Valopicitabine Alone and Together With Pegylated Interferon in Patients With Chronic Hepatitis C Who Have Failed to Respond to Standard Therapy
Phase 2
Completed
- Conditions
- Chronic Hepatitis C
- Registration Number
- NCT00120861
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method