Study to Evaluate Different Regimens of Vaniprevir (MK7009) for the Treatment of Chronic Genotype 1 Hepatitis C Virus Infection in Treatment-naive Patients (MK-7009-019)(WITHDRAWN)

• Status: Withdrawn
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety, tolerability, and efficacy of vaniprevir when administered concomitantly with pegylated interferon (peg-IFN) and ribavirin (RBV) to treat treatment-naive genotype 1 hepatitis C virus (HCV)-infected patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Interferons; Ribavirin

Criteria

Inclusion Criteria:

• Patient has chronic genotype 1 HCV infection

• Patient has had a liver biopsy without evidence of cirrhosis

• Patient has had an eye exam prior to the start of study

• Female patients capable of having children and male patients with female partners capable of having children agree to use two forms of birth control throughout the study

Exclusion Criteria:

• Patient has had previous treatment with: 3 or more doses IFN, peg-IFN, and/or RBV; and stopped treatment due to intolerance of one of the drugs; other antiviral or investigational therapies or vaccines for HCV

• Female patient is pregnant or breastfeeding

• Patient has chronic hepatitis not caused by HCV

• Patient has evidence of cirrhosis of the liver

• Patient has HIV

• Patient has active hepatitis B infection

• Patient has non-genotype 1 HCV infection

• Patient consumes excessive amounts of alcohol