MK-5172 in Combination with MK-8742 in Treatment-Naïve Subjects

Phase 1

• Conditions: Hepatitis C; MedDRA version: 17.0Level: LLTClassification code 10019751Term: Hepatitis C virusSystem Organ Class: 100000004848; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2014-000137-22-DE
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-03
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

•You are greater than or equal to 18 years of age
•You have chronic HCV GT1, GT4, GT5, GT6
•You have had a liver biopsy, Fibroscan or Fibrotest to check for cirrhosis or no cirrhosis
•You are treatment naïve to all anti-HCV treatment

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 320
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

•You have signs of decompensated liver disease
•You are coninfected with Hepatitis B
•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified