Clinical Trial Applications - Approved: Filter, Search, and view applications
| # | Protocol No | Study Title | Investigator(s) & Site(s) | Date Approved | |
|---|---|---|---|---|---|
351. |
ECCT/22/05/03 | Anti-malaria MAb in Kenyan chi Safety and Efficacy of L9LS, a Human Monoclonal Antibody Against Plasmodium falciparum, in an Age De-Escalation, Dose-Escalation Trial and a Randomized, Placebo-Controlled, Double-Blind Trial of Children in Western Kenya |
Principal Investigator(s) 1. Titus Kwambai 2. Laura Steinhardt 3. Robert A Seder Site(s) in Kenya 1. Siaya County Referral Hospital (Siaya county) 2. Kogelo Health Center (Siaya county) |
08-08-2022 |
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352. |
ECCT/22/06/01 | The INSIGHT cohort A cohort for evaluation of open-label PrEP delivery and PrEP preferences among African women |
Principal Investigator(s) 1. Elizabeth Anne Bukusi Site(s) in Kenya KEMRI RCTP, LUMUMBA SUBCOUNTY HOSPITAL |
16-08-2022 |
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353. |
ECCT/22/06/02 | Mitapivat - AG348-C-020 A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Mitapivat in Subjects With Sickle Cell Disease. |
Principal Investigator(s) 1. Lucas Otieno Tina 2. Bernhards Ragama Ogutu 3. Prof Jessie N Githanga 4. Videlis N Nduba 5. Janet N/A Oyieko 6. Allan Godfrey Otieno Site(s) in Kenya 1. Victoria Biomedical Research Institute (Kisumu county) 2. Strathmore University Medical Centre (Nairobi City county) 3. KEMRI/CRDR (Nairobi City county) 4. KEMRI Siaya Clinical Research Annex (Siaya county) 5. Gertrude’s Children’s Hospital (Nairobi City county) 6. KEMRI Kondele Children\'s Hospital (Kisumu county) 7. Kombewa Clinical Research Centre (Kisumu county) |
06-09-2022 |
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354. |
ECCT/22/07/01 | GBT021601-021 Study A Phase 2/3 Randomized, Multicenter Study of GBT021601 Administered Orally to Participants with Sickle Cell Disease and an Open-Label Pharmacokinetics Study in Pediatric Participants with Sickle Cell Disease |
Principal Investigator(s) 1. Jessie Nyokabi Githanga 2. Berhnards Ragama Ogutu 3. Videlis Nduba 4. Berhnards Ragama Ogutu Site(s) in Kenya 1. Gertude\'s Children\'s Hospital (Nairobi City county) 2. CENTER FOR RESEARCH IN THERAPEUTIC SCIENCES-STRATHMORE UNIVERSITY MEDICAL CENTER (CREATES (Nairobi City county) 3. / KENYA MEDICAL RESEARCH INSTITUTE- CENTER FOR RESPIRATORY DISEASE RESEARCH(CRDR) (Nairobi City county) 4. KENYA MEDICAL RESEARCH INSTITUTE- SIAYA COUNTY REFERAL HOSPITAL (Siaya county) |
17-10-2022 |
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355. |
ECCT/22/08/01 | GBT Open Label inclacumab Ph3 An Open-Label Extension Study to Evaluate the Long-Term Safety of Inclacumab Administered to Participants with Sickle Cell Disease Who Have Participated in an Inclacumab Clinical Trial |
Principal Investigator(s) 1. Prof Jessie N Githanga 2. Bernhards Ragama Ogutu 3. Fredrick Asirwa Chite 4. Videlis N Nduba Site(s) in Kenya 1. Gertrude’s Children’s Hospital (Nairobi City county) 2. Strathmore University Medical Centre (Nairobi City county) 3. International Cancer Institute (ICI)-Eldoret (Uasin Gishu county) 4. KEMRI/CRDR (Nairobi City county) 5. KEMRI Siaya Clinical Research Annex (Siaya county) |
19-10-2022 |
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356. |
ECCT/22/08/02 | AIM-LVRNA009-II_III-01 A Global Multi-center, Randomized, Blinded, Placebo-controlled Phase 2/3 Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (LVRNA009) for the Prevention of COVID-19 in Participants Aged 18 Years and Olde |
Principal Investigator(s) 1. Bernhards Ogutu 2. Lucas Otieno 3. Videlis Nduba 4. Bernhards Ogutu 5. Jacqueline Mirera 6. Jacqueline Mirera Site(s) in Kenya 1. Siaya Clinical Trials Unit (Siaya county) 2. Homa Bay Clinical Trials Unit (Homa Bay county) 3. Ahero Clinical Trials Unit (Kisumu county) 4. CREA-N Machakos (Machakos county) 5. CREA-N Nakuru (Nakuru county) 6. Victoria Biomedical Research Institue (Kisumu county) |
22-11-2022 |
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357. |
ECCT/22/08/03 | NeoSep1 An open-label randomised controlled trial comparing novel combination and currently used antibiotic regimens for the empiric treatment of clinically diagnosed neonatal sepsis with a run-in confirmatory pharmacokinetic phase. |
Principal Investigator(s) 1. Christina Wesonga Obiero 2. James Alexander Berkley Site(s) in Kenya 1. Kilifi County Hospital, KEMRI- Wellcome Trust Research Programme (KWTRP) (Kilifi county) |
21-12-2022 |
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358. |
ECCT/22/08/04 | Protocol H06_01TP A staged Phase I/II observer-blind, randomised, controlled, multi-country study to evaluate the safety, reactogenicity, and immune responses to the GVGH altSonflex1-2-3 vaccine against S. sonnei and S. flexneri, serotypes 1b, 2a, and 3a, in adults in Europe (Stage 1) followed by age de-escalation from adults to children and infants, and dose-finding in infants in Africa (Stage 2) |
Principal Investigator(s) 1. Deborah Chepngeno Langat Langat Site(s) in Kenya KEMRI WRP CRC KERICHO |
23-11-2022 |
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359. |
ECCT/22/09/01 | Agios Study A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Mitapivat in Subjects With Sickle Cell Disease. Mitapivat - AG348-C-020 |
Principal Investigator(s) 1. Bernhards Ragama Ogutu 2. Godfrey Allan Otieno Site(s) in Kenya 1. Strathmore University Medical Centre (Nairobi City county) 2. Victoria Biomedical Research Institute (Kisumu county) 3. KEMRI/CRDR (Nairobi City county) 4. KEMRI Siaya Clinical Research Annex (Siaya county) 5. Gertrude’s Children’s Hospital (Nairobi City county) 6. KEMRI Kondele Children\'s Hospital (Kisumu county) 7. Kombewa Clinical Research Centre (Kisumu county) |
20-12-2022 |
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360. |
ECCT/22/09/02 | LISA Trial Levonorgestrel intrauterine system effects on hemoglobin and serum ferritin among anemic women in Kenya: An open label randomized trial to compare with an oral contraceptive regimen that provides supplemental ferrous fumarate tablets |
Principal Investigator(s) 1. Faith Mugure Thuita Site(s) in Kenya Kangemi Health Centre |
23-02-2023 |
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