EUCTR2008-000150-12-ATActive, not recruitingNot Applicable
A Phase II Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of 4 Different Regimens of MK-7009 When Administered Concomitantly with Pegylated Interferon and Ribavirin in Treatment-Experienced Patients with Chronic Genotype 1 Hepatitis C Virus Infection
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.0 sites300 target enrollmentStarted: March 2, 2009Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 300
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Patients (men and women 18 to 65 years of age) have chronic, compensated, genotype 1 HCV infection as defined by:
- •Positive serology for HCV with HCV RNA levels =4 ×105 IU/mL in peripheral blood at screening (within 75 days prior to first dose of MK-7009).
- •Evidence of chronic HCV infection for =6 months prior to first dose of MK-7009 as assessed by positive serology for HCV or detectable HCV RNA.
- •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
Exclusion Criteria
- •Patient has non-genotype 1 HCV infection, including mixed genotype. Patient has evidence or history of chronic hepatitis not caused by HCV, including but not limited to nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, and autoimmune hepatitis.
Investigators
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