Study Comparing Reduction and Viral Safety of IFN Alfa-2b XL + Ribavirin Versus PEG IFN Alfa-2b + Ribavirin in Patients With Chronic Hepatitis C Genotype 1 - Full Text View

Sponsor:	French National Agency for Research on AIDS and Viral Hepatitis
Information provided by (Responsible Party):	French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:	NCT01010646

Purpose

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.

Condition	Intervention	Phase
Chronic Hepatitis C	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	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	ANRS HC 23 COAT-IFN

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Ribavirin Interferon alfa-2a Interferon alfa-2b

U.S. FDA Resources

Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	84
Study Start Date:	March 2010
Estimated Study Completion Date:	March 2012
Estimated Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: GP1N IFN alfa-2bXL 27 MUI + Ribavirin IFN alfa-2bXL 27 MUI, powder and solvent for solution injection	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
Experimental: GP2N IFN alfa-2b XL 36 MUI + Ribavirin IFN alfa-2b XL 36 MUI, powder and solvent for solution injection	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
Active Comparator: GP3N 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	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

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01010646

Contacts

Contact: Laurence ALLAIN	33 1 53 94 60 47	laurence.allain@anrs.fr
Contact: Karim KAABECHE	33 1 53 94 60 43	karim.kaabeche@anrs.fr

Locations

France
Hôpital Hotel Dieu	Recruiting
Lyon, France, 69288
Contact: Christian TREPO, MD 33 4 72 41 30 88 christian.trepo@chu-lyon.fr
Contact: Marianne MAYNARD, MD 33 4 72 41 30 88 marianne.maynard-muet@chu-lyon.fr

Sponsors and Collaborators

French National Agency for Research on AIDS and Viral Hepatitis

Investigators

Principal Investigator:

Christian TREPO, MD

Hôpital Hotel Dieu, Service d'Hépatologie et de Gastro-Entérologie, 69288 Lyon CEDEX 02 - FRANCE

More Information

Additional Information:

French National Agency for Research on AIDS and Viral Hepatitis website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:	NCT01010646 History of Changes
Other Study ID Numbers:	2009-015121-37, ANRS HC 23 COAT-IFN
Study First Received:	November 9, 2009
Last Updated:	December 21, 2011
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:

hepatitis C
viral kinetics
antiviral response
Genotype 1

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferon Alfa-2a
Interferon-alpha

Interferon Alfa-2b
Ribavirin
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Immunologic Factors
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012