NCT00304551

A Study of Peginterferon Alfa-2a in Combination With Ribavirin in Chronic Hepatitis C (CHC) Patients With Compensated Liver Cirrhosis (LC)

A Phase II/III Study of Peginterferon Alfa-2a in Combination With Ribavirin for the Treatment of CHC With Compensated LC

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Chugai Pharmaceutical · Industry
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study evaluated the clinical response of the efficacy and safety of the combination therapy of peginterferon alfa-2a and ribavirin, compared with an antiviral treatment-free group in CHC patients with compensated LC. Additionally, this study evaluated the dosage reactivity and the pharmacokinetic characteristics of the combination therapy of peginterferon alfa-2a and ribavirin in CHC patients with compensated LC.

Conditions

• Liver Cirrhosis
• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	peginterferon alfa-2a 180μg	180μg（s.c.）/week for 48 weeks
DRUG	peginterferon alfa-2a 90μg	90μg(s.c.)/week for 48 weeks
DRUG	ribavirin	600, 800, or 1,000 mg X 2(p.o.)/day

Timeline

• Start date: 2006-06-01
• Primary completion: 2009-12-01
• Completion: 2010-06-01
• First posted: 2006-03-20
• Last updated: 2010-06-03

Locations

8 sites across 1 country: Japan