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COMPLETED
NCT01010646
PHASE2

Study Comparing the Tolerability and Viral Reduction of the Combination of IFN a-2b XL + Ribavirin Versus Peg IFN a-2b + Ribavirin in Patients With Chronic Hepatitis C, Genotype 1 or 4

Sponsor: ANRS, Emerging Infectious Diseases

View on ClinicalTrials.gov

Summary

Three-parallel-arm, open-label, international (France and Romania) study, comparing three treatments The purpose of this study is to confirm if IFN alfa-2b XL has a better antiviral activity and tolerability as compared with current marketed reference, while combined with ribavirin, in a 3-month therapy setting.

Official title: Multicentre, Randomised, Open-label Study Comparing the Tolerability and Viral Reduction of the Combination of IFN Alpha-2b XL + Ribavirin Versus Peg IFN Alpha-2b + Ribavirin in Patients With Chronic Hepatitis C, Genotype 1 or 4.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

84

Start Date

2010-03

Completion Date

2013-06

Last Updated

2026-06-05

Healthy Volunteers

No

Interventions

DRUG

IFN alfa-2b XL 27 MUI + Ribavirin

IFN alfa-2b XL 27 MUI administered once a week for 12 weeks by subcutaneous injections, in combination with weight dosed ribavirin daily administered orally in two divided doses

DRUG

IFN alfa-2b XL 36 MUI + Ribavirin

IFN alfa-2b XL 36 MUI administered once a week for 12 weeks by subcutaneous injections in combination with weight dosed ribavirin daily administered orally in two divided doses

DRUG

IFN peg alfa-2b 1.5 µg/kg + Ribavirin

IFN peg alfa-2b 1.5 µg/kg administered once a week for 12 weeks by subcutaneous injections in combination with weight dosed ribavirin daily administered orally in two divided doses

Locations (1)

Hôpital de la Croix Rousse

Lyon, France