single dose and FDC x3 dosing regimens are adequate for participants over or under 30 kg.</div>\n<div>\n ï‚· FDC single dose and FDC x3 are safe in pediatric populations, as shown by no serious TEAEs and only mild or moderate TEAEs.</div>\n
      • quantity_imported3400
      • quantity_dispensed1116
      • quantity_destroyed2284
      • quantity_exported0
      • balance_site0
      • final_date0000-00-00
      • modified2024-03-25 17:10:18
      • created2020-08-06 14:15:10
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id573
        • application_id927
        • given_nameCharles
        • middle_name
        • family_nameMwandawiro
        • qualificationPhD
        • professional_addressKENYA MEDICAL RESEARCH INSTITUTE, Mbagathi Road, P.O. Box 54840, Nairobi, KENYA
        • telephone+254-20-2722541
        • emailcmwandawiro@kemri.org
        • created2020-08-06 14:45:07
        • modified2020-08-17 18:26:51
    • SiteDetail(array)
      • 0(array)
        • id802
        • application_id927
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2020-08-06 14:45:07
        • modified2020-08-17 18:26:51
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id447
        • application_id927
        • sponsorBARCELONA INSTITUTE FOR GLOBAL HEALTH FOUNDATION
        • sponsor_typeResearch Institution
        • contact_personDr. Nana Aba Williams
        • addressBarcelona (08036), Rosselló, 132
        • telephone_number0034 932275400
        • fax_number
        • cell_number0034 932275400
        • email_addressnana.williams@isglobal.org
        • created2020-08-06 14:45:07
        • modified2020-08-17 18:26:51
• page_options(array)
  • 55
  • 1010
• redir
• $request->data(array)
  • Application(array)
    • trial_therapeutic_exploratory1
• $this->validationErrors(array)
  • Permission(empty)
  • Aro(empty)
  • Aco(empty)
  • Application(empty)
  • User(empty)
  • TrialStatus(empty)
  • InvestigatorContact(empty)
  • Sponsor(empty)
  • SiteDetail(empty)
  • County(empty)
• Loaded Helpers(array)
  • 0Html
  • 1Form
  • 2Session
  • 3Text
  • 4Number
  • 5SimpleGraph
  • 6Paginator
  • 7DebugTimer
  • 8Toolbar
  • 9HtmlToolbar

App Constants

CakePHP Constants

PHP Environment

Included Files

Include Paths

• 0/var/www/html/ctr/app/Plugin/Media/Lib/mm/src
• 1/var/www/html/ctr/lib
• 3/usr/share/php
• 4-> /var/www/html/ctr/lib/Cake/

Included Files

• core(array)
  • Behavior(array)
    • 0CORE/Model/Behavior/TreeBehavior.php
    • 1CORE/Model/Behavior/ContainableBehavior.php
    • 2CORE/Model/Behavior/AclBehavior.php
  • Cache(array)
    • 0CORE/Cache/Cache.php
    • 1CORE/Cache/Engine/FileEngine.php
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  • Component(array)
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    • 3CORE/Controller/Component/AuthComponent.php
    • 4CORE/Controller/Component/RequestHandlerComponent.php
    • 5CORE/Controller/Component/SessionComponent.php
    • 6CORE/Controller/Component/PaginatorComponent.php
  • Config(array)
    • 0CORE/Config/routes.php
    • 1CORE/Config/config.php
  • Controller(array)
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    • 1CORE/Controller/ComponentCollection.php
    • 2CORE/Controller/Component.php
  • Datasource(array)
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    • 3CORE/Model/Datasource/DataSource.php
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    • 1CORE/Error/ErrorHandler.php
  • I18n(array)
    • 0CORE/I18n/I18n.php
    • 1CORE/I18n/L10n.php
  • Log(array)
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    • 1CORE/Log/LogEngineCollection.php
    • 2CORE/Log/Engine/FileLog.php
    • 3CORE/Log/Engine/BaseLog.php
    • 4CORE/Log/CakeLogInterface.php
  • Model(array)
    • 0CORE/Model/ConnectionManager.php
    • 1CORE/Model/Permission.php
    • 2CORE/Model/Model.php
    • 3CORE/Model/BehaviorCollection.php
    • 4CORE/Model/Aro.php
    • 5CORE/Model/AclNode.php
    • 6CORE/Model/Aco.php
    • 7CORE/Model/ModelBehavior.php
  • Network(array)
    • 0CORE/Network/CakeRequest.php
    • 1CORE/Network/CakeResponse.php
  • Other(array)
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    • 1CORE/basics.php
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    • 3CORE/Core/Configure.php
    • 4CORE/Core/CakePlugin.php
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    • 6CORE/Event/CakeEvent.php
    • 7CORE/Event/CakeEventManager.php
    • 8CORE/Core/Object.php
  • Routing(array)
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    • 2CORE/Routing/DispatcherFilter.php
    • 3CORE/Routing/Filter/CacheDispatcher.php
    • 4CORE/Routing/Router.php
    • 5CORE/Routing/Route/CakeRoute.php
    • 6CORE/Routing/Route/PluginShortRoute.php
  • Utility(array)
    • 0CORE/Utility/Hash.php
    • 1CORE/Utility/Inflector.php
    • 2CORE/Utility/ObjectCollection.php
    • 3CORE/Utility/Debugger.php
    • 4CORE/Utility/String.php
    • 5CORE/Utility/ClassRegistry.php
    • 6CORE/Utility/Set.php
    • 7CORE/Utility/Sanitize.php
  • View(array)
    • 0CORE/View/HelperCollection.php
• app(array)
  • Behavior(array)
    • 0APP/Model/Behavior/SoftDeleteBehavior.php
  • Config(array)
    • 0APP/Config/core.php
    • 1APP/Config/bootstrap.php
    • 2APP/Config/routes.php
    • 3APP/Config/database.php
  • Controller(array)
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    • 1APP/Controller/AppController.php
  • Model(array)
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    • 4APP/Model/InvestigatorContact.php
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    • 6APP/Model/SiteDetail.php
    • 7APP/Model/County.php
  • Other(array)
    • 0APP/webroot/index.php
• plugins(array)
  • CakePdf(array)
    • Config(array)
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      • 1CakePdf/Config/routes.php
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    • Plugin(array)
      • 0CakeResque/Lib/CakeResque.php
      • 1CakeResque/vendor/kamisama/php-resque-ex/lib/Resque.php
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      • 8DebugKit/Lib/Log/Engine/DebugKitLog.php
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      • 10DebugKit/Lib/Panel/EnvironmentPanel.php
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      • 12DebugKit/Lib/DebugTimer.php
  • Media(array)
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    • Plugin(array)
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      • 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)
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    • Behavior(array)
      • 0Search/Model/Behavior/SearchableBehavior.php
  • Shim(array)
    • Config(array)
      • 0Shim/Config/bootstrap.php
  • Tools(array)
    • Config(array)
      • 0Tools/Config/bootstrap.php