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Page 13 of 59, showing 10 Applications out of 584 total, starting on record 121, ending on 130

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

121.

ECCT/23/04/02   Shigella 53G study in Kenya
    Safety and feasibility of a Shigella sonnei 53G controlled human infection model in Kenyan adults: a dose finding and dose verification study   
Principal Investigator(s)
1. Melissa Kapulu
2. Fredrick Sawe
Site(s) in Kenya
KEMRI-Wellcome Trust Research Programme (KWTRP) Centre for Geographic Medical Research - Coast (CGMRC), Kilifi, Kenya.
 
21-08-2024 View

122.

ECCT/24/07/05   Gates MRI TBV02-301
    A Phase 3, randomized, double-blind, placebo-controlled, multicenter, clinical trial to assess the prophylactic efficacy, safety, and immunogenicity of the investigational M72/AS01E-4 Mycobacterium tuberculosis (Mtb) vaccine when administered intramuscularly on a 0,1-month schedule to adolescents and adults.   
Principal Investigator(s)
1. Dr Bernhards Ogutu
Site(s) in Kenya
1. HOMA BAY COUNTY TEACHING AND REFERRAL HOSPITAL SITE (Homa Bay county)
 
20-08-2024 View

123.

ECCT/24/02/09   pionERA
    This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of   giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor   (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal   growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant   endocrine therapy.   
Principal Investigator(s)
1. Dr Sitna Ali
Site(s) in Kenya
University of Nairobi -Institute of Tropical and Infectious Diseases
 
04-08-2024 View

124.

ECCT/24/06/07   Gates MRI TBV02-301
    A Phase 3, randomized, double-blind, placebo-controlled, multicenter, clinical trial to assess the prophylactic efficacy, safety, and immunogenicity of the investigational M72/AS01E-4 Mycobacterium tuberculosis (Mtb) vaccine when administered intramuscularly on a 0,1-month schedule to adolescents and adults.   
Principal Investigator(s)
1. Charity Wambui Kanyoro
Site(s) in Kenya
1. Moi University Clinical Research Centre (Uasin Gishu county)
 
28-07-2024 View

125.

ECCT/23/06/09   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. Walter Otieno
2. Videlis Nduba
Site(s) in Kenya
1. Kombewa Clinical research Centre (Kisumu county)
2. KEMRI, Siaya Clinical Research Annex (Kisumu county)
 
19-07-2024 View

126.

ECCT/24/04/07   FORMATIVE-PEARLS TRIAL
    PEARLS FORMATIVE  (Preventing pre-eclampsia: Evaluating AspiRin Low-dose regimens following risk Screening)    
Principal Investigator(s)
1. Zahida Qureshi
2. Alfred Osoti
3. George Gwako
4. Rosa Chemwey
Site(s) in Kenya
1. Kakamega General County Teaching and Referral Hospital (Kakamega county)
2. Jaramogi Oginga Odinga Teaching and Referral Hospital (Kisumu county)
3. Kiambu Level 5 Hospital (Kiambu county)
4. Kisii Teaching and Referral Hospital (Kisii county)
5. Meru Teaching and Referral Hospital (Meru county)
 
05-07-2024 View

127.

ECCT/23/05/06   Sildenafil citrate to improve
    Sildenafil citrate to improve maternal and neonatal outcomes in low-resource settings:    a randomized feasibility trial   
Principal Investigator(s)
1. Nora Switchenko
Site(s) in Kenya
NAKURU COUNTY REFERRAL AND TEACHING HOSPITAL
 
05-07-2024 View

128.

ECCT/24/02/06   INAVO122
    A phase III, multicenter, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of Inavolisib in combination with Phesgo versus placebo in combination with Phesgo as maintenance therapy after first line induction therapy in participants with PIK3CA‐mutated HER2‐positive locally advanced or metastatic breast cancer   
Principal Investigator(s)
1. Dr Sitna Ali
Site(s) in Kenya
University of Nairobi -Institute of Tropical and Infectious Diseases
 
03-07-2024 View

129.

ECCT/24/04/02   PEARL RSVt Vaccine Study
    Phase III, randomized, observer-blind, placebo-controlled, multi-center, multinational study to evaluate the efficacy, immunogenicity, and safety of a Respiratory Syncytial Virus vaccine in infants and toddlers (PEARL   
Principal Investigator(s)
1. Dr Fredrick Kipyego Sawe
Site(s) in Kenya
1. Walter Reed Army Institute of Research -Kericho Site (Kericho county)
 
03-07-2024 View

130.

ECCT/24/06/01   Gates MRI TBV02-301
    A Phase 3, randomized, double-blind, placebo-controlled, multicenter, clinical trial to assess the prophylactic efficacy, safety, and immunogenicity of the investigational M72/AS01E-4 Mycobacterium tuberculosis (Mtb) vaccine when administered intramuscularly on a 0,1-month schedule to adolescents and adults.   
Principal Investigator(s)
1. Raymond Scott McClelland
Site(s) in Kenya
1. Pwani Research Centre (Mombasa county)
 
02-07-2024 View