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• applications(array)
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    • Application(array)
      • id1460
      • user_id692
      • trial_status_id(null)
      • abstract_of_study<p style=\"text-align: justify;\">\n Men who have sex with men (MSM) are at high risk for gonorrhoea and chlamydia in Kenya, where nucleic acid amplification testing (NAAT) is not feasible, and most infections therefore go undiagnosed. In 2011, the WHO recommended periodic presumptive treatment (PPT) of Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) infections for MSM at high risk for HIV acquisition due to condomless anal intercourse with multiple sex partners or a recent STI exposure. More recently, trials in well-resourced settings have demonstrated the efficacy of doxycycline post-exposure prophylaxis (doxyPEP) for reducing NG, CT, and syphilis infections among high-risk MSM. The goal of this study is to evaluate the impact and cost-effectiveness of WHO-recommended PPT versus doxyPEP compared to standard syndromic treatment among Kenyan MSM. This study aims to (1) evaluate the effectiveness and impact on antimicrobial resistance in NG of WHO-recommended PPT given every 3 months and of doxy-PEP taken 24-72 hours after condomless sex for reducing STI burden among Kenyan MSM; (2) assess the acceptability, feasibility, and safety of implementing WHO-recommended PPT and doxy-PEP compared to standard care among providers and patients; and (3) model the health and economic impact of scaling up WHO-recommended STI PPT and doxyPEP compared to standard of care on STI control among MSM and their partners in Kenya. We will conduct an open-label randomized trial with 2900 participants to evaluate these two interventions versus standard care assigned in a 2:2:1 ratio, with 18 months of follow-up at three MSM-friendly research clinics in Kenya. Results will inform parameters to update a stochastic model of STI transmission and cost-effectiveness analysis to project the impact of scaled-up STI PPT and doxyPEP in Kenya. This work will provide the critical data needed to inform guidelines and improve STI control among this key population in sub-Saharan Africa and other resource-limited settings.</p>\n
      • study_title<p>\n WHO-Recommended Periodic Presumptive Treatment versus Doxycycline Post-Exposure Prophylaxis for STI Control among Cisgender Men Who Have Sex with Men in Kenya.</p>\n
      • laymans_summary<p>\n 1. Why should you do this study?</p>\n<p>\n We are conducting this study to test two different interventions to improve sexually transmitted infection (STI) control among gay, bisexual, and other men who have sex with men (GBMSM) in Kenya. GBMSM have a high burden of STI that mostly are detected by expensive laborotory tests that are not available in public hospitals.</p>\n<p>\n 2. What questions are we trying to answer?</p>\n<p>\n One intervention that may reduce STIs among GBMSM is periodic presumptive treatment (PPT), in which one is treated every 3 months for STI regardless of symptoms. STI PPT has been recommended by the World Health Organization for GBMSM but never tested in a randomized trial. The other intervention is called doxyPEP, which consists of taking a medication called doxycycline 24-72 hours after you have condomless sex, as post-exposure prophylaxis (PEP) to prevent STI. DoxyPEP has been found to reduce STI among GBMSM in the United States and France but has not been tested among GBMSM in sub-Saharan Africa. No one knows if STI PPT or DoxyPEP is better at reducing STI among GBMSM in Kenya and similar settings.</p>\n<p>\n 3. Where is the study taking place?</p>\n<p>\n In 3 friendly GBMSM study sites in Kisumu, Nairobi, and Mombasa.</p>\n<p>\n 4. How many participants does it involve? We will enroll 2900 GBMSM participants. In addition up to 60 study staff will provide feedback on the two interventions.</p>\n<p>\n 5. How will they be selected?</p>\n<p>\n GBMSM participants will be engaged and screened for eligibility at community-based organizations at each of the three study sites. Participants need to be between 18-29 years, report condomless anal intercourse with a man in the past 6 months, multiple partners or a partner with a STI. They need to be willing to follow study procedures and remain in the study area for 18 months. GBMSM will be excluded if they are unable to understand the study purpose and procedures despite a thorough explanation by and discussion with the study team, are allergic to any of the antibiotics used, have used antibiotics for 14 days or more in the month before enrolment, or are taking medications that impact any of the antibiotics used.</p>\n<p>\n 6. What does the study involve for those taking part?</p>\n<p>\n Participants will be randomised to one of the following three groups: PPT, doxyPEP or standard of care. They will make seven quarterly research visits during the study, for 18 months from enrolment. At each visit, a clinician will collect 2 throat swabs, 2 rectal swabs, urine, and blood from each participant. Blood will be tested for syphilis and, if there is an infection, participants will be treated according to standard of care as soon as results are available. The swab and urine samples will be tested for gonorrhea and chlamydia at the end of the study, to determine which intervention worked best to reduce STI. At each visit a small hair sample will also be collected to measure antibiotic use in all participants. Additonally, a digital fingerprint will be taken to allow us to confirm partcipant’s identity at study visits without using a name or other identifiers. We will also collect a brief survey lasting 50-60 minutes on a tablet computer. This survey will include questions about sexual behavior, STI symptoms, and bioc use, substance use, and mental health.</p>\n<p>\n 7. What are the risks and benefits of taking part?</p>\n<p>\n 6 Version 1.1, dated 10 June 2024 There is a small risk of loss of privacy. For participants assigned to the intervention groups there is risk of medication side effects. Participants may benefit from regular physical exams, free syphilis testing, and counselling about STI prevention.</p>\n<p>\n 8. How will the study benefit society?</p>\n<p>\n The burden of STI among GBMSM and their sexual partners in Kenya may be reduced through the outcomes of this study. This is a contribution to science and will help inform health policy for GBMSM in Kenya and similar resource-limited settings.</p>\n<p>\n 9. When does the study start and finish?</p>\n<p>\n The study will likely start in the second half of 2024 and follow patients over 3 years (through June 2027), followed by testing of samples for chlamydia and gonorrhea and for antibiotic resistance in gonorrhea, as well as modeling and cost-effectiveness evaluations to inform scale-up, should either intervention prove to be more effective than standard care</p>\n
      • short_titleWHO PPT vs DPEP FOR STI IN MSM
      • protocol_noECCT/24/09/03
      • version_no1.1
      • date_of_protocol10-06-2024
      • study_drugDoxycycline Hyclate
      • disease_conditionChlamydia, Gonorrhea and Syphilis
      • 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_nameDoxylag
      • product_type_medical_device_name
      • comparatorYes
      • comparator_nameZetro (Azithromycin) and Orcef (Cefixime)
      • comparator_registeredYes
      • comparator_countriesKenya
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressfrao@uw.edu
      • applicant_covering_letter1
      • applicant_protocol1
      • applicant_patient_information1
      • applicant_investigators_brochure1
      • applicant_investigators_cv1
      • applicant_signed_declaration1
      • applicant_financial_declaration1
      • applicant_gmp_certificate1
      • applicant_indemnity_cover1
      • applicant_opinion_letter1
      • applicant_approval_letter1
      • applicant_statement1
      • applicant_participating_countries(null)
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd1
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      • applicant_stability_data1
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      • applicant_pictorial_sample1
      • applicant_gcp_training1
      • applicant_dsmb_charter1
      • applicant_detailed_budget1
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      • applicant_practice_license1
      • applicant_registration_ctr(null)
      • applicant_pan_african1
      • applicant_hard_copies(null)
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      • statistical_analysis_plan1
      • applicant_contractual_agreement1
      • declaration_applicantFatma Mwidadi
      • declaration_date123-09-2024
      • declaration_principal_investigatorSusan Graham
      • declaration_date223-09-2024
      • placebo_presentNo
      • study_objectives<p>\n Objective 1. To evaluate the effectiveness and impact on AMR in NG of two interventions: WHO-recommended PPT given every 3 months and doxy-PEP taken 24-72 hours after condomless sex, compared to standard syndromic treatment, for reducing STI burden among Kenyan MSM.</p>\n<p>\n Objective 2. To assess the acceptability, feasibility, and safety of implementing WHO-recommended PPT and doxy-PEP compared to standard care among providers and patients.</p>\n<p>\n Objective 3. To model the health and economic impact of scaling up WHO-recommended STI PPT and doxyPEP compared to standard of care on STI control among MSM and their partners in Kenya.</p>\n<p>\n  </p>\n
      • principal_inclusion_criteria<p>\n <strong>Trial Participants</strong></p>\n<p>\n 1. 18-29 years old</p>\n<p>\n 2. Assigned male sex at birth</p>\n<p>\n 3. Identifies as male (cis-gender)</p>\n<p>\n 4. Reports condomless anal intercourse with a man in the past 6 months</p>\n<p>\n 5. Reports multiple male sex partners OR a male sex partner with a syndromic (urethritis, proctitis, or genital ulcer disease) or laboratory-diagnosed sexually transmitted infection in the past 6 months</p>\n<p>\n 6. Willing and able to provide written informed consent and participate in all study procedures</p>\n<p>\n 7. Planning to remain in the study area for 18 months</p>\n<p>\n <strong>Study Staff</strong></p>\n<p>\n 1. 18 years of age or older</p>\n<p>\n 2. Employed at one of the study sites as research staff contributing to this study</p>\n
