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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2

Details

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

Criteria

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.