NCT01010646

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

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.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: ANRS, Emerging Infectious Diseases · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Interferon alfa-2b XL (IFN alfa-2b XL) is a novel sustained release interferon α-2b drug product that is being developed by FLAMEL TECHNOLOGIES using its Medusa® technology, aiming at reducing the toxicity and enhancing the biological response. In the present study, patients will be randomly assigned to either IFN alfa-2b XL 27 MUI, IFN alfa-2b XL 36 MUI, or IFN peg alfa-2b 1.5 µg/kg, all administered once a week for 12 weeks by subcutaneous injections, in combination with weight dosed ribavirin daily administered orally in two divided doses. Doses will be adapted according to the dose modification guidelines for combination therapy labelled in the ribavirin prescribing information.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
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

Timeline

• Start date: 2010-03-01
• Primary completion: 2012-09-01
• Completion: 2013-11-01
• First posted: 2009-11-10
• Last updated: 2013-09-20

Locations

1 site across 1 country: France