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

Phase 3 Completed 631 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2002-06
Primary completion: 2008-04
Completion: 2008-04

Outcome

Missed primary endpoint

registry p = 0.1439; Hazard Ratio (HR) 1.452 (95% CI 0.880 to 2.396) NCT00048724 ↗

paper There was no significant difference in time to first clinical event PMID 21419770 ↗

Publications

Bruix J, Poynard T, Colombo M, Schiff E, Burak K, Heathcote EJ, Berg T, Poo JL, Mello CB, Guenther R, Niederau C, Terg R, Bedossa P, Boparai N, Griffel LH, Burroughs M, Brass CA, Albrecht JK; EPIC3 Study Group. Maintenance therapy with peginterferon alfa-2b does not prevent hepatocellular carcinoma in cirrhotic patients with chronic hepatitis C. Gastroenterology. 2011 Jun;140(7):1990-9. doi: 10.1053/j.gastro.2011.03.010. Epub 2011 Mar 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Peginterferon alfa-2b	Protein / enzyme biologic	0.5 ug/kg	Subcutaneous