EUCTR2014-000137-22-DE
Active, not recruiting
Phase 1
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, GT5, and GT6 Infection - MK-5172 in Combination with MK-8742 in Treatment-Naïve Subjects
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.0 sites400 target enrollmentApril 3, 2014
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Hepatitis C
- Sponsor
- Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
- Enrollment
- 400
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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