A Phase II Randomized, Placebo-Controlled Study to Evaluate the Safety andTolerability of MK-7009 When Administered Concomitantly With Pegylated Interferonand Ribavirin in Patients With Chronic Hepatitis C Infection
- Conditions
- Chronic hepatitis C infectionMedDRA version: 9.1Level: LLTClassification code 10019751Term: Hepatitis C virus
- Registration Number
- EUCTR2008-000150-12-GB
- Lead Sponsor
- Merck Sharp & Dohme Corp.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 160
Patients (men and women 18 to 65 years of age) with chronic compensated genotype 1 HCV infection as defined by 1) positive serology for HCV with HCV RNA levels =4 ×105 IU/mL in peripheral blood at screening (within 60 days prior to the first dose of MK-7009); 2) evidence of chronic HCV infection as assessed by positive serology for HCV or detectable HCV RNA =6 months prior to the first dose of MK-7009; and 3) absence (no medical history or physical findings) of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease.
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Patient has non-genotype 1 HCV infection, including mixed genotype and has evidence or history of chronic hepatitis not caused by HCV, including but not limited to non-alcoholic steatohepatitis (NASH), drug-induced hepatitis, and autoimmune hepatitis.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method