Back to resultsStudy 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)
Primary Purpose
Chronic Hepatitis C
Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
IFN alfa-2b XL 27 MUI + Ribavirin
IFN alfa-2b XL 36 MUI + Ribavirin
IFN peg alfa-2b 1.5 µg/kg + Ribavirin
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis C focused on measuring hepatitis C, viral kinetics, antiviral response, Genotype 1 or 4
Eligibility 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
Sites / Locations
- Hôpital de la Croix Rousse
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
GP1N IFN alfa-2bXL 27 MUI + Ribavirin
GP2N IFN alfa-2b XL 36 MUI + Ribavirin
GP3N IFN peg alfa-2b 1.5 µg/kg + Ribavirin
Arm Description
IFN alfa-2bXL 27 MUI, powder and solvent for solution injection
IFN alfa-2b XL 36 MUI, powder and solvent for solution injection
IFN peg alfa-2b 1.5 µg/kg,administered once a week for 12 weeks by subcutaneous injections
Outcomes
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
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
Percentage of patients with complete early virologic response (EVR) (viral load <15 IU) at the end of the week 12
Full Information
NCT ID
NCT01010646
First Posted
November 9, 2009
Last Updated
September 19, 2013
Sponsor
ANRS, Emerging Infectious Diseases
Collaborators
Flamel Technologies
1. Study Identification
Unique Protocol Identification Number
NCT01010646
Brief Title
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
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
March 2010 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
November 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ANRS, Emerging Infectious Diseases
Collaborators
Flamel Technologies
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
Keywords
hepatitis C, viral kinetics, antiviral response, Genotype 1 or 4
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
GP1N IFN alfa-2bXL 27 MUI + Ribavirin
Arm Type
Experimental
Arm Description
IFN alfa-2bXL 27 MUI, powder and solvent for solution injection
Arm Title
GP2N IFN alfa-2b XL 36 MUI + Ribavirin
Arm Type
Experimental
Arm Description
IFN alfa-2b XL 36 MUI, powder and solvent for solution injection
Arm Title
GP3N IFN peg alfa-2b 1.5 µg/kg + Ribavirin
Arm Type
Active Comparator
Arm Description
IFN peg alfa-2b 1.5 µg/kg,administered once a week for 12 weeks by subcutaneous injections
Intervention Type
Drug
Intervention Name(s)
IFN alfa-2b XL 27 MUI + Ribavirin
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
IFN alfa-2b XL 36 MUI + Ribavirin
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
IFN peg alfa-2b 1.5 µg/kg + Ribavirin
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian TREPO, MD
Organizational Affiliation
Hôpital de la Croix Rousse, Service d'Hépato-Gastro-Entérologie, 69004 Lyon - FRANCE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital de la Croix Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France
12. IPD Sharing Statement
Links:
URL
http://www.anrs.fr
Description
French National Agency for Research on AIDS and Viral Hepatitis website
Learn more about this trial
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
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