Pharmacy and Poisons Board

Pharmacy and Poisons Board

Ensuring Safety, Quality and Efficacy of Medicines

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Page 1 of 12, showing 5 Applications out of 58 total, starting on record 1, ending on 5

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

1.

ECCT/17/09/01   HPTN 084
    HPTN 084:   A Phase 3 Double Blind Safety and Efficacy Study of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women         
Principal Investigator(s)
1. Dismas Odhiambo Oketch
Site(s) in Kenya
KISUMU CRS
 
Trial Status not yet recruiting
Protocol Date 02-03-2017
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2.

ECCT/17/09/02   WHO ACTION-I and ACTION-2 Trial
    A65913: A multi-country, multi-centre, two-arm, parallel, double-blind, placebo-controlled, randomized trial of antenatal corticosteroids for women at risk of imminent birth in the early preterm period in hospitals in low-resource countries to improve newborn outcomes       A65916: A multi-country, multi-centre, two-arm, parallel, double-blind, placebo-controlled, randomized trial of antenatal corticosteroids for women at risk of imminent birth in the late preterm period in hospitals in low-resource countries to improve newborn outcomes   
Principal Investigator(s)
1. Frederick Were
2. John Kinuthia
3. Zahida Parveen Qureshi
4. Zahida Parveen Qureshi
5. Zahida Parveen Qureshi
Site(s) in Kenya
1. Coast Provincial General Hospital (Mombasa Level 5 Hospital) (Mombasa county)
2. Kiambu Level 4 Hospital (Kiambu county)
3. Thika Level 5 Hospital (Kiambu county)
4. Nakuru Level 5 Hospital (Nakuru county)
 
Trial Status (not set!)
Protocol Date 06-02-2017
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3.

ECCT/17/06/01   MF/PM Phase III
    An Open Label, Phase III, Randomized Controlled, Multicentre Non-Inferiority Trial to Compare Efficacy and Safety of Miltefosine and Paromomycin with Sodium Stibogluconate and Paromomycin Combination for Treatment of Primary Visceral Leishmaniasis (VL) Patients in Eastern Africa   
Principal Investigator(s)
1. Jane Mbui
Site(s) in Kenya
1. Kimalel Health Centre (Baringo county)
2. Kacheliba sub-county hospital (West Pokot county)
 
Trial Status (not set!)
Protocol Date 20-02-2017
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4.

ECCT/17/08/02   IMPROVE (Improving PRegnancy Outcomes with intermittent PReVEntive treatment in Africa)
    IPTp with dihydroartemisinin-piperaquine and azithromycin for malaria, sexually transmitted and reproductive tract infections in pregnancy in high sulphadoxine-pyrimethamine resistance areas in Kenya, Malawi and Tanzania: an international multi-centre 3-arm placebo-controlled trial   
Principal Investigator(s)
1. Simon Kariuki
Site(s) in Kenya
1. Migori County Referral Hospital (Migori county)
2. Homa Bay County Referral Hospital (Homa Bay county)
3. Rongo Sub-County Hospital (Migori county)
4. Ahero Sub-County Hospital (Kisumu county)
5. Rabuor Sub-County Hospital (Kisumu county)
 
Trial Status recruiting
Protocol Date 01-05-2017
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5.

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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