Valopicitabine When Administered Alone and in Combination With Interferon to Treatment-Naive Patients With Hepatitis C

Completed · Phase 1/Phase 2

Conditions studied: Chronic Hepatitis C

In brief

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.

Key facts

Study ID

NCT00120835

Run by

Merck Sharp & Dohme LLC

Starts

2004-07-01

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 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.

You may not qualify if…

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

Where it is running

• Study site — Bradenton, Florida, United States
• Study site — San Antonio, Texas, United States
• Study site — Santurce, Puerto Rico

Full record on ClinicalTrials.gov

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