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

November 9, 2009
September 19, 2013
March 2010
September 2012   (final data collection date for primary outcome 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01010646 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
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.

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Hepatitis C
  • 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
  • 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
  • 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
  • Experimental: GP1N IFN alfa-2bXL 27 MUI + Ribavirin
    IFN alfa-2bXL 27 MUI, powder and solvent for solution injection
    Intervention: Drug: IFN alfa-2b XL 27 MUI + Ribavirin
  • Experimental: GP2N IFN alfa-2b XL 36 MUI + Ribavirin
    IFN alfa-2b XL 36 MUI, powder and solvent for solution injection
    Intervention: Drug: IFN alfa-2b XL 36 MUI + Ribavirin
  • 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
    Intervention: Drug: IFN peg alfa-2b 1.5 µg/kg + Ribavirin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
84
November 2013
September 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01010646
2009-015121-37, ANRS HC 23 COAT-IFN
Yes
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Flamel Technologies
Principal Investigator: Christian TREPO, MD Hôpital de la Croix Rousse, Service d'Hépato-Gastro-Entérologie, 69004 Lyon - FRANCE
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP