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 (COAT IFN)

ANRS, Emerging Infectious Diseases

Status and phase: Unknown; Phase 2

Conditions: Chronic Hepatitis C

Treatments: Drug: IFN alfa-2b XL 27 MUI + Ribavirin; Drug: IFN alfa-2b XL 36 MUI + Ribavirin; Drug: IFN peg alfa-2b 1.5 µg/kg + Ribavirin

Study type: Interventional

Funder types: Other

Identifiers

NCT01010646

2009-015121-37

ANRS HC 23 COAT-IFN

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 3 patient groups

GP1N IFN alfa-2bXL 27 MUI + Ribavirin

Experimental group

Description:

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

Treatment:

Drug: IFN alfa-2b XL 27 MUI + Ribavirin

GP2N IFN alfa-2b XL 36 MUI + Ribavirin

Experimental group

Description:

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

Treatment:

Drug: IFN alfa-2b XL 36 MUI + Ribavirin

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

Active Comparator group

Description:

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

Treatment:

Drug: IFN peg alfa-2b 1.5 µg/kg + Ribavirin