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

Peg-Intron for Prevention of Disease Progression in Chronic Hepatitis C Patients with Cirrhosis who failed with a Interferon plus Ribavirin Therapy

Conditions

– Chronic Hepatitis C- Cirrhosis

Study Type

Interventional

Study Design

Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study

Further Details

Study Start

January 2003

Eligibility & Criteria

Ages Eligible for Study: 18 Years – 65 Years, Genders Eligible for Study: Both Criteria Inclusion Criteria:Age at entry 18-65 years; non-responders to previous treatment (minimum of 3 months) with an a 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

Total Enrolment

1000

Contact Details

[1] Westmead Hospital, Sydney, Australia [2] Alfred Hosptial, Melbourne, Australia