Clinical Trial Applications - Approved: Filter, Search, and view applications
| # | Protocol No | Study Title | Investigator(s) & Site(s) | Date Approved | |
|---|---|---|---|---|---|
201. |
ECCT/23/04/05 | BiMVaC01 A randomised, controlled clinical trial to assess and compare the immunogenicity, safety and reactogenicity of the bivalent Omicron BA.4/BA.5 adapted, and the original Wuhan-Hu-1-strain, BNT162b2 COVID-19 vaccine formulations in healthy unvaccinated East African adults. |
Principal Investigator(s) 1. NDUNGU FRANCIS 2. Said Jongo Site(s) in Kenya KEMRI-CGMRC Kilifi |
06-07-2023 |
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202. |
ECCT/23/02/06 | BOHEMIA Safety and Efficacy A Phase III cluster-randomized, open-label, clinical trial to study the safety and efficacy of ivermectin mass drug administration to reduce malaria transmission in Kwale, Kenya. |
Principal Investigator(s) 1. Marta Ferreira Maia 2. Joseph Mwangangi Site(s) in Kenya Kwale county, subcounties Lungalunga and Msambweni |
25-06-2023 |
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203. |
ECCT/23/01/03 | PRAISE An Adaptive, Randomized, Placebo-controlled, Double-blind, Multi-center Study of Oral FT-4202, a Pyruvate Kinase Activator in Patients with Sickle Cell Disease (PRAISE) |
Principal Investigator(s) 1. Githanga Githanga Nyokabi Site(s) in Kenya 1. Gertrude\'s Children Hospital (Nairobi City county) 2. Kondele Children\'s Hospital Center for Clinical Research (CCR), (Kisumu county) 3. KEMRI/CRDR Kemri Clinical Research Annex Siaya County Referral Hospital Grounds (Siaya county) 4. Kombewa CRC (Kisumu county) |
19-06-2023 |
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204. |
ECCT/23/02/01 | Hibiscus Kid\'s Study A Single Arm, Open Label, Phase 1/2 Study to Evaluate the Pharmacokinetics and Safety of Etavopivat in Pediatric Patients with Sickle Cell Disease |
Principal Investigator(s) 1. Videlis Nduba 2. Walter Otieno 3. Isaac Tsikhutsu Site(s) in Kenya 1. AHERO CLINICAL TRIALS UNIT (Kisumu county) 2. KEMRI-Walter Reed-Kericho (Kericho county) 3. KEMRI: Siaya Clinical Research Annexe (Kisumu county) 4. Kombewa Clinical Research Centre (Kisumu county) |
14-06-2023 |
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205. |
ECCT/23/04/03 | ACTIV-2d/A5407 A Phase 3, multicenter, randomized, double-blind, 24-week study of the clinical and antiviral effect of S-217622 compared with placebo in non-hospitalized participants with COVID-19 |
Principal Investigator(s) 1. Prof Abraham Mosigisi Siika Site(s) in Kenya 1. MOI UNIVERSITY CLINICAL RESEARCH CENTRE (Uasin Gishu county) 2. Victoria Biomedical Research Institute, (Kisumu county) 3. Kenyatta National Hospital (Nairobi City county) 4. KEMRI CCR – BUTERE SITE (Kakamega county) 5. Kenya Medical Research Institute/Walter Reed Project (Kericho county) 6. KEMRI – AHERO Clinical Trials Units (Kisumu county) |
14-06-2023 |
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206. |
ECCT/23/01/06 | FENHANCE A PHASE III MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FENEBRUTINIB COMPARED WITH TERIFLUNOMIDE IN ADULT PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS CSF BIOMARKER SUBSTUDY ASSOCIATED WITH A PHASE III MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL-GROUP STUDY (GN41851) TO EVALUATE THE EFFICACY AND SAFETY OF FENEBRUTINIB COMPARED WITH TERIFLUNOMIDE IN ADULT PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS |
Principal Investigator(s) 1. Mansoor Saleh Site(s) in Kenya Aga Khan University, Nairobi |
13-06-2023 |
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207. |
ECCT/23/02/05 | Pharmacy PrEP cRCT Pharmacy delivery to expand the reach of PrEP in Kenya: cluster-randomized control trial |
Principal Investigator(s) 1. Elizabeth Anne Bukusi 2. Kenneth Ngure Site(s) in Kenya 1. Kenya Medical Research Institute, Center for Microbiology Research, Research Care and Training Programme (KEMRI-CMR-RCTP) research center (Kisumu county) 2. Kenya Medical Research Institute, Center for Clinical Research, Partners in Health and Research Development (KEMRI-CCR-PHRD) research center (Kiambu county) |
07-06-2023 |
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208. |
ECCT/23/01/04 | ACTIV-2d/A5407 A Phase 3, multicenter, randomized, double-blind, 24-week study of the clinical and antiviral effect of S-217622 compared with placebo in non-hospitalized participants with COVID-19 |
Principal Investigator(s) 1. Lucas Tina Otieno Site(s) in Kenya 1. MOI UNIVERSITY CLINICAL RESEARCH CENTRE (Uasin Gishu county) 2. Victoria Biomedical Research Institute, (Kisumu county) 3. Kenya Medical Research Institute/Walter Reed Project (Kericho county) 4. Kenyatta National Hospital (Nairobi City county) 5. Ahero Clinical Trials Unit, (Kisumu county) 6. KEMRI CCR – BUTERE SITE (Kakamega county) |
01-06-2023 |
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209. |
ECCT/23/02/02 | KARISMA An adaptive, randomized, active-controlled, open-label, sequential cohort, multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of intravenous cipargamin (KAE609) in adult and pediatric participants with severe Plasmodium falciparum malaria(KARISMA – KAE609’s Role in Severe Malaria) |
Principal Investigator(s) 1. Simon Kariuki Site(s) in Kenya KEMRI-CGHR, |
01-06-2023 |
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210. |
ECCT/23/01/08 | SKY-06 A PHASE II/III, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF TIRAGOLUMAB IN COMBINATION WITH ATEZOLIZUMAB PLUS PEMETREXED AND CARBOPLATIN/CISPLATIN VERSUS PEMBROLIZUMAB PLUS PEMETREXED AND CARBOPLATIN/CISPLATIN IN PATIENTS WITH PREVIOUSLY UNTREATED ADVANCED NON-SQUAMOUS NON-SMALL-CELL LUNG CANCER |
Principal Investigator(s) 1. Fredrick Chite Asirwa Site(s) in Kenya International Cancer Institute |
28-05-2023 |
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