NCT01429792

A Study Evaluating Slow Response/Non-Rapid Response in Patients With Chronic Hepatitis C, Genotype 1, 2, 3 & 4 Treated With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)

A Multi-Center Study Evaluating the Rate of Genotype 1, 2, 3 & 4 Chronic Hepatitis C Patients With Slow Response / Non-rapid Viral Response to Anti-Viral Treatment of Pegasys (Peginterferon Alfa 2a) in Combination With Copegus (Ribavirin)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,013 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This multi-center study will evaluate the viral response in patients with chronic hepatitis C, genotype 1, 2, 3 \& 4 on standard anti-viral treatment with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin). Patients will receive weekly subcutaneous Pegasys plus daily oral Copegus for 24 weeks (genotype 2 \& 3) or 48 weeks (genotype 1 \& 4). Patients identified as slow responders/non-rapid virological responders will be eligible for an additional 24 weeks of treatment.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	peginterferon alfa-2a [Pegasys]	standard treatment, subcutaneously weekly
DRUG	ribavirin [Copegus]	standard treatment, orally daily

Timeline

• Start date: 2008-09-25
• Primary completion: 2013-06-10
• Completion: 2013-06-10
• First posted: 2011-09-07
• Last updated: 2018-10-23
• Results posted: 2018-10-23

Locations

26 sites across 1 country: Israel