Status:
COMPLETED
Study to Evaluate Drug-drug Interaction Between Valopicitabine and Ribavirin
Lead Sponsor:
Merck Sharp & Dohme LLC
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This study is being conducted to see if the investigational medication, valopicitabine, is safe to use in combination with ribavirin, a drug approved by the FDA for treating hepatitis C infection.
Eligibility Criteria
Inclusion
- Documented clinical history compatible with chronic hepatitis C and compensated liver disease
- Has not previously received anti-viral therapy for hepatitis C infection
- Other protocol-defined inclusion criteria may apply.
Exclusion
- Patient is pregnant or breastfeeding
- Patient is co-infected with hepatitis B virus and/or HIV
- Other protocol-defined exclusion criteria may apply.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT00395421
Start Date
October 1 2006
End Date
August 1 2008
Last Update
June 10 2010
Active Locations (2)
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1
Atlanta, Georgia, United States
2
Fairfax, Virginia, United States