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Date: 2009-12-18
Phase: IIa
Anouncement: Launch
Biotech: Flamel Technologies (France)
Product: IFN-Alpha-2b XL (interferon alpha-2b XL - controlled release of unmodified interferon alpha-2b)
Disease: chronic hepatitis C
Country: France
Other: Flamel Technologies announced the initiation of a Phase 2a clinical trial of its
Interferon alpha-2b XL (IFN-alpha-2b XL), which is based on its Medusa® platform for controlled release of biologics. This Phase 2a randomized study, known as ANRS HC 23 COAT-IFN (COnfirmation of Anti-viral activity and Tolerance of Interferon alpha-2b XL), is sponsored by the Agence Nationale de Recherche sur le SIDA et les Hépatites Virales (ANRS).
The study is designed to evaluate IFN-alpha-2b XL in combination with ribavirin in genotype-1 chronic hepatitis C patients who are either naïve to treatment or previous non-responders to standard interferon therapy (PEGylated interferon plus ribavirin). It will evaluate two doses of Interferon-alpha-2b XL (27 and 36 MIU) administered once a week for 12 weeks in combination with weight-based ribavirin in treatment-naïve and non-responder hepatitis C patients with genotype-1 HCV.

A total of 84 patients (28 patients by arm which will be equally split into naïve and non-responder patients) is expected to be enrolled in the trial. The study will assess viral response: the primary endpoint will be viral load reduction at week 4 and week 12. Investigators will also be looking at the percentage of patients achieving Rapid Virological Response, or RVR, defined as an undetectable viral load at week 4, and Early Virological Response, or EVR, defined as a viral load reduction greater than 2 log at week 12. Another endpoint that investigators will be assessing closely is the safety and tolerability data for both doses of Interferon-alpha-2b XL versus PegIntron. Results from the study will be used to select the doses of Interferon-alpha 2b XL for the pivotal confirmatory clinical trial.