      • principal_exclusion_criteria<p>\n <strong>Trial Participants</strong></p>\n<p>\n 1. Unable to understand the study purpose and procedures</p>\n<p>\n 2. Allergy to cephalosporin (cefixime), macrolide (erythromycin or azithromycin), or tetracycline (doxycycline) class antibiotics</p>\n<p>\n 3. Recent use of prolonged antibiotics (≥14-day course in the month before enrolment) Use of medications that impact cefixime, azithromycin, or doxycycline metabolism (check versus list in screening SOP)</p>\n<p>\n <strong>Study Staff</strong></p>\n<p>\n None</p>\n
      • primary_end_points<p>\n The primary trial outcome will be the combined prevalence of NG, CT, and early syphilis ascertained by laboratory diagnosis (e.g., positive NAAT for NG or CT or new syphilis diagnosis, based on first positive rapid plasma reagin [RPR] or a fourfold increase in non-treponemal titres); the prevalence of each pathogen individually will be secondary outcomes. Outcomes will be assessed at baseline and every 3 months for 18 months. We have selected prevalence instead of incidence as our outcome of interest, because a major drawback of syndromic treatment is its failure to identify and treat asymptomatic infections that can therefore persist as a reservoir for transmission, despite spontaneous clearance of some infections. 46 To detect a 33% reduction in STI prevalence (from 16.0% to 10.8%) for each intervention compared to standard care, we will need 2,465.</p>\n
      • scope_diagnosis1
      • scope_prophylaxis1
      • scope_therapy1
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p align=\"left\" style=\"margin-left:36.0pt;\">\n <u><strong>Detailed description of the three sites is attached in each of the site specific addendum</strong></u></p>\n<p align=\"left\" style=\"margin-left:36.0pt;\">\n <strong>In Mombasa</strong>, the study team will be based at the Pwani Research Centre, located at the Ganjoni Dispensary in Mombasa County, on Mnazi Mmoja Road, opposite Mombasa Sports Club. Since 1993, this site has been affiliated with the University of Washington and the University of Nairobi.</p>\n<p align=\"left\" style=\"margin-left:36.0pt;\">\n For this study, the research team will work in close collaboration with two local community-based organisations (the HIV and AIDS People Alliance of Kenya [HAPA Kenya] and the International Centre for Reproductive Health [ICRH]) located in the Mombasa area. The study will be led by Dr Eduard Sanders</p>\n<p align=\"left\" style=\"margin-left:36.0pt;\">\n <strong>Kisumu:</strong> The study will be conducted at the Anza Mapema clinic in Kisumu, which is presently serving MSM in research or prevention and care programmes. This site will be overseen by the Nyanza Reproductive Health Society and led by Dr. Fred Otieno</p>\n<p align=\"left\" style=\"margin-left:36.0pt;\">\n <strong>Nairobi:</strong> The study will be conducted at a Sex Worker Outreach Programme clinic in Nairobi, which is presently serving MSM and male sex workers. This site will be overseen by Partners for Health & Development in Africa and led by Dr. Joshua Kimani.</p>\n<p align=\"left\" style=\"margin-left:36.0pt;\">\n  </p>\n
      • other_details_explanation<p>\n Feasible, scalable, cost-effective strategies to control bacterial STI among MSM in low-resource settings are urgently needed to reduce STI burden and decrease HIV transmission risk. STI PPT has been recommended by the WHO for MSM in settings in which NAAT are unavailable, and doxyPEP is a promising STI control strategy for MSM, yet there are no data on its health and economic impact relative to standard syndromic treatment in settings in which NAAT use is prohibitively expensive. We posit that there is equipoise to conduct a randomized trial, since while doxyPEP has demonstrated efficacy in studies of MSM in well-resourced settings in which NAAT-guided treatment are widely available, none of these studies was conducted in a resource-limited setting in which syndromic treatment is the norm. In addition, there have been no clinical trials of WHO-recommended STI PPT for MSM, which could have similar or greater efficacy, especially if doxycycline resistance in NG or poor adherence limit the efficacy of doxyPEP. Randomization in a 2:2:1 allocation with a common control arm will allow evaluation of both interventions in the same trial, and an open-label design allows for optimal evaluation of effectiveness and robust evaluation of acceptability, feasibility, and safety in practice, as well as adherence and sexual behaviour among participants who are aware of their assignment.</p>\n
      • other_details_regulatory_notapproved<p>\n NACOSTI</p>\n
      • other_details_regulatory_approved<p>\n NON-KEMRI 4962 STI Control in Kenyan MSM (Mambo Matatu) approved up to 25 Jul 25. Due for submission 24 Apr 25.</p>\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_duration5 years
      • design_controlled_randomisedYes
      • design_controlled_openYes
      • design_controlled_single_blindNo
      • design_controlled_double_blindNo
      • design_controlled_parallel_groupNo
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorAzithromycin and Cefixime
      • design_controlled_other_medicinalNo
      • design_controlled_placeboNo
      • 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_countriesNo
      • multiple_member_states
      • number_of_sites3
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_siteApproximately 966 participants in each site. Non-competitive enrolment.
      • total_participants_worldwide2900
      • population_less_than_18_yearsNo
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerNo
      • population_childrenNo
      • population_adolescentNo
      • population_above_18Yes
      • population_adultNo
      • population_elderlyNo
      • gender_female0
      • 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_nameEduard
      • investigator1_middle_nameJ
      • investigator1_family_nameSanders
      • investigator1_qualificationMD,MPH, PHD
      • investigator1_professional_addressESanders@auruminstitute.org
      • investigator1_telephone+254 723593762
      • investigator1_emailESanders@auruminstitute.org
      • organisations_transferred_No
      • number_participants2900
      • notification
      • approval_date21-01-2025
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted23-09-2024
      • is_child0
      • unsubmitted1
      • initial_date_submitted23-09-2024
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonReviewer comments have been addressed
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
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      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2025-01-21 12:20:20
      • created2024-08-21 12:37:52
      • total_sites3
      • ecitizen_invoice320213
    • InvestigatorContact(array)
      • 0(array)
        • id1139
        • application_id1460
        • given_nameSusan
        • middle_name
        • family_nameGraham
        • qualificationMD, MPH, PhD
        • professional_addressAssociate Chair, Global Health Professor, Global Health Professor, Medicine - Allergy and Infectious Dis. Adjunct Professor, Epidemiology, HMC 359909, 325 9th Avenue Seattle, WA 98104-2499
        • telephone+1 206-351-0414
        • emailgrahamsm@uw.edu
        • created2024-08-25 19:01:58
        • modified2024-11-27 16:06:13
      • 1(array)
        • id1150
        • application_id1460
        • given_nameFredrick
        • middle_name
        • family_nameOtieno
        • qualificationDCMS, MPH, PhD
        • professional_addressResearch Director Nyanza Reproductive Health Society UNIM Research and Training Centre, P. O. Box 1764 Kisumu, Kenya
        • telephone+254 572 024 065
        • emailfotieno@nrhskenya.org
        • created2024-09-04 11:46:24
        • modified2024-11-27 16:06:13
      • 2(array)
        • id1151
        • application_id1460
        • given_nameJoshua
        • middle_name
        • family_nameKimani
        • qualificationMBChB MPH
        • professional_addressClinical Research Director Partners for Health & Development in Africa 5th Ngong Ave Suites, 7th Floor Room 7-9 PO Box 3737-00506 , Nairobi Kenya
        • telephone+254 202 101 155
        • emailJkimani@phdaf.org
        • created2024-09-04 11:46:24
        • modified2024-11-27 16:06:13
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        • id1772
        • application_id1460
        • county_id1
        • site_namePwani Research Centre, in collaboration with two local community-based organisations (the HIV and AIDS People Alliance of Kenya [HAPA Kenya] and the International Centre for Reproductive Health [ICRH])
        • physical_addressGanjoni Municipal Clinic, Mombasa
        • contact_detailsP.O BOX 91276-80103, Mombasa; Tel: 0771441373
        • contact_personFatma Mwidadi
        • site_capacity(null)
        • misc(null)
        • created2024-08-25 19:01:58
        • modified2024-11-27 16:06:13
        • County(array)
          • id1
          • county_nameMombasa
          • created2012-05-31 16:15:11
          • modified2012-07-09 13:06:23
      • 1(array)
        • id1773
        • application_id1460
        • county_id42
        • site_nameAnza Mapema Clinic
        • physical_addressRailways, Kisumu
        • contact_detailsUnited Mall, P.O. Box 1764 , Kisumu; 057 202 3903
        • contact_personDr. Fred Otieno
        • site_capacity(null)
        • misc(null)
        • created2024-08-27 10:38:15
        • modified2024-11-27 16:06:13
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
      • 2(array)
        • id1774
        • application_id1460
        • county_id47
        • site_nameSex Workers Outreach Programme Clinic
        • physical_addressSWOP Kenya 2nd Avenue, Thome close, Thome Estate, Off Thika RD
        • contact_details0793298954
        • contact_personDr. Joshua Kimani
        • site_capacity(null)
        • misc(null)
