Pharmacy and Poisons Board

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Ensuring Safety, Quality and Efficacy of Medicines

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Page 4 of 38, showing 5 Applications out of 186 total, starting on record 16, ending on 20

# Protocol No Study Title Investigator(s) & Site(s) Application Status

16.

ECCT/17/03/02   The Edoxaban Hokusai VTE PEDIATRICS Study
    A PHASE 3, OPEN-LABEL, RANDOMIZED, MULTICENTER, CONTROLLED TRIAL TO EVALUATE THE PHARMACOKINETICS AND PHARMACODYNAMICS OF EDOXABAN AND TO COMPARE THE EFFICACY AND SAFETY OF EDOXABAN WITH STANDARD OF CARE ANTICOAGULANT THERAPY IN PEDIATRIC SUBJECTS FROM BIRTH TO LESS THAN 18 YEARS OF AGE WITH CONFIRMED VENOUS THROMBOEMBOLISM (VTE)   
Principal Investigator(s)
1. Bernhards Ragama Ogutu Ragama
Site(s) in Kenya
1. Gertrudes Hospital (Nairobi City county)
2. Mater Hospital (Nairobi City county)
 
Trial Status (not set!)
Protocol Date 16-04-2016
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17.

ECCT/17/03/05   HOPE Sickle Cell Disease Clinical Study
    A Phase 3, Double-blind, Randomized, Placebo-controlled, Multicenter Study of GBT440 Administered Orally to Patients With Sickle Cell Disease   
Principal Investigator(s)
1. Benhards Ogutu
2. Videlis Nduba
3. Jessie Nyokabi Githanga
Site(s) in Kenya
1. Gertrude\'s Children\'s Hospital (Nairobi City county)
2. Strathmore University Medical Center (Nairobi City county)
3. KEMRI CRDR Clinical Research clinic at Chandaria Health Center (Nairobi City county)
4. KEMRI Kondele Childrens Hospital Center for Clinical Research (Kisumu county)
5. KEMRI Clinical Research Center at Siaya County Referral Hospital (Siaya county)
 
Trial Status recruiting
Protocol Date 09-11-2016
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18.

ECCT/17/03/01   The POWER cohort
    A cohort for evaluation of open-label PrEP delivery among Kenyan and South African women   
Principal Investigator(s)
1. Dr. Stella Njuguna
Site(s) in Kenya
1. Jaramogi Oginga Odinga Teaching and Referral Hospital. (Kisumu county)
 
Trial Status (not set!)
Protocol Date 13-10-2017
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19.

ECCT/17/08/04   P1081
    A PHASE IV RANDOMIZED TRIAL TO EVALUATE THE VIROLOGIC RESPONSE AND PHARMACOKINETICS OF TWO DIFFERENT POTENT REGIMENS IN HIV INFECTED WOMEN INITIATING TRIPLE ANTIRETROVIRAL REGIMENS BETWEEN 28 AND 36 WEEKS OF PREGNANCY FOR THE PREVENTION OF MOTHER-TO-CHILD TRANSMISSION:    NICHD P1081   
Principal Investigator(s)
1. FREDRICK KIPYEGON SAWE
Site(s) in Kenya
Kenya Medical Research Institute Walter Reed Project Clinical Research Centre.
 
Trial Status (not set!)
Protocol Date 02-04-2015
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20.

ECCT/17/05/01   Multicenter Study of the Accuracy of the BD MAX™MDR-TB Assay
    Multicenter Study of the Accuracy of the BD MAX™MDR-TB Assay for Detection of M. tuberculosis Complex and Mutations Associated with Resistance to Rifampin or Isoniazid   
Principal Investigator(s)
1. SAMUEL GURRION OUMA
Site(s) in Kenya
KENYA MEDICAL RESEARCH INSTITIUTE
 
Trial Status (not set!)
Protocol Date 04-01-2016
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