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Trial record 4 of 329 for:    IFNA2 AND RBV AND Hepatitis

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01010646
Recruitment Status : Unknown
Verified September 2013 by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS).
Recruitment status was:  Active, not recruiting
First Posted : November 10, 2009
Last Update Posted : September 20, 2013
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)

Tracking Information
First Submitted Date  ICMJE November 9, 2009
First Posted Date  ICMJE November 10, 2009
Last Update Posted Date September 20, 2013
Study Start Date  ICMJE March 2010
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 9, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01010646 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2009)
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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.
Brief 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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Hepatitis C
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 9, 2009)
84
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2013
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01010646
Other Study ID Numbers  ICMJE 2009-015121-37
ANRS HC 23 COAT-IFN
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Study Sponsor  ICMJE French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Collaborators  ICMJE Flamel Technologies
Investigators  ICMJE
Principal Investigator: Christian TREPO, MD Hôpital de la Croix Rousse, Service d'Hépato-Gastro-Entérologie, 69004 Lyon - FRANCE
PRS Account French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Verification Date September 2013

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