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

Completed · Phase 2

Conditions studied: Chronic Hepatitis C

In brief

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.

Key facts

Study ID

NCT00120861

Run by

Merck Sharp & Dohme LLC

Starts

2005-01-01

Last updated by the study team

2010-06-10

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

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

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Los Angeles, California, United States
• Study site — San Francisco, California, United States
• Study site — Miami, Florida, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Detroit, Michigan, United States
• Study site — New York, New York, United States
• Study site — Dallas, Texas, United States
• Study site — Houston, Texas, United States
• Study site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.