Trial | NCT01010646  Report issue

Title

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.

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    ribavirin interferon alpha-2b ...

  • Study Participants

    84
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.
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 Started
Mar 31
2010
Primary Completion
Sep 30
2012
Study Completion
Nov 30
2013
Anticipated
Last Update
Sep 20
2013
Estimate

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

GP1N IFN alfa-2bXL 27 MUI + Ribavirin Experimental

IFN alfa-2bXL 27 MUI, powder and solvent for solution injection

GP2N IFN alfa-2b XL 36 MUI + Ribavirin Experimental

IFN alfa-2b XL 36 MUI, powder and solvent for solution injection

GP3N IFN peg alfa-2b 1.5 µg/kg + Ribavirin Active Comparator

IFN peg alfa-2b 1.5 µg/kg,administered once a week for 12 weeks by subcutaneous injections

Criteria 

Inclusion Criteria:

Patient having voluntarily signed the Informed Consent Form prior to any study specific procedure being performed
Male or female HCV genotype 1 or 4 infected patients (positive serum HCV RNA), aged between 18 and 65 years inclusive, with a body mass within the range over or equal of 45Kg and below or equal to 100 Kg
Patient being either naïve to therapy, either non-responder to previous standard Peg-interferon α + ribavirin therapy,
With no absolute contra-indication to interferon α or ribavirin
Female patients must be non-lactating and of non-childbearing potential, or have a negative pregnancy test results to enter the study
No evidence of acute or advanced liver disease, uncontrolled diabetes, cardiovascular, immunological, or thyroid disease, and no recently diagnosed malignancy
Vital signs within normal ranges, or if outside the normal ranges, not deemed clinically significant in the opinion of the Investigator. An ECG with no clinically significant abnormalities

Exclusion Criteria:

History of solid organ transplantation
Severe systemic infection, uncontrolled diabetes, cancers, associated liver disease
General anesthesia or recent blood transfusion
No Results Posted