MK-3682B in Hepatitis C Virus (HCV) Genotype 3 (GT3) participants
Research type
Research Study
Full title
A Phase 3 Clinical Study to Evaluate the Efficacy and Safety of the Combination Regimen of MK-3682B (Grazoprevir/Ruzasvir/Uprifosbuvir) in Participants with Chronic Hepatitis C Virus Genotype 3 Infection
IRAS ID
229631
Contact name
Kaushik Agarwal
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2017-001463-21
Duration of Study in the UK
1 years, 3 months, 25 days
Research summary
Hepatitis C is the inflammation of the liver caused by the hepatitis C virus (HCV) which can be divided into 6 genotypes (GTs/genetic constitution of an organism). It can cause both short and long-term hepatitis infection, ranging in severity from a mild illness lasting a few weeks to a serious, lifelong illness called chronic hepatitis C.
With the advent of oral Direct-Acting Antiviral (DAA) therapy, effective alternatives to the currently approved treatment regimens, involving interferon and ribavirin (RBV), are now available for subjects chronically infected with certain GTs. However, regimens vary for different HCV GTs and some subgroups, particularly GT3-infected patients, do not achieve optimal responses with the currently approved regimens, 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 cycle. Therapies can differ with respect to the number of DAAs in a regimen, doses, treatment duration, and/or inclusion of RBV. Developing a safe and effective single regimen would represent a significant improvement in HCV GT3 infection treatment.
MK-3682B (comprised of three potent DAA’s, MK-3682, MK-5172 and MK-8408) inhibit specific enzymes (proteins that accelerate chemical reactions) present during virus replication. It is proposed that this DAA combination could be a highly effective treatment regimen for GT3-infected patients.
This study will last approximately 62 weeks and evaluate the efficacy and safety of this combination regimen to treat subjects with HCV GT3 infection. Approximately 426 subjects older than 18 will be enrolled to receive 12 weeks of treatment with MK-3682B either in an Immediate Treatment Group (Arm 1) or in a Deferred Treatment Group (12 weeks placebo, followed by open-label treatment with MK-3682B) (Arm 2).
The study is funded by Merck Sharp & Dohme Limited and will take place at 5 study centres in the UK.
REC name
London - Chelsea Research Ethics Committee
REC reference
17/LO/1091
Date of REC Opinion
20 Jul 2017
REC opinion
Favourable Opinion