Valopicitabine When Administered Alone and in Combination With Interferon to Treatment-Naive Patients With Hepatitis C
Phase 1
Completed
- Conditions
- Chronic Hepatitis C
- Registration Number
- NCT00120835
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
This study is being conducted in treatment-naive patients (no previous hepatitis C treatment) to evaluate the safety of valopicitabine (NM283) alone and together with pegylated interferon, a drug approved by the Food and Drug Administration for the treatment of hepatitis C infection. This study is also evaluating the ability of valopicitabine to decrease the amount of hepatitis C virus in the body. The results for patients taking valopicitabine alone will be compared with the results for patients taking valopicitabine together with pegylated interferon.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Documented clinical history compatible with genotype-1, chronic hepatitis C infection
- Treatment-naive (patient has received no previous therapy for hepatitis C viral infection)
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Patient is pregnant
- 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