MK-3682 + Ruzasvir for 12 weeks in Subjects with HCV GT1-6 Infection
Research type
Research Study
Full title
A Phase 2, Open-Label Clinical Trial to Study the Efficacy and Safety of 12 weeks of the Combination Regimen of MK-3682 + Ruzasvir in Subjects with Chronic Hepatitis C Virus (HCV) Genotype 1, 2, 3, 4, 5 or 6 Infection
IRAS ID
215378
Contact name
Kaushik Agarwal
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2016-003227-37
Duration of Study in the UK
3 years, 11 months, 12 days
Research summary
Hepatitis C virus (HCV) infection is among the most common of all chronic liver diseases. HCV predominantly affects liver cells and causes the liver to become inflamed and damaged. This can lead to cirrhosis (scarring of the liver) and liver cancer, and patients may then need a liver transplant.
There are 6 major genotypes (genetic variations) of HCV; there is no current standard of care treatment for all genotypes. A therapy that avoids the costs and delays of having to assess the HCV genotype would facilitate therapy and reduce treatment cost.
With the advent of oral Direct-Acting Antiviral (DAA) therapy, effective interferon and ribavirin (RBV)-free combination regimens are now available for subjects chronically infected with certain GTs. However, those regimens vary for different HCV GTs and some subgroups of subjects do not achieve optimal responses, thus leading to complexity of treatment.
Highly efficacious treatments for HCV infection require combinations of DAAs that simultaneously attack multiple points of the viral replication (formation of biological viruses during the infection cycle). Effective therapies can differ with respect to the number of DAAs included in a regimen, doses, treatment duration, and/or inclusion of RBV. Developing a safe and effective, single regimen in all patient populations would represent a substantial advance in treating HCV infection.
This study will last approximately 46 weeks and evaluate the efficacy and safety of a novel 2-drug combination regimen to treat subjects with chronic HCV GT1-6 infection. Approximately 250 subjects older than 18 will be enrolled to receive 12 weeks of treatment with MK-3682 (450 mg) + MK-8408 (180 mg) with target enrolment based on GT. The combination of these 2 DAAs may be a highly effective regimen.
The study is funded by Merck Sharp & Dohme Limited and will take place at 4 study centres in the UK.
REC name
London - Dulwich Research Ethics Committee
REC reference
16/LO/1984
Date of REC Opinion
4 Jan 2017
REC opinion
Further Information Favourable Opinion