Valopicitabine Alone and Together With Pegylated Interferon in Patients With Chronic Hepatitis C Who Have Failed to Respond to Standard Therapy

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Chronic Hepatitis C

Treatments: Drug: ribavirin; Drug: valopicitabine; Drug: pegylated interferon

Study type: Interventional

Funder types: Industry

Identifiers

NCT00120861

NV-08A-004

Details and patient eligibility

About

This study is being conducted to compare the safety, effectiveness and tolerance of valopicitabine (NM283) when used alone and when valopicitabine is used together with pegylated interferon in hepatitis C treatment failure patients. These results will be compared against the results of treatment with pegylated interferon plus ribavirin, the current standard therapy for treatment of hepatitis C viral infection.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Documented clinical history compatible with chronic hepatitis C and compensated liver disease
• Failed response to previous hepatitis C therapy of pegylated interferon/ribavirin

Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Patient is pregnant or breastfeeding
• Patient is co-infected with hepatitis B or HIV

Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)