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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chronic Hepatitis C, Cirrhosis

Intervention / Treatment
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* Biological: peginterferon alfa-2b (SCH 54031)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PegIntron<br>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 | Biological: peginterferon alfa-2b (SCH 54031)<br>* 0.5 µg/kg subcutaneously once weekly for 60 months<br>* Other names: PegIntron;|
| No Intervention: Untreated Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Observation of the First Clinical Event Experienced by a Subject | 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 | Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Observation of the Disease Progression Experienced by a Subject | 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. | Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C; Cirrhosis