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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Chronic Hepatitis C

Treatments: Drug: Pegylated Interferon Alfa; Drug: valopicitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00118768

NV-08A-006

Details and patient eligibility

About

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).

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)