        • created2024-08-27 10:38:15
        • modified2024-11-27 16:06:13
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
    • Sponsor(array)
      • 0(array)
        • id774
        • application_id1460
        • sponsorNational Institutes of Health (NIH)/ National Institute of Allergy and Infectious Diseases (NIAID)/ Division of Microbiology and Infectious Diseases (DMID)
        • sponsor_typeOthers
        • contact_personSusan M Graham
        • addressHMC 359909, 325 9th Avenue Seattle, WA 98104 United States
        • telephone_number+1 206-351-0414
        • fax_number
        • cell_number+254735451225
        • email_addressgrahamsm@uw.edu
        • created2024-08-25 19:01:58
        • modified2024-11-27 16:06:13
  • 1(array)
    • Application(array)
      • id350
      • user_id224
      • trial_status_id7
      • abstract_of_study<p>\n Acute venous thromboembolism (i.e. deep-vein thrombosis [DVT] or pulmonary<br />\n embolism [PE]) is a common disorder with an annual incidence of approximately 1<br />\n or 2 cases per 1000 persons in the general population and is the third most common<br />\n cause of vascular death after myocardial infarction and stroke. The current standard<br />\n treatment for DVT is overlapping parenteral anticoagulation (e.g. LMWH) and a<br />\n vitamin K antagonist (e.g. warfarin). Parenteral anticoagulation needs to be<br />\n continued for 5 to 7 days, at least until an INR of 2.0 has been obtained, followed by<br />\n a minimum of 3 months of treatment with the vitamin K antagonist. Treatment with<br />\n vitamin K antagonists requires frequent monitoring of the international normalized<br />\n ratio (INR), and multiple interactions of vitamin K antagonists with foods and other<br />\n drugs have been reported. The duration of treatment is determined by individual risk<br />\n factors of the patient.<br />\n Rivaroxaban is a direct factor Xa inhibitor, and has been approved first in the<br />\n prevention of venous thromboembolism after elective hip and knee replacement<br />\n surgery. It does not require routine laboratory monitoring and has no food<br />\n interactions and only a few drug interactions compared to standard of care.<br />\n As part of the development program, the EINSTEIN clinical trial program was<br />\n designed to evaluate the use of rivaroxaban for the acute treatment and secondary<br />\n prevention of DVT (EINSTEIN-DVT) and PE (EINSTEIN-PE) and in long-term<br />\n secondary prevention of recurrent DVT and PE (EINSTEIN-EXT). A unique aspect<br />\n of the EINSTEIN-DVT and PE studies is the use of rivaroxaban as a single agent<br />\n (single drug approach) in contrast to the use of intravenous anticoagulants and<br />\n VKAs.<br />\n The EINSTEIN-DVT study demonstrated that rivaroxaban is at least as effective as<br />\n the current standard therapy with similar safety, in the treatment and secondary<br />\n prevention of DVT. The EINSTEIN PE study demonstrated non-inferior efficacy of<br />\n rivaroxaban compared to standard of care with similar rates of major and clinically<br />\n relevant non-major bleeding. EINSTEIN PE further demonstrated a significant<br />\n reduction of major bleeding events in patients treated with rivaroxaban compared to<br />\n standard of care. EINSTEIN-EXT demonstrated that continued treatment with<br />\n rivaroxaban after 6 or 12 months initial treatment is superior in preventing<br />\n recurrences, as compared with placebo, and has an acceptable risk of bleeding.<br />\n At the time of writing, rivaroxaban is approved by the EMA, the FDA, Singapore,<br />\n Malaysia, Indonesia, Philippines, Taiwan, Korea and Mexico, Brazil, Argentina,<br />\n Chile, Colombia, Peru, Ecuador, Uruguay, and several other countries in Latin<br />\n America as well as in the EMEA region Saudi Arabia, Egypt, Middle Africa, UAE,<br />\n Kuwait, Qatar, Turkey, Jordan, Lebanon, Russia, Kazakhstan and Algeria for the<br />\n treatment of acute DVT, PE and recurrent VTE following DVT or PE in adults. The<br />\n approved dose is 15mg bid for the first 21 days followed by 20mg od for the<br />\n continuing treatment period. Further dosing information are listed in detail in the<br />\n Summary of Product Characteristics (SmPC). In the European Union and other<br />\n countries, rivaroxaban is the first agent that allows treatment of thrombotic events<br />\n with a single drug approach. Treatment with rivaroxaban can be already initiated at<br />\n diagnosis and does not require intravenous/subcutaneous heparin or VKA anymore.<br />\n If the decision is made to switch treatment from rivaroxaban to current standard of<br />\n care, adequate anticoagulation has to be ensured. In patients converting from rivaroxaban to VKA, VKA should be given concurrently until the INR is ≥2.0.<br />\n Patients converting from rivaroxaban to parenteral anticoagulation should receive<br />\n the parenteral anticoagulant at the time originally scheduled for the intake of<br />\n rivaroxaban.<br />\n Bayer conducts the XALIA LEA study to yield complementary post-authorization<br />\n information in rivaroxaban or standard therapy patients under real-life conditions.</p>\n
      • study_title<p>\n XALIA LEA- Xarelto® for Long-term and<br />\n Initial Anticoagulation in Venous<br />\n Thromboembolism (VTE) in Latin America,<br />\n EMEA and Asia</p>\n
      • laymans_summary(null)
      • short_titleRivaroxaban for Long-term and Initial Anticoagulation in Venous Thromboembolism (VTE)
      • protocol_noECCT/14/12/01
      • version_noXA1402 (Impact No. 17237), Protocol Version 1.0
      • date_of_protocol18-02-2014
      • study_drugBay 59-7939, Rivaroxaban, Xarelto®
      • disease_conditionTreatment of deep vein thrombosis (DVT)
      • 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_nameRivaroxaban
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressselina.musalia@bayer.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_countries1
      • applicant_addendum1
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantJohn Mwangi (john.mwangi@bayer.com)
      • declaration_date103-12-2014
      • declaration_principal_investigatorDr. Anne Njambi,Dr Allibhoy Ali, Dr Charles Kariuki,Dr Martin Wanyoike
      • declaration_date203-12-2014
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n ï‚· Female or male patients, who are at >=18 years<br />\n ï‚· Diagnosis of acute DVT and/or PE, objectively confirmed<br />\n ï‚· Indication for anticoagulation therapy for at least 12 weeks<br />\n ï‚· Willing to participate in this study and available for follow-up</p>\n
      • principal_exclusion_criteria<p>\n Exclusion criteria must be read in conjunction with the local product information.<br />\n Patients who are found to receive treatment contrary to the local product information<br />\n will not be excluded. Depending on the number of patients receiving rivaroxaban<br />\n contrary to the local product information these patients can be analyzed in a separate<br />\n analysis. Further details will be described in the SAP.<br />\n  </p>\n
      • primary_end_points<p>\n Major bleedings defined as overt bleeding associated with:<br />\n  A fall in hemoglobin of ≥2 g/dL, or<br />\n  A transfusion of ≥2 units of packed red blood cells or whole blood, or<br />\n  Occurrence at a critical site: intracranial, intra-spinal, intraocular,<br />\n pericardial, intra-articular, intra-muscular with compartment syndrome,<br />\n retroperitoneal<br />\n  Death<br />\n o Symptomatic recurrent venous thromboembolic events confirmed by objective<br />\n diagnostic tools<br />\n o All-cause mortality<br />\n  </p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • 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_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n Prime Care Heart Clinic. Number of Staff:3</p>\n<p>\n Dr Silversteins Clinic.Number of Staff: 2</p>\n<p>\n Nairobi Cardiovascular Clinic.Number of Staff: 3</p>\n<p>\n Agakhan Kisumu:Number of staff 1</p>\n<p>\n Please refer to CVs attached.</p>\n<p>\n  </p>\n
      • other_details_explanation<p>\n A similar study the Rivaroxaban Once daily oral direct Factor Xa inhibition Compared with vitamin K antagonist for the prevention of stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) study was conducted to evaluate the efficacy and safety of rivaroxaban compared to the VKA warfarin in the prevention of thromboembolic events in subjects with non-valvular AF was conducted in the host country.</p>\n<p>\n The main goal is to analyze long-term safety in the use of rivaroxaban in the treatment of acute DVT and/or PE in routine clinical practice use in Latin America, Eastern Europe, Middle East and Africa.</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_duration12 months
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states10
      • number_of_sitesMultiple
      • multi_country_listLatin America, Eastern Europe,Middle East and Asia
      • data_monitoring_committeeYes
      • total_enrolment_per_site100
      • total_participants_worldwide2500
      • 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_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_nameDavid Kuria Kamau
      • investigator1_middle_nameKuria
      • investigator1_family_nameKamau
      • investigator1_qualificationMBChB , M.Med
      • investigator1_professional_addressPrime care heart clinic ,Nairobi Hospital, Nairobi Kenya
      • investigator1_telephone+254 722 578 308
      • investigator1_emailkuriakamau@gmail.com
      • organisations_transferred_No
      • number_participants100
      • notification
      • approval_date27-01-2015
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted04-12-2014
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2017-05-05 10:34:58
      • created2014-11-06 14:24:03
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id242
        • application_id350
        • given_nameAnne Njeri Mugera
        • middle_nameNjambi
        • family_nameMugera
        • qualificationMBChB, Mmed
        • professional_addressDr. Silversteins Clinic, Nairobi Hospital ,Nairobi Kenya.
        • telephone+254 722 747 695
        • emaildrannemugeraknh@gmail.com
        • created2014-11-06 14:55:10
        • modified2014-12-04 10:39:27
      • 1(array)
        • id243
        • application_id350
        • given_nameDr. Martin N Wanyoike
        • middle_nameNjoroge
        • family_nameWanyoike
        • qualificationMBChB,M.Med ,CTM
        • professional_addressPrime Care Heart Clinic , Nairobi Hospital, Nairobi Kenya
        • telephone+254 720 921 553
        • emailprimecareheartclinic@gmail.com
        • created2014-11-06 15:07:54
        • modified2014-12-04 10:39:27
      • 2(array)
        • id244
        • application_id350
        • given_nameCharles Muthui Kariuki
        • middle_nameMuthui
        • family_nameKariuki
        • qualificationMBChB,MRCP,M.Med,FRCP
        • professional_addressNairobi Cardiovascular Clinic, NairobI Hospital ,Nairobi ,Kenya
        • telephone+254 733 370 057
        • emailckthreesk@gmail.com
        • created2014-11-06 15:13:05
        • modified2014-12-04 10:39:27
      • 3(array)
        • id245
        • application_id350
        • given_nameFEROZ ALI
        • middle_name
        • family_nameAllibhoy
        • qualificationMBBS
        • professional_addressP.O Box 530 Kisumu
        • telephone(057)2020005 / 2023300
        • emaildr.f.allibhoy@live.com
        • created2014-11-10 16:11:56
        • modified2014-12-04 10:39:27
    • SiteDetail(array)
      • 0(array)
        • id293
        • application_id350
        • county_id47
        • site_namePrimecare Heart Clinic
        • physical_addressPrime care Heart clinic Nairobi Hospital , Nairobi , Kenya
        • contact_detailsP.O.BOX 19552-00202 NAIROBI
        • contact_personDr. Martin Wanyoike
        • site_capacity(null)
        • misc(null)
        • created2014-11-06 14:55:10
        • modified2014-12-04 10:39:27
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 1(array)
        • id294
        • application_id350
        • county_id47
        • site_nameDr. Silversteins Clinic
        • physical_addressDr.Silversteins Clinic , Nairobi Hospita Nairobi Kenya.
        • contact_details+254 722 747 695
        • contact_personDr.Anne Mugera
        • site_capacity(null)
        • misc(null)
        • created2014-11-06 15:35:33
        • modified2014-12-04 10:39:27
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 2(array)
        • id295
        • application_id350
        • county_id47
        • site_nameNairobi Cardiovascular Clinic
        • physical_addressNairobi Cardiovascular Clinic,Nairobi Hospital, Nairobi Kenya
        • contact_details+254 733 370 057
        • contact_personDr.Charles Kariuki
        • site_capacity(null)
        • misc(null)
        • created2014-11-06 15:35:33
        • modified2014-12-04 10:39:27
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 3(array)
        • id296
        • application_id350
        • county_id42
        • site_nameAgah Khan Kisumu
        • physical_addressKisumu
        • contact_detailsP.O Box 530 Kisumu
        • contact_personDr Allibhoy Feroz Ali
        • site_capacity(null)
        • misc(null)
        • created2014-11-10 16:13:39
        • modified2014-12-04 10:39:28
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
    • Sponsor(array)
      • 0(array)
        • id185
        • application_id350
        • sponsorBayer HealthCare AG, Germany
        • sponsor_type(null)
        • contact_personChristopher Maina Wairegi
        • address30321-00100 Thika Road/Outering road , Ruaraka
        • telephone_number+254 20 8600000
        • fax_number+254 20 8600010
        • cell_number+254 700 390 311
        • email_addresschristopher.wairegi@bayer.com
        • created2014-11-06 14:55:10
        • modified2014-12-04 10:39:27
  • 2(array)
    • Application(array)
      • id96
      • user_id68
      • trial_status_id1
      • abstract_of_study<p>\n This international study is a prospective non-interventional observational cohort study of patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism. Patients will be followed up for 1 year or until 30 days after end of rivaroxaban therapy in case of therapy was discontinued earlier than 12 months. Serious adverse events will be followed up adequately. Laboratory values (e.g., Hb, HCT, haemoccult) should be documented for each point in time they were measured.</p>\n
      • study_title<p>\n XANTUS EMEA-LA. Xarelto® on prevention of stroke and non-central nervous system systemic embolism in patients with non-valvular atrial fibrillation in Eastern EU, Middle East, Africa (EMEA) and Latin America (LATAM): A non-interventional study</p>\n
      • laymans_summary(null)
      • short_title(null)
      • protocol_noECCT/13/04/02
      • version_noXA1206
      • date_of_protocol06-12-2012
      • study_drugRivaroxaban/ BAY 59-7939
      • disease_conditionPrevention of stroke and non-CNS systemic embolism in adult patients with non-valvular atrial fibrillation
      • 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_nameRivaroxaban
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressElizabeth.Wala@bayer.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_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDr Elizabeth Wala
      • declaration_date112-04-2013
      • declaration_principal_investigatorDr Charles Kariuki
      • declaration_date212-04-2013
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n Female and male patients ≥ 18 years of age with a diagnosis of non-valvular atrial fibrillation who start treatment with rivaroxaban to prevent stroke or non-CNS systemic embolism, and who consent to participate in the study. All contra-indications according to the local marketing authorization should be considered.</p>\n
      • principal_exclusion_criteria<p>\n <18years</p>\n<p>\n refusing consent</p>\n<p>\n not having non-valvular Atrial Fibrillation</p>\n
      • primary_end_points<table border=\"1\" cellpadding=\"0\" cellspacing=\"0\">\n <tbody>\n <tr>\n <td style=\"width:437px;height:33px;\">\n <p>\n ï‚· Major bleeding events, collected as serious or no serious adverse events and defined as overt bleeding associated with:</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:437px;height:31px;\">\n <p>\n o a fall in haemoglobin of ≥2 g/dL, or o a transfusion of ≥2 units of packed red blood cells or whole blood, or</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:437px;height:39px;\">\n <p>\n o occurrence at a critical site (intracranial, intra-spinal, intraocular, pericardial, intra articular, intra-muscular with compartment syndrome, retroperitoneal), or o death.</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:437px;height:10px;\">\n <p>\n ï‚· Adverse events and serious adverse events</p>\n </td>\n </tr>\n <tr>\n <td style=\"width:437px;height:33px;\">\n <p>\n ï‚· All-cause mortality Major bleeding events, stroke, TIA systemic embolism, myocardial infarction will be adjudicated.</p>\n </td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n Study co-ordinator: Dr Redempter Kimeu</p>\n<p>\n 5 Physician/Cardiologists</p>\n<p>\n 10 nurses</p>\n<p>\n Adequate site facility</p>\n
      • other_details_explanation<p>\n N/A</p>\n
      • other_details_regulatory_notapproved<p>\n For the following countries:</p>\n<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" width=\"96\">\n <colgroup>\n <col />\n </colgroup>\n <tbody>\n <tr height=\"21\">\n <td height=\"21\" style=\"height:21px;width:96px;\">\n Algeria</td>\n </tr>\n <tr height=\"21\">\n <td height=\"21\" style=\"height:21px;\">\n Belarus</td>\n </tr>\n <tr height=\"21\">\n <td height=\"21\" style=\"height:21px;\">\n Kenya</td>\n </tr>\n <tr height=\"21\">\n <td height=\"21\" style=\"height:21px;\">\n Egypt</td>\n </tr>\n <tr height=\"21\">\n <td height=\"21\" style=\"height:21px;\">\n Jordan</td>\n </tr>\n <tr height=\"21\">\n <td height=\"21\" style=\"height:21px;\">\n Kazakhstan</td>\n </tr>\n <tr height=\"21\">\n <td height=\"21\" style=\"height:21px;\">\n KSA</td>\n </tr>\n <tr height=\"21\">\n <td height=\"21\" style=\"height:21px;\">\n Kuwait</td>\n </tr>\n <tr height=\"21\">\n <td height=\"21\" style=\"height:21px;\">\n Lebanon</td>\n </tr>\n <tr height=\"21\">\n <td height=\"21\" style=\"height:21px;\">\n Morocco</td>\n </tr>\n <tr height=\"21\">\n <td height=\"21\" style=\"height:21px;\">\n Qatar</td>\n </tr>\n <tr height=\"21\">\n <td height=\"21\" style=\"height:21px;\">\n Russia</td>\n </tr>\n <tr height=\"21\">\n <td height=\"21\" style=\"height:21px;\">\n Tunisia</td>\n </tr>\n <tr height=\"21\">\n <td height=\"21\" style=\"height:21px;\">\n UAE</td>\n </tr>\n <tr height=\"21\">\n <td height=\"21\" style=\"height:21px;\">\n Ukraine</td>\n </tr>\n <tr height=\"40\">\n <td height=\"40\" style=\"height:40px;width:96px;\">\n  </td>\n </tr>\n <tr height=\"20\">\n <td height=\"20\" style=\"height:20px;\">\n Argentina</td>\n </tr>\n <tr height=\"19\">\n <td height=\"19\" style=\"height:19px;\">\n Chile</td>\n </tr>\n <tr height=\"21\">\n <td height=\"21\" style=\"height:21px;\">\n Colombia</td>\n </tr>\n <tr height=\"21\">\n <td height=\"21\" style=\"height:21px;\">\n Ecuador</td>\n </tr>\n <tr height=\"21\">\n <td height=\"21\" style=\"height:21px;\">\n Mexico</td>\n </tr>\n <tr height=\"21\">\n <td height=\"21\" style=\"height:21px;\">\n Peru</td>\n </tr>\n <tr height=\"21\">\n <td height=\"21\" style=\"height:21px;\">\n Venezuela</td>\n </tr>\n </tbody>\n</table>\n<p>\n  </p>\n
