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:
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
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: August 20, 2012
Last verified: August 2012
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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:
Drug Information available for:
Ribavirin
Interferon Alfa-2a
Interferon Alfa-2b
Hepatitis A Vaccines
U.S. FDA Resources
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: | June 2013 |
| Estimated 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: | August 20, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
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 May 19, 2013