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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 3

Conditions: Cirrhosis; Chronic Hepatitis C

Treatments: Biological: peginterferon alfa-2b (SCH 54031)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00048724

P02569

Details and patient eligibility

About

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.

Enrollment: 631 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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631 participants in 2 patient groups

PegIntron

Experimental group

Description:

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

Treatment:

Biological: peginterferon alfa-2b (SCH 54031)

Untreated Control

No Intervention group