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

Phase 3

Completed

• Conditions: Cirrhosis; Chronic Hepatitis C
• Interventions: Biological: peginterferon alfa-2b (SCH 54031)

• Registration Number: NCT00048724
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-06
• Study First Submitted: 2002-11-06
• Study First Submitted QC: 2002-11-07
• Study First Posted: 2002-11-08
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Results First Submitted: 2009-04-23
• Results First Submitted QC: 2009-04-23
• Results First Posted: 2009-06-11
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-07
• Last Update Posted: 2017-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 631

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PegIntron	peginterferon alfa-2b (SCH 54031)	PegIntron (peginterferon alfa-2b) 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up

Primary Outcome Measures

Name	Time	Method
Time to Observation of the First Clinical Event Experienced by a Subject	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 Outcome Measures

Name	Time	Method
Time to Observation of the Disease Progression Experienced by a Subject	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.