Protocol 083: MK-5172A + Sofosbuvir +/- RBV in Cirrhotic GT3 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 Elbasvir/Grazoprevir (EBR/GZR) and Sofosbuvir (SOF) with and without Ribavirin (RBV) in Cirrhotic Subjects with Chronic HCV GT3 Infection.
IRAS ID
190856
Contact name
Graham Foster
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2015-003187-37
Duration of Study in the UK
1 years, 1 months, 21 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 (cirrhosis) and liver cancer. Current treatment regimens to treat HCV have improved in efficacy, tolerability and dosing schedules. However therapies for HCV genotype 3 (GT3) still remain suboptimal. HCV GT3 is the second most common genotype and globally affects approximately 54.3 million individuals. Patients with HCV GT3 infection are more likely to develop liver cancer therefore it is very important that a highly effective, well-tolerated therapy is found for HCV GT3 infected patients with cirrhosis.
Recent advances in HCV treatment has led to the approval of several medicines, known as direct acting antivirals (DAA). MK5172 and MK8742 are two DAAs developed by Merck for the treatment of HCV. Currently a number of treatments including a combination of the drugs Sofosbuvir (SOF) and Ribavarin (RBV), or SOF with the drug Daclatasvir (DCV) are used to treat HCV GT3. It has been proposed that MK5172 and MK8742 used as a fixed dose combination (MK5172A) with either SOF or both SOF and RBV could be a shorter, more effective and better tolerated treatment.
This study aims to test the effectiveness and safety of the combination of MK5172A and SOF with and without RBV in HCV GT3 infected patient with cirrhosis. The study will evaluate 8, 12, and 16 weeks of therapy, as previous studies have suggested that duration of therapy can impact effectiveness.
About 125 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 five treatment arms in a 1:1:1:1:1 ratio.
The study will take place at 15 UK hospitals.
REC name
Scotland A: Adults with Incapacity only
REC reference
15/SS/0186
Date of REC Opinion
4 Dec 2015
REC opinion
Further Information Favourable Opinion