A Phase III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Treatment-Naïve Subjects with Chronic HCV GT1, GT4, and GT6 Infection who are on Opiate Substitution Therapy.

Phase 1

• Conditions: Hepatitis C; MedDRA version: 20.0Level: LLTClassification code 10019751Term: Hepatitis C virusSystem Organ Class: 100000004848; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2014-000343-32-DE
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-04-02
• Study Completion: 2018-12-04
• Last Update Posted: 30 March 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 301

Inclusion Criteria

•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 270
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

•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
Main Objective: •To evaluate the efficacy of MK-5172 in combination with MK-8742 as assessed by the proportion of subjects in the immediate treatment arm 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 in the immediate treatment arm 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. <br><br>;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