      • other_details_regulatory_approved<p>\n European Medicines Authority (EMA) for the whole protocol in the EU countries. 12th March 2012</p>\n
      • other_details_regulatory_rejected<p>\n N/AN</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration2 years
      • 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_areaNairobi Cardiovascular Clinic
      • single_site_physical_address(null)
      • single_site_contact_person(null)
      • single_site_telephone(null)
      • multiple_sites_member_stateNo
      • multiple_countriesYes
      • multiple_member_states22
      • number_of_sites
      • multi_country_listAlgeria\nBelarus\nKenya\nEgypt\nJordan\nKazakhstan\nKSA\nKuwait\nLebanon\nMorocco\nQatar\nRussia\nTunisia\nUAE\nUkraine\nArgentina\nChile\nColombia\nEcuador\nMexico\nPeru\nVenezuela\n
      • data_monitoring_committeeYes
      • total_enrolment_per_site100
      • total_participants_worldwide2000
      • 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_consentNo
      • subjects_specify
      • subjects_othersNo
      • subjects_others_specify
      • investigator1_given_nameDr Redempter
      • investigator1_middle_name
      • investigator1_family_nameKimeu
      • investigator1_qualificationPhysician
      • investigator1_professional_addressNairobi Cardiovascular Clinic
      • investigator1_telephone(null)
      • investigator1_email(null)
      • organisations_transferred_Yes
      • number_participants100
      • notification<p>\n This is a Phase IV study hence many things of Phase 1 to 3 clinical trials do not apply e.g. Investigational Product GMP, patient insurance etc.</p>\n
      • approval_date06-03-2013
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted12-04-2013
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2014-02-20 16:43:27
      • created2013-04-11 14:09:38
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id66
        • application_id96
        • given_nameDr Charles
        • middle_nameMuthui
        • family_nameKariuki
        • qualificationInterventional Cardiologist
        • professional_addressThe Nairobi Hospital
        • telephone(null)
        • email(null)
        • created2013-04-12 22:05:41
        • modified2013-04-12 22:49:59
    • SiteDetail(array)
      • 0(array)
        • id88
        • application_id96
        • county_id(null)
        • site_name
        • physical_address
        • contact_details
        • contact_person
        • site_capacity(null)
        • misc(null)
        • created2013-04-12 22:05:41
        • modified2013-04-12 22:49:59
        • County(empty)
    • Sponsor(array)
      • 0(array)
        • id51
        • application_id96
        • sponsorBayer HealthCare AG, Germany
        • sponsor_type(null)
        • contact_personDr Wala Elizabeth
        • addressP.O. Box 30321 - 00100 Nairobi, Kenya
        • telephone_number+254 20 8600 403
        • fax_number+254 20 8600 010
        • cell_number+254 722 775932
        • email_addressElizabeth.Wala@bayer.com
        • created2013-04-12 22:05:41
        • modified2013-04-12 22:49:59
  • 3(array)
    • Application(array)
      • id258
      • user_id126
      • trial_status_id6
      • abstract_of_study<p>\n Atrial fibrillation (AF) is the most common cardiac arrhythmia of clinical significance, and is an important independent risk factor for cardiogenic thromboembolic events. Oral anticoagulant therapy is highly effective for prevention of stroke in patients with atrial fibrillation. Vitamin K antagonists (VKA) have been the standard of care over the last decades.</p>\n<p>\n Rivaroxaban is a potent and selective direct Factor Xa (FXa) inhibitor and, in contrast to VKAs, can be given as fixed oral dosing without need for routine coagulation monitoring.</p>\n<p>\n This non-interventional study is a prospective observational cohort study of patients with non-valvular atrial fibrillation who are prescribed Rivaroxaban, 15 mg and 20 mg tablets under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism.</p>\n<p>\n  Inclusion criteria is Female and Male patients, who are at least 18 years of age with a diagnosis of non valvular atrial fibrillation, who consent  to participate in the study will be enrolled after the decision for a pharmacologic prophylaxis with Rivaroxaban within approved indication per country to prevent stroke or non-CNS systemic embolism has been made.</p>\n<p>\n  Patients will be followed up for 1 year or until 30 days after end of Rivaroxaban therapy in case therapy was discontinued earlier than 12 months.</p>\n<p>\n Each patient per site, treated to prevent stroke or non-CNS systemic embolism, must be consecutively screened and documented in a patient log file. No patient specific data will be documented in the patient log file.</p>\n<p>\n Female and male patients ≥ 18 years of age with a diagnosis of non-valvular atrial fibrillation who start treatment with Rivaroxaban to prevent stroke or non-CNS systemic embolism, and who consent to participate in the study. Prior anticoagulation therapy will be recorded in the CRF. All contra-indications according to the local marketing authorization should be considered. The main goal of this non-interventional study is to confirm the known safety profile of Rivaroxaban in clinical practice use.</p>\n<p>\n The end of the study will be reached 12 months after enrolment has ended.</p>\n
      • study_title<p>\n XANTUS-EL, Xarelto on prevention of stroke and non-central nervous system systemic embolism in patients with non valvular atrial fibrillation - a non interventional study, XA 1206 (IMPACT No. 16691)</p>\n<p>\n  </p>\n
      • laymans_summary(null)
      • short_titleRivaroxaban on prevention of stroke and non-central nervous system systemic embolism in patients with non valvular atrial fibrillation
      • protocol_noECCT/14/03/02
      • version_no1.2
      • date_of_protocol16-11-2012
      • study_drugXarelto
      • disease_conditionPrevention of stroke and non-CNS systemic embolism in non-valvular atrial fibrillation
      • 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_nameRivaroxaban
      • product_type_medical_device_name
      • comparator(null)
      • comparator_name(null)
      • comparator_registered(null)
      • comparator_countries(null)
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressjohn.mwangi@bayer.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_countries0
      • applicant_addendum0
      • applicant_fees1
      • applicant_complete_form(null)
      • applicant_impd(null)
      • applicant_prev_data(null)
      • applicant_stability_data(null)
      • applicant_analysis_cert(null)
      • applicant_pictorial_sample(null)
      • applicant_gcp_training(null)
      • applicant_dsmb_charter(null)
      • applicant_detailed_budget(null)
      • applicant_indemnity_pi(null)
      • applicant_practice_license(null)
      • applicant_registration_ctr(null)
      • applicant_pan_african(null)
      • applicant_hard_copies(null)
      • applicant_signed_checklist(null)
      • statistical_analysis_plan(null)
      • applicant_contractual_agreement(null)
      • declaration_applicantDr John Mwangi
      • declaration_date104-03-2014
      • declaration_principal_investigatorDr Eva Wainaina
      • declaration_date204-03-2014
      • placebo_presentNo
      • study_objectives(null)
      • principal_inclusion_criteria<p>\n Female and male patients at least 18 years of age witha a diagnosis of non-vulvular atrial fibrillation who consent.</p>\n
      • principal_exclusion_criteria<p>\n Age below 18 years; anyone who does not meet inclusion criteria</p>\n
      • primary_end_points<p>\n - Major bleeding events as defined in the protocol</p>\n<p>\n - Adverse events and serious adverse events</p>\n<p>\n - All cause mortality</p>\n
      • scope_diagnosis0
      • scope_prophylaxis1
      • scope_therapy1
      • scope_safety1
      • scope_efficacy0
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others0
      • scope_others_specify
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory0
      • trial_therapeutic_use1
      • design_controlledNo
      • site_capacity(null)
