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

Phase 2CompletedNCT00120835

Merck Sharp & Dohme LLC

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Chronic Hepatitis C

Interventions

valopicitabineDRUG

pegylated interferonDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (3)

Unnamed facility

Bradenton, Florida, United States

Unnamed facility

San Antonio, Texas, United States

Unnamed facility

Santurce, Puerto Rico

Data from ClinicalTrials.gov

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