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
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.
2 other identifiers
interventional
84
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Mar 2010
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2009
CompletedFirst Posted
Study publicly available on registry
November 10, 2009
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedJune 5, 2026
September 1, 2013
2.5 years
November 9, 2009
June 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Week 4 and Week 12
Secondary Outcomes (2)
Percentage of patients with early virologic response (EVR) (reduction of at least 2 log viral load) at the end of week 12
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
Week 4 and Week 12
Study Arms (3)
GP1N IFN alfa-2bXL 27 MUI + Ribavirin
EXPERIMENTALIFN alfa-2bXL 27 MUI, powder and solvent for solution injection
GP2N IFN alfa-2b XL 36 MUI + Ribavirin
EXPERIMENTALIFN alfa-2b XL 36 MUI, powder and solvent for solution injection
GP3N IFN peg alfa-2b 1.5 µg/kg + Ribavirin
ACTIVE COMPARATORIFN peg alfa-2b 1.5 µg/kg,administered once a week for 12 weeks by subcutaneous injections
Interventions
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 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 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
You may qualify if:
- 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
You may not qualify if:
- History of solid organ transplantation
- Severe systemic infection, uncontrolled diabetes, cancers, associated liver disease
- General anesthesia or recent blood transfusion
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ANRS, Emerging Infectious Diseaseslead
- Flamel Technologiescollaborator
Study Sites (1)
Hôpital de la Croix Rousse
Lyon, 69004, France
Related Publications (1)
Trepo, Christian1,2; Maynard-Muet, Marianne1,2; Pradat, Pierre1,2; Larrey, Dominique G.3; Marcellin, Patrick4; Pol, Stanislas5; de Ledinghen, Victor6; Causse, Xavier7; Ribard, Didier8; Serfaty, Lawrence9; Bourliere, Marc10; Berthillon, Pascale2; Guest, Maryline11; Kravtzoff, Roger11. Interim report on efficacy results of a new sustained release interferon-alpha-2b (IFNα-2bXL) compared with Pegylated IFN-alpha-2b during a 3-month course of combined therapy with ribavirin in hepatitis C patients (Phase 2 study: ANRS HC23 COAT-IFN): 1761. Hepatology 56():p 1013A, October 2012.
BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christian TREPO, MD
Hôpital de la Croix Rousse, Service d'Hépato-Gastro-Entérologie, 69004 Lyon - FRANCE
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2009
First Posted
November 10, 2009
Study Start
March 1, 2010
Primary Completion
September 1, 2012
Study Completion
June 1, 2013
Last Updated
June 5, 2026
Record last verified: 2013-09