      • staff_numbers<p>\n Number of staff: 6</p>\n<p>\n - 4 MBChB, MMed, Cardiology; - 2 MBChB: Dr. Hussein Gin, Dr. M. Noorani, Dr. M Warshow, Dr. N. Sheikh, Dr. P. Omondi, Dr. Rajiv Patel</p>\n<p>\n 6 nurses, 3 cardiac technicians</p>\n<p>\n Cardiac Laboratory</p>\n<p>\n Hospital Lab/ facilities</p>\n
      • other_details_explanation<p>\n A similar study the Rivaroxaban Once daily oral direct Factor Xa inhibition Compared with vitamin K antagonist for the prevention of stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) study was conducted to evaluate the efficacy and safety of rivaroxaban compared to the VKA warfarin in the prevention of thromboembolic events in subjects with non-valvular AF was conducted in the host country.</p>\n<p>\n The main goal of this non-interventional study (NIS) is to confirm the known safety profile of rivaroxaban in clinical practice use in Latin America, Eastern Europe, Middle East and Africa.</p>\n
      • other_details_regulatory_notapproved<p>\n n/a</p>\n
      • other_details_regulatory_approved<p>\n EMA, Russia</p>\n
      • other_details_regulatory_rejected<p>\n None</p>\n
      • other_details_regulatory_halted<p>\n N/A</p>\n
      • estimated_duration12 months
      • design_controlled_randomised
      • design_controlled_open
      • design_controlled_single_blind
      • design_controlled_double_blind
      • design_controlled_parallel_group
      • design_controlled_cross_over
      • design_controlled_other
      • design_controlled_specify
      • design_controlled_comparator
      • design_controlled_other_medicinal
      • design_controlled_placebo
      • design_controlled_medicinal_other
      • design_controlled_medicinal_specify
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesYes
      • multiple_member_states10
      • number_of_sites3
      • multi_country_listEastern Europe, Middle East, Africa and Latin America
      • data_monitoring_committeeYes
      • total_enrolment_per_site100
      • total_participants_worldwide6500
      • 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_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_nameWarshow
      • investigator1_middle_nameMajid
      • investigator1_family_nameMbarak
      • investigator1_qualificationM.Med
      • investigator1_professional_address20708-00200 Nairobi
      • investigator1_telephone+254722412201
      • investigator1_emailchubaone@gmail.com
      • organisations_transferred_No
      • number_participants100
      • notification
      • approval_date16-11-2012
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted11-03-2014
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reason
      • final_report(null)
      • implication_results(null)
      • quantity_imported(null)
      • quantity_dispensed(null)
      • quantity_destroyed(null)
      • quantity_exported(null)
      • balance_site(null)
      • final_date(null)
      • modified2016-01-07 01:23:48
      • created2014-01-21 12:30:37
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
      • 0(array)
        • id190
        • application_id258
        • given_nameWarshow
        • middle_nameMajid
        • family_nameMbarak
        • qualificationM.Med
        • professional_address20708-00200 Nairobi
        • telephone+254722412201
        • emailchubaone@gmail.com
        • created2014-01-21 12:35:01
        • modified2014-03-11 17:10:09
    • SiteDetail(array)
      • 0(array)
        • id237
        • application_id258
        • county_id47
        • site_nameMP Shah Hospital
        • physical_addressParklands
        • contact_details20708-00200, Nairobi
        • contact_personDr Majid M. Warshow
        • site_capacity(null)
        • misc(null)
        • created2014-01-21 12:35:01
        • modified2014-03-11 17:10:09
        • County(array)
          • id47
          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
    • Sponsor(array)
      • 0(array)
        • id149
        • application_id258
        • sponsorBayer Healthcare AG Berlin
        • sponsor_type(null)
        • contact_personEva Wainaina
        • address30321-00100 Nairobi
        • telephone_number+254 208600406
        • fax_number+254208600010
        • cell_number+254705840706
        • email_addresseva.wainaina@bayer.com
        • created2014-01-21 12:35:01
        • modified2014-03-11 17:10:09
  • 4(array)
    • Application(array)
      • id1189
      • user_id60
      • trial_status_id7
      • abstract_of_study<p>\n <strong>Background:</strong> Yellow fever (YF) is a viral disease transmitted by a mosquito; the Aedes aegypti and Haemagogous species mosquitoes, during the rainy season. This disease is endemic in the tropical and subtropical areas in South America and Africa.  Vaccination is the most important means of preventing the infection. There are other approved vaccines for YF but the uptake has not been adequate due to vaccine shortage as a result of available vaccine stock being diverted to preventive campaigns; this has significantly affected the supply to immunization programs and the global supply for travelers too. WHO reports a total of 47 countries, including 34 from Africa and 13 from Central and South America, endemic for YF. As per WHO, the estimated number of severe cases in both continents is 84,000-170,000, with approximately 29,000-60,000 deaths annually. The outbreaks are necessitating an urgent response. In such an event, a global shortage of YF vaccine is not uncommon. This has given rise to evaluation of measures to counter this shortage such as fractional dosing of YF vaccines.</p>\n<p style=\"margin-left:-.25pt;\">\n <strong>Purpose and rationale:</strong> The vaccine supply is still a major obstruction These low YF vaccination coverages indicate the presence of an underlying susceptible population at risk of YF and a risk of continued transmission. Hence, SIIPL has developed this Yellow Fever Vaccine to address this issue of yellow fever vaccine shortage. SIIPL has developed a Yellow Fever vaccine which contains the same 17D-213 vaccine strain used in already licensed and WHO prequalified vaccines.  </p>\n<p style=\"margin-left:-.25pt;\">\n <strong>Objective:</strong> To demonstrate the non-inferiority of the immune responses generated by SII-YFV compared to STAMARIL^® in terms of YF neutralizing antibody (NAb) seroconversion rates as determined by plaque reduction neutralization test (PRNT₅₀).</p>\n<p>\n <strong>Methodology:</strong> The study will be conducted in Kenya at the KEMRI CRDR Clinical Research Annex- Nairobi. The expected study duration is approximately 24months, individual participation will be approximately 7months. Healthy male or female volunteers aged ≥ 1 to < 60 years will be divided into three age groups of ≥ 1 to < 10 years, ≥ 10 to < 18 years and ≥ 18 to < 60 years and into the immunogenicity and reactogenicity cohort for the three age groups. They will be randomized in the ratio of 3:2 to receive the allocated IP. A total of 2280 participants will be enrolled; Nairobi site will recruit at least 1140 participants. A single dose of either SII-YFV or STAMARIL^® will be administered subcutaneously to the study participants. There will be three scheduled visits during the study.  A screening and vaccination visit (Day 0) followed by additional study visits on Day 28 and on Day 180 post-vaccination. Prior to enrolment participants will be taken through consenting and will sign assent/consent; only eligible participants will be enrolled into the study.</p>\n<p style=\"margin-left:-.25pt;\">\n <strong>Expectation: </strong>The current Phase III study is designed to demonstrate the non-inferiority in terms of the seroconversion rates achieved with SII YF vaccine versus STAMARIL. This study will support prequalification by the WHO for global application. This will improve YF vaccination coverages and reduce susceptibility of populations at risk of YF and a risk of continued transmission.</p>\n
      • study_title<p>\n YWF:03: A PHASE III, MULTICENTER, DOUBLE BLIND, RANDOMIZED STUDY OF SII YELLOW FEVER VACCINE TO COMPARE SAFETY AND IMMUNOGENICITY WITH STAMARIL^®</p>\n<p>\n  </p>\n
