NCT01447420

A Study of Sustained Virological Response in Relation to IL28-b Expression in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1 on Combination Treatment With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)

A Clinical Trial Comparing the Sustained Virological Response in Terms of Expression Profile of IL- 28B in Genotype 1 HCV-Infected Treatment-Naïve Subjects With Chronic Hepatitis C on Pegasys® (Peginterferon Alfa-2A) Plus Copegus® (Ribavirin)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

This multi-center, open-label study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) in relation to IL28-b gene expression in treatment-naïve patients with chronic hepatitis C genotype 1. Patients will receive Pegasys (180 mcg sc weekly) and Copegus ( 1'000 or 1'200 mg orally daily) for 48 weeks. Anticipated time of study treatment is 48 weeks, follow-up is 24 weeks.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	peginterferon alfa-2a	180 mcg sc weekly, 48 weeks
DRUG	ribavirin [Copegus]	1'000 or 1'200 mg orally daily, 48 weeks

Timeline

• Start date: 2011-02-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2011-10-06
• Last updated: 2016-07-25
• Results posted: 2016-06-24

Locations

15 sites across 1 country: Brazil