NCT00759109

Pegylated Alfa-2b Interferon Therapy of Patients With Hepatitis C-related Cirrhosis and High Liver Cell Proliferation (P02733/MK-4031-085)

Long-term Pegylated Alfa-2b Interferon Therapy of Patients With Hepatitis C-related Cirrhosis and High Liver Cell Proliferation: a Multicenter Study of Hepatocellular Carcinoma Prevention in Patients Non-responders to Combined Therapy With Alpha Interferon + Ribavirin or Peginterferon Alpha + Ribavirin or to Interferon Monotherapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study aims to compare the role of peginterferon α-2b (50 μg/week) vs. control (no treatment) in the prevention of hepatocellular carcinoma, in adult patients with cirrhosis and initial signs of portal hypertension who did not respond to previous combined therapy with interferon alfa + ribavirin or peginterferon alfa + ribavirin or to interferon alfa monotherapy and with a high proliferation rate before entering the study. The duration of treatment will be 3 years, and the follow-up period will be 2 years.

Conditions

• Carcinoma, Hepatocellular

Interventions

Type	Name	Description
BIOLOGICAL	Peginterferon alfa-2b	Peginterferon alfa-2b, 50 μg, weekly, SC, for a period of 3 years.
OTHER	Observation (no treatment)	No treatment was given to participants enrolled in the control arm (Arm B).

Timeline

• Start date: 2002-03-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2008-09-25
• Last updated: 2017-04-07
• Results posted: 2011-04-18