Clinical Trial Applications - Approved: Filter, Search, and view applications
| # | Protocol No | Study Title | Investigator(s) & Site(s) | Date Approved | |
|---|---|---|---|---|---|
261. |
ECCT/20/11/02 | IAVI C100 Safety and Pharmacokinetics of the Combination Broadly Neutralizing Antibodies, 3BNC117-LS-J and 10-1074-LS-J, in Healthy American and African Adults (IAVI C100) |
Principal Investigator(s) 1. Nelly Mugo Site(s) in Kenya 1. Partners in Health Research and Development (PHRD) – CCR-KEMRI (Kiambu county) 2. Kenya AIDS Vaccine Initiative- Institute of Clinical Research (KAVI-ICR) (Nairobi City county) |
03-03-2021 |
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262. |
ECCT/20/11/05 | HOPE Kids 2 A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Voxelotor (GBT440) in Pediatric Participants with Sickle Cell Disease (HOPE Kids 2) |
Principal Investigator(s) 1. Jessie Nyokabi Githanga 2. Videlis Nduba 3. Bernhards Ragama Ogutu Site(s) in Kenya 1. Gertrude’s Children’s Hospital (Nairobi City county) 2. KEMRI/CRDR Clinical Research Annex (Nairobi City county) 3. Strathmore University Medical Centre (Nairobi City county) 4. KEMRI/CRDR Siaya (Siaya county) |
03-03-2021 |
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263. |
ECCT/20/12/03 | CALINA STUDY A multicenter, open-label, single-arm study to evaluate the PK, safety, tolerability and efficacy of a new artemether-lumefantrine (2.5 mg:30 mg) dispersible tablet in the treatment of infants and neonates <5 kg body weight with acute uncomplicated Plasmodium falciparum malaria. Study number: CCOA566B2307 |
Principal Investigator(s) 1. Benhards Ragama Ogutu Site(s) in Kenya KEMRI-Centre for Clinical Research (CCR) |
08-03-2021 |
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264. |
ECCT/21/02/03 | VAC078 A Phase III randomized, controlled, multi-centre trial to evaluate the efficacy of the R21/Matrix-M vaccine in African children against clinical malaria. |
Principal Investigator(s) 1. Mainga Patience Mayeso Hamaluba 2. Jean Bosco Ouedraogo 3. Halidou Tinto 4. Alassane Dicko 5. Ally Olotu Site(s) in Kenya KEMRI Wellcome Trust Research Programme |
02-04-2021 |
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265. |
ECCT/21/02/02 | RESHAPE PROSPECTIVE NON-INTERVENTIONAL MULTI-CENTER STUDY EVALUATING BLEEDING INCIDENCE AND HEALTH-RELATED QUALITY OF LIFE IN PATIENTS WITH HEMOPHILIA A WITH INHIBITORS AND NON-INHIBITORS TREATED WITH EMICIZUMAB AND OTHER HEMOPHILIA TREATMENTS IN A REAL-LIFE SETTING |
Principal Investigator(s) 1. Festus Njuguna Site(s) in Kenya Moi Teaching and Referral Hospital |
12-05-2021 |
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266. |
ECCT/21/02/04 | GASTROSAM GASTROSAM Gastroenteritis: Rehydration of children with severe acute malnutrition |
Principal Investigator(s) 1. Professor Kathryn Maitland Site(s) in Kenya Kilifi County Hospital |
13-05-2021 |
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267. |
ECCT/21/03/01 | Recombinant COVID-19 vaccine A global multicenter, randomized, double-blind, placebo-controlled, phase III clinical trial to evaluate the efficacy, safety, and immunogenicity of recombinant COVID-19 vaccine (Sf9 cells), for the prevention of COVID-19 in adults aged 18 years and older |
Principal Investigator(s) 1. Walter Jaoko Jaoko Site(s) in Kenya KAVI-institute of Clinical Research |
13-05-2021 |
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268. |
ECCT/21/03/02 | PB-SAM Pancreatic Enzymes and Bile Acids: A Non-Antibiotic approach to Treat Intestinal Dysbiosis in Acutely Ill Severely Malnourished Children. |
Principal Investigator(s) 1. Robert Bandsma Site(s) in Kenya 1. Kilifi County Hospital (Kilifi county) 2. Coast General Hospital (Mombasa county) 3. Mbagathi Hospital (Nairobi City county) 4. Migori County Hospital (Migori county) |
08-06-2021 |
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269. |
ECCT/21/03/07 | CHIMES AN OPEN-LABEL, MULTICENTER STUDY TO ASSESS DISEASE ACTIVITY AND BIOMARKERS OF NEURONAL DAMAGE IN MINORITY PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS RECEIVING TREATMENT WITH OCRELIZUMAB |
Principal Investigator(s) 1. Mansoor Saleh Site(s) in Kenya Aga Khan University, Nairobi |
08-06-2021 |
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270. |
ECCT/20/12/01 | KU ‘TIBA VENT\' Phase I/II, Open Label Randomized Controlled Trial Evaluating Safety of 'KU TIBA VENT" For Mechanical Ventilation in Patients With Respiratory Failure During Weaning Phase Abstract KU TIBA VENT There is ongoing pandemic caused by SARS-Cov-2, commonly referred to us COVID-19 that started in China in December 2019. The patients develop acute respiratory failure requiring machine assisted breathing. However, due to the huge numbers affected patients, the demand for mechanical ventilators outstrip supply worldwide. This is especially so in Kenya with poor health systems. In response to the increased demand for mechanical ventilators, a group of students plus their lecturer mentors at Kenyatta University responded by designing and producing a ‘TIBA VENT” from locally available materials. The design and production processes have been evaluated by the Kenya Bureau of Standards and found to be in conformity with the countries standards. We have designed a protocol to guide clinical validation before registration by Pharmacy and Poisons Board as part of requirement for commercialization. The main objective of this clinical validation is to assess the dependability and reliability of the device when connected to patients in the intensive care Unit. The secondary end points are to assess the functionality of the control variables, the trigger settings as well as user concerns to facilitate design modifications before roll out. The clinical validation will be done at Kenyatta University Teaching, Research and Referral Hospital (KUTRRH). This is a phase II of study with expected duration of 14 days and enrolling at least 4 patients. The sponsor for the study is the Kenyatta University. The information obtained will assist in design modifications before commercialization. This is an example of homegrown innovation. |
Principal Investigator(s) 1. Gordon Oluoch Ogweno Site(s) in Kenya Kenyatta University Teaching Research and Referral Hospital (KUTRRH) |
09-06-2021 |
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