An Open-Label, Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and the Antiviral Activity of NM283 When Administered Alone and in Combination With Pegylated Interferon Alfa 2b to Treatment-Naive Adults With Genotype-1 Chronic Hepatitis C

Merck Sharp & Dohme LLC3 sites in 2 countriesStarted: July 2004Last updated: June 10, 2010

Conditions

Drugs

Trial Snapshot

Phase: Phase 1
Status: Completed
Sponsor: Merck Sharp & Dohme LLC
Locations: 3

Study Overview Study Design Eligibility Criteria Investigators Sites Records & Identifiers Similar Trials

Study Overview

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.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Treatment
Masking: None

Eligibility Criteria

Ages: 18 Years to 65 Years (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

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.

Investigators

Sponsor

Merck Sharp & Dohme LLC

Sponsor Class

Industry

Study Sites (3)

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