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

Chronic Hepatitis C Clinical Trial

— COAT IFN  

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01010646
• Other study ID #: 2009-015121-37
• Secondary ID: ANRS HC 23 COAT-
• Status: Active, not recruiting
• Phase: Phase 2
• First received: November 9, 2009
• Last updated: September 19, 2013
• Start date: March 2010
• Est. completion date: November 2013

Study information

• Verified date: September 2013
• Source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 84
• Est. completion date: November 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 a + ribavirin therapy,

• With no absolute contra-indication to interferon a 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

Study Design

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

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
France	Hôpital de la Croix Rousse	Lyon

Sponsors (2)

Lead Sponsor	Collaborator
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)	Flamel Technologies

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Week 4 and Week 12	No
Secondary	Percentage of patients with early virologic response (EVR) (reduction of at least 2 log viral load) at the end of week 12		Week 4 and Week 12	No
Secondary	Percentage of patients with complete early virologic response (EVR) (viral load <15 IU) at the end of the week 12		Week 4 and Week 12	No

External Links

•   French National Agency for Research on AIDS and Viral Hepatitis website