Clinical Trial Applications - Approved: Filter, Search, and view applications
| # | Protocol No | Study Title | Investigator(s) & Site(s) | Date Approved | |
|---|---|---|---|---|---|
101. |
ECCT/23/03/04 | CONSTELLATION A Phase 3, randomized, double-blind, placebo-controlled study to evaluate the effect of Bi-26 (strain of Bifidobacterium longum, B. infantis) supplementation versus placebo on weight gain in underweight infants |
Principal Investigator(s) 1. Dr Lucas Otieno Tina Site(s) in Kenya 1. Victoria Biomedical Research Institute (Kisumu county) |
31-07-2023 |
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102. |
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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103. |
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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104. |
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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105. |
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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106. |
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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107. |
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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108. |
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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109. |
ECCT/23/01/02 | 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. Ogutu Bernhards Ragama Site(s) in Kenya 1. Kondele Children\'s Hospital Center for Clinical Research (CCR), (Kisumu county) 2. Gertrude\'s Children Hospital (Nairobi City county) 3. KEMRI/CRDR Kemri Clinical Research Annex Siaya County Referral Hospital Grounds, (Siaya county) 4. Kombewa CRC (Kisumu county) |
24-05-2023 |
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110. |
ECCT/23/01/01 | PROHER A PHASE IIIB, MULTINATIONAL, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY TO EVALUATE PATIENT PREFERENCE FOR HOME ADMINISTRATION OF FIXED-DOSE COMBINATION OF PERTUZUMAB AND TRASTUZUMAB FOR SUBCUTANEOUS ADMINISTRATION IN PARTICIPANTS WITH EARLY OR LOCALLY ADVANCED/ INFLAMMATORY HER2-POSITIVE BREAST CANCER |
Principal Investigator(s) 1. Fredrick Chite Asirwa 2. Mansoor Saleh Site(s) in Kenya 1. Aga Khan University, Nairobi (Nairobi City county) 2. International Cancer Institute (Uasin Gishu county) |
12-05-2023 |
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