MK-5172/MK-3682 with MK-8742 or MK-8408 in HCV GT1, GT2 and GT3 Infected Subjects
Research type
Research Study
Full title
A Phase II, Randomized, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-3682 with Either MK-8742 or MK-8408 in Subjects with Chronic HCV GT1, GT2 and GT3 Infection
IRAS ID
163709
Contact name
Joan Butterton
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc.
Eudract number
2014-003347-35
Research summary
Chronic Hepatitis C virus (HCV) is a leading cause of liver disease. This phase II study will evaluate the safety and effectiveness of two HCV treatment regimens consisting of combinations of three direct acting anti-viral (DAA) drugs developed by Merck: MK-5172 and MK-3682 with either MK-8742 or MK-8408. Previous studies in patients with HCV infections have demonstrated that incremental addition of such complementary DAAs to a regimen can result in improved effectiveness and or/comparable effectiveness but with shorter duration of treatment and/or elimination of a current standard of care treatment (weekly pegylated-interferon(peg-IFN) injections plus ribavirin(RBV)(PR)) which has associated toxicity.
This study is a three-part, open-label study. Following a pilot phase, the main phase of the study will enrol subjects with GT1/GT2/GT3 infection, including prior HCV treatment-naïve and treatment experienced subjects, non-cirrhotic and cirrhotic subjects, and HCV mono-infected and HCV/HIV co-infected subjects. All subjects will be randomly assigned to groups to receive one of the two treatment regimens for 4, 6 or 8 weeks. There will also be a 12 week retreatment phase for subjects that do not achieve the criteria for treatment success but have not shown treatment failure or discontinuation from their original therapy.
Patients enrolled into the main study will visit the clinic about 14-16 times plus phone calls over an 8 month period. Patients will be monitored for their Hepatitis C and general health and asked to provide blood samples throughout the study. There will be an additional 13 clinic visits for patients who are allowed to begin retreatment.
About 460 subjects will take part in this study, with 20 from the UK allocated to one of 4 UK hospitals. One of the 4 sites will participate in Part A. Only HCV GT3 patients will be included from the UK.
The study is funded by Merck Sharp & Dohme Limited.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
14/EE/1165
Date of REC Opinion
22 Oct 2014
REC opinion
Further Information Favourable Opinion