A Study to Evaluate the Combination of Pegylated Interferon Alfa Plus Valopicitabine in Patients With Hepatitis C

Completed · Phase 2

Conditions studied: Chronic Hepatitis C

In brief

This Phase II study is being conducted in treatment-naive patients (no previous antiviral therapy for Hepatitis C infection) with genotype-1 chronic hepatitis C to evaluate the safety and effectiveness of valopicitabine alone and together with Pegylated Interferon (a drug approved by the Food and Drug Administration for the treatment of Hepatitis C infection).

Key facts

Study ID

NCT00118768

Run by

Merck Sharp & Dohme LLC

People needed

175

Starts

2005-08-01

Last updated by the study team

2009-03-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Documented clinical history of genotype-1 chronic Hepatitis C and compensated liver disease
• Treatment Naive (patient has received no previous treatment for chronic hepatitis C infection)
• Other protocol-defined inclusion criteria may apply.

You may not qualify if…

• Patient is pregnant or breastfeeding
• Patient is co-infected with HIV or Hepatitis B
• Other protocol-defined exclusion criteria may apply.

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — San Diego, California, United States
• Study site — San Mateo, California, United States
• Study site — Lakewood, Colorado, United States
• Study site — Bradenton, Florida, United States
• Study site — Gainesville, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Laurel, Maryland, United States
• Study site — Worcester, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — Kansas City, Missouri, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — New York, New York, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Germantown, Tennessee, United States
• Study site — San Antonio, Texas, United States
• Study site — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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