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
NCT ID: NCT01010646
Last Updated: 2013-09-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
84 participants
INTERVENTIONAL
2010-03-31
2013-11-30
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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GP1N IFN alfa-2bXL 27 MUI + Ribavirin
IFN alfa-2bXL 27 MUI, powder and solvent for solution injection
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
GP2N IFN alfa-2b XL 36 MUI + Ribavirin
IFN alfa-2b XL 36 MUI, powder and solvent for solution injection
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
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
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
Interventions
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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
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
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
Eligibility Criteria
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Inclusion Criteria
* 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
* Severe systemic infection, uncontrolled diabetes, cancers, associated liver disease
* General anesthesia or recent blood transfusion
18 Years
65 Years
ALL
No
Sponsors
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Flamel Technologies
UNKNOWN
ANRS, Emerging Infectious Diseases
OTHER_GOV
Responsible Party
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Principal Investigators
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Christian TREPO, MD
Role: PRINCIPAL_INVESTIGATOR
Hôpital de la Croix Rousse, Service d'Hépato-Gastro-Entérologie, 69004 Lyon - FRANCE
Locations
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Hôpital de la Croix Rousse
Lyon, , France
Countries
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Related Links
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French National Agency for Research on AIDS and Viral Hepatitis website
Other Identifiers
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ANRS HC 23 COAT-IFN
Identifier Type: -
Identifier Source: secondary_id
2009-015121-37
Identifier Type: -
Identifier Source: org_study_id