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

Merck Sharp & Dohme LLC175 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

175

Conditions

Chronic Hepatitis C

Interventions

valopicitabineDRUG

Pegylated Interferon AlfaDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * Patient is pregnant or breastfeeding * Patient is co-infected with HIV or Hepatitis B * Other protocol-defined exclusion criteria may apply.

Locations (19)

Unnamed facility

Phoenix, Arizona, United States

Unnamed facility

San Diego, California, United States

Unnamed facility

San Mateo, California, United States

Data from ClinicalTrials.gov

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