Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Treatment-Naïve Subjects with Chronic HCV who are on Opiate Substitution Therapy.
- Conditions
- Hepatitis CTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2014-000343-32-ES
- Lead Sponsor
- Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- Not specified
- Target Recruitment
- 300
-You are greater than or equal to 18 years of age.
-You have chronic genotype 1, 4, 5, or 6 Hepatitis C virus.
-You must be on opiate substitution therapy (OST), have kept at least 80% of scheduled appointments while on OST, and not missed any scheduled appointments between screening and study entry
-You have had a liver biopsy, Fibroscan, or Fibrotest to check for cirrhosis or no cirrhosis.
-You are treatment naïve to all HCV treatment
-You may be co-infected with HIV
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 300
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
-You have signs of decompensated liver disease.
-You are coinfected with Hepatitis B virus.
-You have signs of hepatocellular carcinoma or history of malignancy.
-You are taking or plan to take any medication not allowed for this study.
-You have a history of, or signs of, chronic hepatitis not caused by hepatitis C virus.
-You have an exclusionary laboratory value
-If you have HIV, you use HIV drugs other than a dual NNRTI backbone of tenofovir or abacavir and either emtricitabine or lamivudine PLUS raltegravir [or dolutegravir or rilpivine]
-You have a history of opportunistic infection in the preceding 6 months prior to screening.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main Objective: -To evaluate the efficacy of MK-5172 in combination with MK-8742 as assessed by the proportion of subjects achieving SVR12 (Sustained Virologic Response 12 weeks after the end of all study therapy), defined as HCV RNA <LLOQ (either TD[u] or TND) 12 weeks after the end of all study therapy.<br> -To evaluate the safety and tolerability of MK-5172 in combination with MK-8742.<br> ;Secondary Objective: To evaluate the efficacy of MK-5172 in combination with MK-8742 as assessed by the proportion of subjects achieving: SVR24 (Sustained Virologic Response 24 weeks after the end of all study therapy), defined as HCV RNA <LLOQ (either TD(u) or TND) 24 weeks after the end of all study therapy.;Primary end point(s): The SVR12 rate of subjects enrolled.;Timepoint(s) of evaluation of this end point: SVR12
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The SVR24 rate of subjects enrolled.;Timepoint(s) of evaluation of this end point: SVR24