Peg-Intron for Prevention of Disease Progress in Chronic Hepatitis C Patients With Cirrhosis (Study P02569)

The objective of the study is to evaluate the safety and efficacy of PEG-Intron vs. no treatment for the prevention of disease progression in adult subjects with compensated cirrhosis secondary to chronic hepatitis C, who failed to respond to therapy with an a interferon plus ribavirin.

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Key information

Conditions

Chronic Hepatitis C Blood-Borne Infections Chronic Disease Cirrhosis Communicable Diseases Digestive System Diseases Disease Attributes Fibrosis 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 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Age at entry 18-65 years;
Non-responders to previous treatment (minimum of 3 months) with an alpha interferon plus ribavirin;
Liver biopsy demonstrating cirrhosis

Exclusion criteria

Any other cause for liver disease other than chronic hepatitis C;
History or presence of complications of cirrhosis;
Alcohol or illicit drug abuse or treatment with methadone within the past 2 years;
Diseases or conditions that could interfere with participation in the study

Treatment and study plan

peginterferon alfa-2b (SCH 54031)

Biological

0.5 µg/kg subcutaneously once weekly for 60 months

Other names: PegIntron

Primary outcomes

Time to Observation of the First Clinical Event Experienced by a Subject

Time frame: Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event

Clinical events are liver decompensation [variceal bleeding, development of Child-Pugh Class C, hepatic encephalopathy ≥Grade 2, ascites], hepatic carcinoma, death, and/or liver transplantation

Secondary outcomes

Time to Observation of the Disease Progression Experienced by a Subject

Time frame: Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event

Disease progression was observation of any clinical event defined for the primary outcome, plus any of development of Child-Pugh Class B, emergence of varices, or enlargement of pre-existing varices requiring additional therapy.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

PEG-Intron as Maintenance Therapy vs. an Untreated Control Group in Adult Subjects With Compensated Cirrhosis (METAVIR F4), Secondary to Chronic Hepatitis C, Who Have Failed to Respond to Therapy With Any Alpha Interferon Plus Ribavirin

Important dates

Study start: 2002
Primary completion: 2008
Study completion: 2008
First posted: Nov 8, 2002
Registry last updated: Apr 4, 2017

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