MK-5172/MK-8742 vs Sofosbuvir/PR in HCV GT1, 4 or 6 Infectio

Phase 1

• Conditions: Hepatitis C; MedDRA version: 17.1 Level: LLT Classification code 10019751 Term: Hepatitis C virus System Organ Class: 100000004848; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2014-003836-38-NO
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-17
• Study Completion: 2016-02-16
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 257

Inclusion Criteria

•You are greater than or equal to 18 years of age
•You have chronic HCV GT1
•You have had a liver biopsy, Fibroscan or Fibrotest to check for cirrhosis or no cirrhosis
•Have documented chronic HCV GT 1, 4 or 6 (with no evidence of non-typeable or mixed genotype) infection:
-Positive for anti-HCV antibody, HCV RNA, or HCV GT 1, 4 or 6 at least 6 months before screening (HCV RNA and HCV genotype must be confirmed by screening lab results), or
-Positive for anti-HCV antibody or HCV RNA at the time of screening with a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed before enrollment with evidence of CHC disease, such as the presence of fibrosis)

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 226
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

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 pre-existing psychiatric condition
•You have an exclusionary laboratory value
•You intend to become pregnant or plan to impregnate during the study

Study & Design

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