MK-3682B in Hepatitis C (GT1 or GT3) patients who have failed a DAA
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-3682B (MK-5172 + MK-3682 + MK-8408 Fixed Dose Combination (FDC)) in Subjects with Chronic HCV GT1 or GT3 Infection who have failed a Direct Acting Antiviral Regimen
IRAS ID
192116
Contact name
Kaushik Agarwal
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc
Eudract number
2015-001483-19
Duration of Study in the UK
1 years, 0 months, 20 days
Research summary
Hepatitis C virus (HCV) is a leading cause of liver disease. HCV is transmitted by exposure to contaminated blood. Long term complications of chronic HCV infection include liver disease and liver cancer. There have been six different types of HCV genotype (HCV with a slightly different genetic makeup). These are known as GT1-GT6. GT1 and GT3 are the predominant genotypes world-wide.
Recent advances in HCV treatment has led to the approval of several medicines, known as direct acting antivirals (DAA). Although current DAA regimens have improved efficacy compared with earlier therapies, virologic failures still occur and efficacy with current DAA regimens remains suboptimal among important segments of the HCV infected population, including cirrhotic patients.
This study will evaluate the effectiveness of a drug called MK-3682B in treating patients with HCV GT1 and GT3 who have previously failed treatment with DAA regimens. MK-3682B is a product made up of 3 new drugs which are currently being developed by MSD: MK-5172, MK-3682 and MK-8408.
This study aims to test the effectiveness and safety of the combination of MK-3682B with and without ribavarin (RBV) in HCV GT1 and GT3 infected patient with cirrhosis or without cirrhosis. The study will evaluate 16 and 24 weeks of therapy, as previous studies have suggested that duration of therapy can impact effectiveness.
About 200 patients will take part in this study to test the efficacy of treatment as determined by virus levels in the blood 12 weeks after completing treatment. Eligible patients will be randomised into one of six treatment arms.
The study will take place at 3 UK hospitals.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
15/YH/0490
Date of REC Opinion
27 Nov 2015
REC opinion
Further Information Favourable Opinion