      • laymans_summary<p>\n Yellow fever is a viral disease spread by a mosquito during the rainy season. This disease is widespread in the tropical and subtropical areas in South America and Africa. The important prevention measure is vaccination. There are other approved vaccination for YF but the uptake is not satisfactory as a result of vaccine shortage, this is because the available vaccines stocks are sidetracked to preventive campaigns which has affected the supply of this vaccine to the immunization program and the global supply for travelers too. WHO reports a total of 47 countries, including 34 from Africa and 13 from Central and South America; YF is widespread in these regions.. As per WHO, the estimated number of serious cases in both continents is 84,000-170,000, with approximately 29,000-60,000 deaths annually. The outbreaks are necessitating an urgent response. There are a limited number of manufacturers of YF vaccine. In such an event, a global shortage of YF vaccine is not uncommon. This has given rise to evaluation of measures to counter this shortage such as fractional dosing of YF vaccines. The vaccine supply is still a major obstruction; these low YF vaccination coverages indicate the presence of populations facing the danger of YF and a danger of continued transmission. Hence, SIIPL has developed this Yellow Fever Vaccine to address this issue of   YF vaccine shortage. SIIPL has developed a YF vaccine which contains the same 17D-213 vaccine strain used in already licensed and WHO prequalified vaccines. The objective of this study is to demonstrate that the immune responses generated by SII-YFV are equal or more effective as compared to STAMARIL^® .The study will be conducted in Kenya at the KEMRI CRDR Clinical Research Annex- Nairobi. The expected study duration is approximately 24months, individual participation will be approximately 7months. Healthy male or female volunteers aged ≥ 1 to < 60 years will be divided into three age groups of ≥ 1 to < 10 years, ≥ 10 to < 18 years and ≥ 18 to < 60 years and into the immunogenicity and reactogenicity cohort for the three age groups. They will be randomized in the ratio of 3:2 to receive the allocated either SII-YFV or STAMARIL. A total of 2280 participants will be enrolled in to the study in Kenya; Nairobi site will recruit at least 1140 participants. A single dose of either SII-YFV or STAMARIL^® will be administered subcutaneously to the study participants. There will be three scheduled visits during the study.  A screening and vaccination visit (Day 0) followed by additional study visits on Day 28 and on Day 180 post-vaccination. Prior to enrolment participants will be taken through consenting and will sign assent/consent as applicable; only eligible participants will be enrolled into the study. The results of this study will support prequalification by the WHO for global application. This will improve YF vaccination coverages and reduce contact of populations at danger of YF and a risk of continued transmission.</p>\n
      • short_titleYWF:03
      • protocol_noECCT/22/11/04
      • version_no3.1
      • date_of_protocol07-10-2022
      • study_drugSII Yellow Fever Vaccine
      • disease_conditionYellow Fever
      • 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_nameN/A
      • product_type_medical_device_nameN/A
      • comparatorYes
      • comparator_nameStamaril
      • comparator_registeredYes
      • comparator_countriesMost countries globally; WHO prequalified
      • ecct_not_applicable0
      • ecct_ref_number
      • email_addressvnduba@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
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      • declaration_applicantDr. Julius Kiuri
      • declaration_date130-11-2022
      • declaration_principal_investigatorDr. Videlis Nduba
      • declaration_date230-11-2022
      • placebo_presentNo
      • study_objectives<div>\n <strong>Primary Objective</strong></div>\n<div>\n To demonstrate the non-inferiority of the immune responses generated by SII-YFV compared to STAMARIL® in terms of YF neutralizing antibody (NAb) seroconversion rates as determined by plaque reduction neutralization test (PRNT50).</div>\n<div>\n  </div>\n<div>\n <strong>Secondary Objectives </strong></div>\n<div>\n •<span style=\"white-space:pre\"> </span>To compare the YF NAb geometric mean titres (GMTs) generated following SII-YFV to those generated following STAMARIL®. </div>\n<div>\n •<span style=\"white-space:pre\"> </span>To determine the impact of pre-existing flavivirus antibodies on YFV immunogenicity. </div>\n<div>\n •<span style=\"white-space:pre\"> </span>To compare the safety and tolerability of SII-YFV to STAMARIL®.  </div>\n<div>\n  </div>\n
      • principal_inclusion_criteria<ol>\n <li>\n Male or female volunteers aged ≥ 1 to < 60 years </li>\n <li>\n Healthy volunteers as determined by medical history and clinical examination </li>\n <li>\n Participants willing to adhere to the protocol requirements and to provide informed consent for participants ≥ 18 years of age. For participants < 18 years of age, parental/guardian ability and willingness to provide informed consent (as per local requirements/procedures) and additional informed assent from participants, as appropriate for participating community (i.e. participants at least 7 years of age in Kenya)</li>\n <li>\n Intend to remain residing in study area throughout the study participation</li>\n <li>\n Female participants of childbearing potential* must have practiced adequate contraception** and agree to continue adequate contraception till Day 28 post-vaccination. </li>\n</ol>\n<p style=\"margin-left:27.5pt;\">\n *Females can be considered not of childbearing potential only if they are pre-menarche and less than 12 years of age, or with current bilateral tubal ligation or occlusion, or posthysterectomy, or post-bilateral ovariectomy, or post-menopause.</p>\n<p style=\"margin-left:27.5pt;\">\n **Adequate contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly and when applicable, in accordance with the product label as follows:</p>\n<ul>\n <li>\n Abstinence from penile-vaginal intercourse, when this is the preferred and usual lifestyle</li>\n <li>\n Combined estrogen and progesterone oral contraceptives</li>\n <li>\n Injectable progestogen</li>\n <li>\n Implants of etonogestrel or levonorgestrel</li>\n <li>\n Contraceptive vaginal ring</li>\n <li>\n Percutaneous contraceptive patches</li>\n <li>\n Intrauterine device or intrauterine system</li>\n <li>\n Male partner (sole partner for participant) sterilized</li>\n <li>\n Male condom combined with a vaginal spermicide (foam, gel, film, cream or suppository), and/or progesterone alone oral contraceptive</li>\n</ul>\n<ol>\n <li value=\"6\">\n Female participants of childbearing potential must have a negative pregnancy test within 24 hours prior to IP administration.</li>\n <li value=\"7\">\n Be willing to avoid the use of traditional/herbal local medications and treatments for the duration of the study  </li>\n</ol>\n
      • principal_exclusion_criteria<ol>\n <li>\n Fever (<u>></u> 37.5°C) or any clinically significant acute infection at time of vaccination [Temporary exclusion criteria – participants may be re-screened at least 48 hours after the last recorded fever]</li>\n <li>\n Use of systemic (oral or parenteral) antibiotics or antiviral agents within the past 7 days. [Temporary exclusion criteria – participants may be re-screened at least 7 days after last dose of antibiotics or antiviral agents]</li>\n <li>\n Use of traditional/herbal local medications and treatments in the past 7 days [Temporary exclusion criteria – participants may be re-screened at least 7 days after last consumption of traditional/herbal local medications and treatment]</li>\n <li>\n Previous history of laboratory confirmed infection with yellow fever and other flaviviruses e.g., dengue fever, tick-borne-encephalitis (TBE), Japanese encephalitis (JE), West Nile virus (WNV), zika virus, etc.</li>\n <li>\n Previous vaccination against yellow fever, TBE, JE, or dengue fever.</li>\n <li>\n Receipt of any vaccine within past 28 days or planned vaccination until completion of Day 28 visit</li>\n <li>\n Known or suspected impairment of immunological function based on medical history and physical examination.</li>\n <li>\n Presence of any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, immunological, dermatological, neurological, cancer, or autoimmune disease) as determined by medical history and / or physical examination which would compromise the participant’s health or is likely to result in nonconformance to the protocol</li>\n <li>\n History of chronic administration (defined as more than 14 consecutive days) of immunosuppressant (> 0.5 mg/kg/day of prednisolone or equivalent) or other immune modifying drugs including the use of glucocorticoids. The use of topical/inhaled/per nasal glucocorticoids will be permitted.</li>\n <li>\n A known hypersensitivity to any of the vaccine components (including gelatin, eggs, egg products, or chicken protein) or history of a life-threatening reaction to any past vaccine.</li>\n <li>\n Receipt of any immunoglobulin therapy and / or blood products in the past 60 days or planned administration until completion of Day 28 visit.</li>\n <li>\n Participation in a drug research study, involving investigational products, within past 3 months or planned participation during the entire study period</li>\n <li>\n Receipt of any investigational or unlicensed medication (drug or vaccine) in the preceding 28 days, or planned use until completion of Day 28 visit</li>\n <li>\n Uncontrolled coagulopathy or blood disorder contraindicating subcutaneous injections or blood sampling</li>\n <li>\n Be an employee of, or direct descendant (child or grandchild) of any person employed by the investigator or sponsor.</li>\n <li>\n Pregnant or lactating women</li>\n <li>\n Requirement of Yellow Fever vaccination certificate for travelling purpose</li>\n <li>\n History of thymus dysfunction including myasthenia gravis, thymoma, thymectomy</li>\n <li>\n History or presence of significant alcoholism or drug abuse in the past one year</li>\n <li>\n Major congenital or genetic defect</li>\n <li>\n Any other condition which in the opinion of the investigator will jeopardize the safety of the participant or compromise the assessment of the study objectives</li>\n</ol>\n
