MK-5172/MK-3682 with MK-8742 or MK-8408 in HCV GT1, GT2, and GT4 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 GT4 Infection
IRAS ID
163708
Contact name
Joan Butterton
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,Inc.
Eudract number
2014-003304-73
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 3 months, 18 days
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 antiviral (DAA) drugs developed by Merck: MK-5172 and MK-3682 with either MK8742 or MK8408. Previous studies in patients with HCV infections have demonstrated that combinations of similar complementary DAAs, which have difference mechanisms of action, can result in improved effectiveness and or/comparable effectiveness but with shorter duration of treatment. In addition, these DAA combinations can eliminate pegylated interferon and ribavirin from treatment regimens, together with their associated toxicities.
This is an open-label study. The study will enrol subjects naive to HCV treatment with HCV GT1/GT2/GT4 infection, including non-cirrhotic and cirrhotic subjects, and HCV mono-infected and HCV/HIV co-infected subjects. Part A of the study will test the effectiveness and safety of MK-3682 + MK-5172 with either MK-8742 or MK-8408. The UK will only take part in Part B. The dose of MK-3682 to test in Part B has been preselected and Part B only includes the combination of MK-3682 + MK-5172 with MK-8408. The efficacy and safety of the aforementioned treatment regimen with a duration of either 6 or 8 weeks will be tested in Part B. Retreatment will be offered to patients who do not maintain undetectable virus levels after completing treatment.
Patients enrolled into the main study will visit the clinic about 13-14 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 retreated.
About 480 subjects will take part in this study, with 23 from across 4 UK hospitals. The study is funded by Merck Sharp & Dohme Limited.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
15/EE/0100
Date of REC Opinion
12 May 2015
REC opinion
Further Information Favourable Opinion