MK-5172 + MK-8742 in HCV-infected subjects with hepatic insufficiency (CP-B)
Research type
Research Study
Full title
A Phase II/III Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-8742 in Subjects with Chronic Hepatitis C Virus Infection with Advanced Cirrhosis and Child-Pugh (CP)-B Hepatic Insufficiency.
IRAS ID
167550
Contact name
Edgar Charles
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidary of Merck & Co.
Eudract number
2014-000672-25
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 10 months, 28 days
Research summary
Hepatitis C virus (HCV) is a leading cause of liver disease. HCV is transmitted by exposure to contaminated blood and approximately 130-170 million people worldwide are chronically infected with HCV. Long term complications of chronic HCV infection, which develop over several years, include cirrhosis, end stage liver disease and liver cancer.
Research into treatments for HCV has resulted in approval of several medicines, known as direct acting antivirals (DAA). DAAs vary in their ability to clear the virus depending on the HCV genotype, patient's cirrhotic status and whether a patient has responded to treatment in the past. Therefore, it is usually necessary to use DAAs in combination with other licenced drugs (peginterferon and ribavirin) to increase the effectiveness of the treatment. For patients with moderate to advanced cirrhosis, interferon containing regimens are not recommended due to poor tolerability and ineffectiveness. There is a clear unmet need for improved HCV treatments in this patient population to eradicate the virus, leading to improved liver function and ultimately, patient survival.
MK-5172 and MK-8742 are two DAAs developed by Merck for the treatment of HCV which in combination have been shown to rapidly clear the HCV virus from the blood after 12 weeks of treatment.
This trial aims to study the effectiveness and safety of MK-5172 in combination with MK-8742 taken for 12 weeks in HCV-infected subjects who have cirrhosis and moderately impaired liver function. Efficacy will be determined by measuring the levels of virus in patients 12 weeks after completing treatment, known as sustained virological response (SVR) 12.
This is a non-randomised, historical-controlled, multi-site, open-label Phase 2/3 study.
About 170 patients will take part in this study.
Each subject will participate in the trial for approximately 44.5 weeks.
The study will take place at 1 UK hospital site and is funded by Merck Sharp & Dohme Limited.
REC name
London - City & East Research Ethics Committee
REC reference
15/LO/0007
Date of REC Opinion
22 Jan 2015
REC opinion
Favourable Opinion