      • primary_end_points<div>\n Percentage seroconversion* on Day 28 post-vaccination</div>\n<div>\n  </div>\n<div>\n *Seroconversion is defined as a four-fold rise in YF NAb (PRNT₅₀) titres from baseline</div>\n
      • scope_diagnosis0
      • scope_prophylaxis0
      • scope_therapy0
      • scope_safety1
      • scope_efficacy1
      • scope_pharmacokinetic0
      • scope_pharmacodynamic0
      • scope_bioequivalence0
      • scope_dose_response0
      • scope_pharmacogenetic0
      • scope_pharmacogenomic0
      • scope_pharmacoecomomic0
      • scope_others1
      • scope_others_specifyImmunogenicity
      • trial_human_pharmacology0
      • trial_administration_humans0
      • trial_bioequivalence_study0
      • trial_other0
      • trial_other_specify
      • trial_therapeutic_exploratory0
      • trial_therapeutic_confirmatory1
      • trial_therapeutic_use0
      • design_controlledYes
      • site_capacity(null)
      • staff_numbers<p>\n KEMRI-CRDR</p>\n<p>\n Site staff include the principal investigator, 3 medical officers, 3 pharmacists, 1 pharm tech, 5 nurses, 9 lab personnel, 5 quality assurance officers, 4 clinical officers, 3 administrators and 12 community health workers.</p>\n<p>\n This facility has several clinical rooms available for consenting, nursing procedures, clinical exams and dosing. There are also additional facilities that include 3 bed male and female inpatient ward for admission when required, staff work areas, a monitoring space, a pharmacy, a conference board room, a laboratory and kitchen for preparing participant meals.</p>\n<p>\n VIBRI</p>\n<div>\n The trial site and its satellites have the capacity to conduct this trial to the highest international standards in accordance with Good Clinical Practice (GCP) and Human Subjects Protection requirements. The trial site has the human resources, pharmacy and laboratory infrastructure, clinical examination rooms, data entry rooms with good internet services, monitoring space and office space for work and meetings.</div>\n
      • other_details_explanation<ul>\n <li>\n N/A</li>\n <li>\n Study is conducted in Kenya. Due to the lower Yellow Fever incidence in India, it is not feasible for sample size reasons to conduct a Phase III Trial in this nation.</li>\n <li>\n Consequently the study will be conducted in a high incidence African nation.</li>\n</ul>\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 N/A</p>\n
      • estimated_duration24 Months
      • design_controlled_randomisedYes
      • design_controlled_openNo
      • design_controlled_single_blindNo
      • design_controlled_double_blindYes
      • design_controlled_parallel_groupYes
      • design_controlled_cross_overNo
      • design_controlled_otherNo
      • design_controlled_specify
      • design_controlled_comparatorStamaril
      • design_controlled_other_medicinalYes
      • design_controlled_placeboNo
      • design_controlled_medicinal_otherYes
      • design_controlled_medicinal_specifyActive Comparator
      • single_site_member_stateNo
      • location_of_area
      • single_site_physical_address
      • single_site_contact_person
      • single_site_telephone
      • multiple_sites_member_stateYes
      • multiple_countriesNo
      • multiple_member_states
      • number_of_sites2
      • multi_country_list
      • data_monitoring_committeeYes
      • total_enrolment_per_siteAt least 912 in each site
      • total_participants_worldwide1824
      • population_less_than_18_yearsYes
      • population_uteroNo
      • population_preterm_newbornNo
      • population_newbornNo
      • population_infant_and_toddlerYes
      • population_childrenYes
      • population_adolescentYes
      • population_above_18Yes
      • population_adultYes
      • population_elderlyYes
      • 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_othersYes
      • subjects_others_specifyFor children (≥1 year to < 18 years of age), consent to participate in the study will be requested from parents or guardians.
      • investigator1_given_nameVidelis
      • investigator1_middle_name
      • investigator1_family_nameNduba
      • investigator1_qualificationMBChB, MPH, PhD
      • investigator1_professional_addressP.O. Box 47855-00100, Nairobi KEMRI-CRDR KNH Complex, Off Hospital Road
      • investigator1_telephone+254724522474
      • investigator1_emailvnduba@gmail.com
      • organisations_transferred_Yes
      • number_participants1824
      • notification
      • approval_date26-02-2023
      • submitted1
      • deleted0
      • deleted_date(null)
      • deactivated0
      • date_submitted30-11-2022
      • is_child0
      • unsubmitted0
      • initial_date_submitted(null)
      • admin_stopped0
      • admin_stopped_reason(null)
      • approved2
      • approved_reasonThe reviewer comments have been responded to.
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      • quantity_imported(null)
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      • quantity_destroyed(null)
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      • balance_site(null)
      • final_date(null)
      • modified2025-03-12 07:21:43
      • created2022-11-19 12:53:18
      • total_sites(null)
      • ecitizen_invoice(null)
    • InvestigatorContact(array)
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        • application_id1189
        • given_nameVidelis
        • middle_name
        • family_nameNduba
        • qualificationMBChB, MPH, PhD
        • professional_addressP.O. Box 47855-00100, Nairobi KEMRI-CRDR KNH Complex, Off Hospital Road
        • telephone+254724522474
        • emailvnduba@gmail.com
        • created2022-11-19 13:09:22
        • modified2022-11-30 19:14:48
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        • application_id1189
        • given_nameOtieno
        • middle_name
        • family_nameWalter
        • qualificationMBChB, MMed(Paed), PhD
        • professional_addressP.O. Box 47855-00100, Nairobi KEMRI-CRDR, KNH Complex, Off Hospital Road
        • telephone+254724522474
        • emailvnduba@gmail.com
        • created2022-11-24 14:19:12
        • modified2022-11-30 19:14:48
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        • site_nameKEMRI-CRDR
        • physical_addressKEMRI/CRDR Clinical Research Annex - KENYATTA NATIONAL HOSPITAL OFF HOSPITAL ROAD P.O BOX 47855-00100 NAIROBI-KENYA
        • contact_detailsP.O. Box 47855, NAIROBI 00100, Kenya, Tel: (020) 2724262/4/5
        • contact_personDr Videlis Nduba
        • site_capacity(null)
        • misc(null)
        • created2022-11-19 13:09:22
        • modified2022-11-30 19:14:48
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          • county_nameNairobi City
          • created2012-06-15 10:27:40
          • modified2012-06-15 10:27:40
      • 1(array)
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        • application_id1189
        • county_id42
        • site_nameVictoria Biomedical Research Institute (VIBRI)
        • physical_addressKisumu County Referral Hospital Off Ang’awa Road
        • contact_detailsP.O Box 7180-40100 Kisumu, Kenya Email: info@vibriafrica.org Tel: +254 (0) 720 597 654
        • contact_personDr. Lucas Otieno Tina
        • site_capacity(null)
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        • created2022-11-30 18:45:48
        • modified2022-11-30 19:14:48
        • County(array)
          • id42
          • county_nameKisumu
          • created2012-06-15 10:27:02
          • modified2012-06-15 10:27:02
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        • id615
        • application_id1189
        • sponsorSerum Institute of India Pvt Ltd
        • sponsor_typeIndustry
        • contact_personDr Sajjad Desai
        • address212/2, Soli Poonawalla Road, Hadapsar. Pune. 411028, India
        • telephone_number +91-20-26993900
        • fax_number+ 91-20-26993945
        • cell_number +91-20-26993900
        • email_addresssajjad.desai@seruminstitute.com
        • created2022-11-19 13:09:22
        • modified2022-11-30 19:14:48
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