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)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Flamel Technologies
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier:
NCT01010646
First received: November 9, 2009
Last updated: September 19, 2013
Last verified: September 2013
  Purpose

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.


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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

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: November 2013
Primary Completion Date: September 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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01010646

Locations
France
Hôpital de la Croix Rousse
Lyon, France, 69004
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Flamel Technologies
Investigators
Principal Investigator: Christian TREPO, MD Hôpital de la Croix Rousse, Service d'Hépato-Gastro-Entérologie, 69004 Lyon - FRANCE
  More Information

Additional Information:
No publications provided

Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
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: September 19, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM)

Keywords provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):
hepatitis C
viral kinetics
antiviral response
Genotype 1 or 4

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
Reaferon
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
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on April 15, 2014