A Study to Evaluate the Combination of Pegylated Interferon Alfa Plus Valopicitabine in Patients With Hepatitis C

Phase 2

Completed

• Conditions: Chronic Hepatitis C

• Registration Number: NCT00118768
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

This Phase II study is being conducted in treatment-naive patients (no previous antiviral therapy for Hepatitis C infection) with genotype-1 chronic hepatitis C to evaluate the safety and effectiveness of valopicitabine alone and together with Pegylated Interferon (a drug approved by the Food and Drug Administration for the treatment of Hepatitis C infection).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-06-30
• Study First Submitted QC: 2005-07-08
• Study First Posted: 2005-07-12
• Study Start: 2005-08
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-27
• Last Update Posted: 2009-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

• Documented clinical history of genotype-1 chronic Hepatitis C and compensated liver disease
• Treatment Naive (patient has received no previous treatment for chronic hepatitis C infection)
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

• Patient is pregnant or breastfeeding
• Patient is co-infected with HIV or Hepatitis B
• Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL