Overview

This trial is active, not recruiting.

Condition chronic hepatitis c
Treatments ifn alfa-2b xl 27 mui + ribavirin, ifn alfa-2b xl 36 mui + ribavirin, ifn peg alfa-2b 1.5 µg/kg + ribavirin
Phase phase 2
Sponsor French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Collaborator Flamel Technologies
Start date March 2010
End date September 2012
Trial size 84 participants
Trial identifier NCT01010646, 2009-015121-37, ANRS HC 23 COAT-IFN

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
IFN alfa-2bXL 27 MUI, powder and solvent for solution injection
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
(Experimental)
IFN alfa-2b XL 36 MUI, powder and solvent for solution injection
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
(Active Comparator)
IFN peg alfa-2b 1.5 µg/kg,administered once a week for 12 weeks by subcutaneous injections
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

Primary Outcomes

Measure
Viral load decrease at Week 4 and Week 12 of treatment with IFN alfa-2b XL 27 MIU, IFN alfa-2b XL 36 MIU and the marketed reference product (PEG IFN alfa-2b 1.5μg/kg) in combination with ribavirin
time frame: Week 4 and Week 12

Secondary Outcomes

Measure
Percentage of patients with early virologic response (EVR) (reduction of at least 2 log viral load) at the end of week 12
time frame: Week 4 and Week 12
Percentage of patients with complete early virologic response (EVR) (viral load <15 IU) at the end of the week 12
time frame: Week 4 and Week 12

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

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.
Principal investigator Christian TREPO, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS).