K-5172+ MK-8742+ Ribavirin in Treating Subjects with Genotype 2,4,5, a
Research type
Research Study
Full title
A Phase II Clinical Trial to Study the Efficacy and Safety of a combination regimen of MK-5172 and MK-8742 with Ribavirin (RBV) in Subjects with Chronic Hepatitis C Genotype 2,4,5 and 6 Infection
IRAS ID
135371
Contact name
Ashley Brown
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp.
Eudract number
2013-002169-21
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
Hepatitis C infection is a global health challenge affecting an estimated 170 million people. The majority, 55 to 85% of subjects, go on to develop a chronic long-lasting, (more than 6 months) hepatitis C virus infection.
Currently Hepatitis C treatment consists of a 24 week treatment with pegylated interferon (peg-IFN) and ribavirin (RBV) to treat all genotypes. In Genotype 2 patients the SVR rate is about 80%. However many patients can not tolerate the side effects of peg-IFN and the duration of treatment, therefore a shorter duration and interferon free treatment would be a significant advantage to these patients.
This study will look at 2 experimental drugs MK-5172 and MK-8742 in combination with RBV. MK-5172 is a very potent protease inhibitor which blocks a key viral protein. MK-8742 is an inhibitor which blocks a key enzyme involved in virus replication. RBV helps these 2 experimental drugs to block the viral genetic material from duplicating.
The MK-5172-047 study is designed to look at the effectiveness of MK-5172 in combination with MK-8742 and RBV for 12 weeks to assess the virus levels in the blood after 12 weeks of treatment.
Approximately 30 patients with Hepatitis C, Genotype 2, who have not previously received treatment, will be enrolled into the study. Patients will receive MK-5172 + MK-8742 + RBV for 12 weeks and then be followed up for 24 weeks.
The patients will be in the study for a total of 42.5 weeks from the time informed consent is signed through to final contact.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
13/EE/0257
Date of REC Opinion
28 Aug 2013
REC opinion
Further Information Favourable Opinion