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Study Comparing Reduction and Viral Safety of IFN Alfa-2b XL + Ribavirin Versus PEG IFN Alfa-2b + Ribavirin in Patients With Chronic Hepatitis C Genotype 1

2014-08-27 03:18:04 | BioPortfolio

Summary

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.

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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Chronic Hepatitis C

Intervention

IFN alfa-2b XL 27 MUI + Ribavirin, IFN alfa-2b XL 36 MUI + Ribavirin, IFN peg alfa-2b 1.5 µg/kg + Ribavirin

Location

Hôpital Hotel Dieu
Lyon
France
69288

Status

Recruiting

Source

French National Agency for Research on AIDS and Viral Hepatitis

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:04-0400

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Medical and Biotech [MESH] Definitions

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A nucleoside antimetabolite antiviral agent that blocks nucleic acid synthesis and is used against both RNA and DNA viruses.

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