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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

631 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2008-04-30

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.

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Detailed Description

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Conditions

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Chronic Hepatitis C Cirrhosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PegIntron

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

Group Type EXPERIMENTAL

peginterferon alfa-2b (SCH 54031)

Intervention Type BIOLOGICAL

0.5 µg/kg subcutaneously once weekly for 60 months

Untreated Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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peginterferon alfa-2b (SCH 54031)

0.5 µg/kg subcutaneously once weekly for 60 months

Intervention Type BIOLOGICAL

Other Intervention Names

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PegIntron

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No