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

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.

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Key information

Conditions

Chronic Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Birmingham, Alabama, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

Patient is pregnant or breastfeeding
Patient is co-infected with hepatitis B or HIV

Other protocol-defined exclusion criteria may apply.

Treatment and study plan

valopicitabine

Drug

Pegylated interferon

Drug

Ribavirin

Drug

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Randomized, Phase IIb Clinical Trial to Evaluate the Safety and Antiviral Activity of NM283 and the Combination of Pegylated Interferon Plus NM283, in Patients With Chronic Hepatitis C Who Have Previously Failed to Respond to Standard Therapy

Important dates

Study start: 2005
First posted: Jul 19, 2005
Registry last updated: Jun 10, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed