Pharmacy and Poisons Board

Pharmacy and Poisons Board

Ensuring Safety, Quality and Efficacy of Medicines

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Page 4 of 38, showing 5 Applications out of 190 total, starting on record 16, ending on 20

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

16.

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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17.

ECCT/17/05/04   Ad26.Mos4.HIV Prime/Ad26.Mos4.HIV with Clade C gp140 plus adjuvant +/- Mosaic boost
    A randomized, parallel-group, placebo-controlled, double-blind Phase 1/2a study in healthy HIV-uninfected adults to assess safety/tolerability and immunogenicity of 2 different prime/boost regimens: priming with tetravalent Ad26.Mos4.HIV and boosting with tetravalent Ad26.Mos4.HIV and either Clade C gp140 plus adjuvant OR a combination of Mosaic and Clade C gp140 plus adjuvant   
Principal Investigator(s)
1. Josphat Kosgei
Site(s) in Kenya
KEMRI WALTER REED KERICHO
 
Trial Status In follow-up
Protocol Date 02-12-2016
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18.

ECCT/17/08/01   A trial to compare the safety and immune response of the normal full and reduced doses of yellow fever vaccines in Kenyan adults
    A Phase IV randomized, double blinded non-inferiority trial on the immunogenicity and safety of fractional doses of yellow fever vaccines.   
Principal Investigator(s)
1. Philip Bejon
Site(s) in Kenya
KEMRI Kilifi
 
Trial Status In follow-up
Protocol Date 20-04-2017
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19.

ECCT/17/05/02   The Anza Mapema Study
    Expanding test and treat for HIV prevention in MSM in Kisumu, Kenya: The Anza Mapema Study   
Principal Investigator(s)
1. Fredrick Odhiambo Otieno
Site(s) in Kenya
Anza Mapema Study Clinic
 
Trial Status recruiting
Protocol Date 20-09-2016
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20.

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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