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

• Conditions: Chronic hepatitis C infection; MedDRA version: 9.1Level: LLTClassification code 10019751Term: Hepatitis C virus

• Registration Number: EUCTR2008-000150-12-AT
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-02
• Last Update Posted: 9 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

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.

Study & Design

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