MK-5172 in Combination with MK-8742

Phase 1

Active, not recruiting

• Conditions: Hepatitis C; Therapeutic area: Diseases [C] - Virus Diseases [C02]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05-30
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: Not specified
• Target Recruitment: 200

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 200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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