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Page 13 of 25, showing 10 Applications out of 243 total, starting on record 121, ending on 130

# Protocol No Study Title Investigator(s) & Site(s) Date Approved

121.

ECCT/22/10/02   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. Janet N Oyieko
Site(s) in Kenya
1. Kombewa Clinical Research Centre (Kisumu 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. Strathmore University Medical Centre (Nairobi City county)
 
10-02-2023 View

122.

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 View

123.

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 View

124.

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 View

125.

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 View

126.

ECCT/22/05/01   VICTORION-2 PREVENT
    A randomized, double-blind, placebo-controlled, multicenter trial, assessing the impact of inclisiran on major adverse cardiovascular events in participants with   established cardiovascular disease   
Principal Investigator(s)
1. Anthony Gikonyo
2. ELIJAH SAMMY NYAINDA OGOLA
Site(s) in Kenya
1. The Karen Hospital (Nairobi City county)
2. Centre for research in Therapeutic Sciences (CREATES (Nairobi City county)
 
05-10-2022 View

127.

ECCT/22/05/02   BREATHER Plus
        A randomised open-label 2-arm, 96-week trial evaluating the efficacy, safety and acceptability of short cycle (five days on, two days off) dolutegravir/tenofovir-based triple antiretroviral therapy (ART) compared to daily dolutegravir/tenofovir-based triple ART in virologically suppressed HIV-infected adolescents aged 12 to 19 years of age in sub-Saharan Africa   
Principal Investigator(s)
1. Abraham Siika
Site(s) in Kenya
Moi University Clinical Research Centre
 
25-09-2022 View

128.

ECCT/21/09/01   Kuwa Free! - Live free!
    Co-benefits of co-delivery of long-acting antiretrovirals and contraceptives   
Principal Investigator(s)
1. Rena Patel
2. Edwin Were
Site(s) in Kenya
Moi Teaching and Referral Hospital
 
16-09-2022 View

129.

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 View

130.

ECCT/22/01/01   ASTEFANIA
    A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF ADJUVANT ATEZOLIZUMAB OR PLACEBO AND TRASTUZUMAB EMTANSINE FOR HER2-POSITIVE BREAST CANCER AT HIGH RISK OF RECURRENCE FOLLOWING PREOPERATIVE THERAPY   
Principal Investigator(s)
1. Mansoor Saleh
2. Fredrick Chite Asirwa
Site(s) in Kenya
1. Aga Khan University, Nairobi (Nairobi City county)
2. International Cancer Institute (Uasin Gishu county)
 
21-07-2022 View