Chronic Hepatitis CPhase 2COAT IFNNCT01010646
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
A Phase 2 study testing IFN alfa-2b XL 27 MUI + Ribavirin, IFN alfa-2b XL 36 MUI + Ribavirin and IFN peg alfa-2b 1.5 µg/kg + Ribavirin in people with Chronic Hepatitis C, run by ANRS, Emerging Infectious Diseases at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- IFN alfa-2b XL 27 MUI + Ribavirin, IFN alfa-2b XL 36 MUI + Ribavirin and IFN peg alfa-2b 1.5 µg/kg + Ribavirin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2010to Jun 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History of solid organ transplantation
- Severe systemic infection, uncontrolled diabetes, cancers, associated liver disease
- General anesthesia or recent blood transfusion
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Chronic Hepatitis C
- Being tested
- IFN alfa-2b XL 27 MUI + Ribavirin, IFN alfa-2b XL 36 MUI + Ribavirin, IFN peg alfa-2b 1.5 µg/kg + Ribavirin
- Keywords
- hepatitis C, viral kinetics, antiviral response, Genotype 1 or 4
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IFN alfa-2b XL 27 MUI + RibavirinDrug
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 + RibavirinDrug
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 + RibavirinDrug
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 group | Role | What they receive |
|---|---|---|
| GP1N IFN alfa-2bXL 27 MUI + Ribavirin | Experimental | IFN alfa-2bXL 27 MUI, powder and solvent for solution injection Receives: Drug: IFN alfa-2b XL 27 MUI + Ribavirin |
| GP2N IFN alfa-2b XL 36 MUI + Ribavirin | Experimental | IFN alfa-2b XL 36 MUI, powder and solvent for solution injection Receives: Drug: IFN alfa-2b XL 36 MUI + Ribavirin |
| GP3N IFN peg alfa-2b 1.5 µg/kg + Ribavirin | Active comparator | IFN peg alfa-2b 1.5 µg/kg,administered once a week for 12 weeks by subcutaneous injections Receives: Drug: IFN peg alfa-2b 1.5 µg/kg + Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Week 4 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2009 (estimated)
- Study startMar 2010
- Primary completionSep 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- Flamel Technologies
- Responsible party
- Sponsor
- Investigators
- Christian TREPO, MD, Principal investigator, Hôpital de la Croix Rousse, Service d'Hépato-Gastro-Entérologie, 69004 Lyon - FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01010646
- Sponsor's protocol ID
- 2009-015121-37
- Other IDs
- ANRS HC 23 COAT-IFN, 2009
- Acronym
- COAT IFN
- Status last verified
- Sep 2013
- First submitted
- 9 Nov 2009
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01010646
- Acronym / sponsor ID
- COAT IFN / 2009-015121-37
- Conditions
- Chronic Hepatitis C
- Keywords
- hepatitis C, viral kinetics, antiviral response, Genotype 1 or 4
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- Flamel Technologies
- Study start
- Mar 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 10 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GP1N IFN alfa-2bXL 27 MUI + Ribavirin | Experimental | Drug: IFN alfa-2b XL 27 MUI + RibavirinIFN alfa-2bXL 27 MUI, powder and solvent for solution injection |
| GP2N IFN alfa-2b XL 36 MUI + Ribavirin | Experimental | Drug: IFN alfa-2b XL 36 MUI + RibavirinIFN alfa-2b XL 36 MUI, powder and solvent for solution injection |
| GP3N IFN peg alfa-2b 1.5 µg/kg + Ribavirin | Active comparator | Drug: IFN peg alfa-2b 1.5 µg/kg + RibavirinIFN peg alfa-2b 1.5 µg/kg,administered once a week for 12 weeks by subcutaneous injections |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- History of solid organ transplantation
- Severe systemic infection, uncontrolled diabetes, cancers, associated liver disease
- General anesthesia or recent blood transfusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IFN alfa-2b XL 27 MUI + RibavirinIFN 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 | GP1N IFN alfa-2bXL 27 MUI + Ribavirin |
| IFN alfa-2b XL 36 MUI + RibavirinIFN 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 | GP2N IFN alfa-2b XL 36 MUI + Ribavirin |
| IFN peg alfa-2b 1.5 µg/kg + RibavirinIFN 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 | Drug | GP3N IFN peg alfa-2b 1.5 µg/kg + Ribavirin |
Primary outcome
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
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- BackgroundTrepo, 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.
- French National Agency for Research on AIDS and Viral Hepatitis websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian TREPO, MD principal investigator
Hôpital de la Croix Rousse, Service d'Hépato-Gastro-Entérologie, 69004 Lyon - FRANCE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IFN alfa-2b XL 27 MUI + Ribavirin, IFN alfa-2b XL 36 MUI + Ribavirin and IFN peg alfa-2b 1.5 µg/kg + Ribavirin in people with Chronic Hepatitis C, run by ANRS, Emerging Infectious Diseases at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01010646, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.