EUCTR2014-003836-38-NO
Active, not recruiting
Phase 1
A Phase III, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 versus Sofosbuvir/Pegylated Interferon/Ribavirin (PR) in Treatment-Naïve and PR Prior Treatment Failure Subjects with Chronic HCV GT1, 4 or 6 Infection - MK-5172/MK-8742 vs Sofosbuvir/PR in HCV GT1, 4 or 6 Infection
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.0 sites257 target enrollmentDecember 17, 2014
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Hepatitis C
- Sponsor
- Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
- Enrollment
- 257
- Status
- Active, not recruiting
- Last Updated
- 7 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
- •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
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
Outcomes
Primary Outcomes
Not specified
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