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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2009-015121-37
    Sponsor's Protocol Code Number:ANRS HC 23
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-10-23
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2009-015121-37
    A.3Full title of the trial
    Etude multicentrique randomisée ouverte comparant la réduction virale et la tolérance
    de l’association IFN alpha-2b XL + ribavirine versus IFN peg alpha-2b + ribavirine chez des
    patients atteints d’hépatite chronique C de génotype 1
    A.3.2Name or abbreviated title of the trial where available
    COAT-IFN
    A.4.1Sponsor's protocol code numberANRS HC 23
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorANRS
    B.1.3.4CountryFrance, Metropolitan
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameIFN alpha 2b XL
    D.3.2Product code FT108
    D.3.4Pharmaceutical form Injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINTERFERON ALFA-2B
    D.3.9.1CAS number 99210-65-8
    D.3.9.3Other descriptive nameINTERFERON ALFA-2B
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.3
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Information not present in EudraCT
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name VIRAFERON PEG
    D.2.1.1.2Name of the Marketing Authorisation holderSHERING PLOUGH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPEGINTERFERON ALFA-2B
    D.3.9.1CAS number 215647-85-1
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Information not present in EudraCT
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Copegus
    D.2.1.1.2Name of the Marketing Authorisation holderROCHE
    D.2.1.2Country which granted the Marketing AuthorisationFrance, Metropolitan
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code RO 20-9963
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRIBAVIRIN
    D.3.9.1CAS number 36791-04-5
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Evaluation de l’activité antivirale d’injections hebdomadaires d’un nouvel interféron α-2b à libération prolongée formulé avec Medusa® (IFNα-2bXL) chez des patients atteints d’hépatite chronique virale C génotype 1.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10008912
    E.1.2Term Chronic hepatitis C
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluer l’activité antivirale, par la réduction de la charge virale à la fin de la quatrième et de la douzième semaine, d’injections hebdomadaires répétées pendant 12 semaines d’IFN alfa-2b XL 27 MUI, IFN alfa-2b XL 36 MUI et du produit commercialisé de référence (Viraferon®Peg 1.5µg/kg), en association à la ribavirine, chez des patients atteints d’hépatite chronique virale C, soit naïfs (n’ayant jamais reçu d’IFNα), soit non-répondeurs à un traitement antérieur par interféron alfa pegylé associé à la ribavirine.
    E.2.2Secondary objectives of the trial
    - Pourcentage de patients présentant une réponse virologique précoce (réduction d’au moins 2 Log de la charge virale) à la fin de la 12ème semaine,
    - Pourcentage de patients présentant une réponse virologique précoce complète (charge virale < 15 UI) à la fin de la 12ème semaine,
    - Pourcentage de patients présentant une réponse virologique rapide (charge virale < 15 UI) à la fin de la 4ème semaine,
    - Confirmer la sécurité et la tolérance cliniques et biologique de l’IFN alfa-2b XL 27 MUI et de l’IFN alfa-2b XL 36 MUI en administrations répétées, en association à la ribavirine,
    - Profils de tolérance d’IFN alfa-2b XL 27 et 36 MUI, par rapport au Viraferon®Peg 1.5µg/kg),
    - Evaluer les paramètres pharmacocinétiques après la première administration de l’IFN alpha-2b XL 27 MUI, de l’IFN alfa-2b XL 36 MUI, et du Viraferon®Peg 1.5µg/kg, en association à la ribavirine, chez des patients atteints d’hépatite C chronique.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Hommes ou femmes atteints d’une hépatite chronique C de génotype 1, diagnostiquée par la présence d’ARN viral positif
    - Patient :
    . Naïf de traitement par interféron Alfa,
    Ou
    . Non-répondeur à un traitement préalable par interféron α pegylé + ribavirin,
    - Agé de 18 à 65 ans (bornes incluses), et ayant un poids corporel compris entre 45 et 100 Kg (bornes incluses)
    - Ne présentant pas de contre-indication absolue à l’interféron α ou à la ribavirine
    - Femmes en âge de procréer présentant un test de grossesse négatif à l'inclusion.
    - Hommes et femmes acceptant de mettre en œuvre une contraception efficace du couple depuis la sélection, tout au long du traitement et pendant 7 mois après l'arrêt du traitement, et acceptant de pratiquer des tests de grossesse mensuels pendant cette même durée.
    - Peuvent également être inclus, le patient chirurgicalement stérile ou dont le (la) partenaire est chirurgicalement stérile (hystérectomie ou ligature tubaire bilatérale, ou vasectomie) et acceptant de pratiquer (pour les femmes) ou faire pratiquer (à sa partenaire, pour les hommes) des tests de grossesse mensuels, tout au long du traitement et pendant 7 mois après l'arrêt du traitement.
    - Paramètres hématologiques dans les valeurs acceptables pour initier un traitement par IFN/ribavirine
    - Absence de signe d’hépathopatie chronique évoluée
    - Absence de signe d’insuffisance rénale modérée ou sévère
    - Patient ayant une sérologie négative pour l’hépatite B (AgHBs) et les anticorps anti-VIH
    - Absence d’anomalie électrocardiographique
    E.4Principal exclusion criteria
    - Toute contre-indication absolue à l’IFNα ou à la ribavirine, notamment hypersensibilité connue à l’un des produits ou de ses composants
    - Indication absolue à un médicament ayant potentiellement un impact significatif sur l’évaluation de l’efficacité ou de la tolérance du produit à l’étude (érythropoiétine, analogues nucléosidiques –didanosine, abacavir, zidovudine–, traitement immunomodulateur)
    - Traitement par IFN ou Ribavirine dans les 3 mois précédant l’inclusion
    - Patient ayant préalablement reçu de l’IFN-albumine
    - Prise de produits d’auto-médication, en dehors des vitamines non-spécifiques dans les 2 semaines précédant la première administration du traitement de l’étude, à l’exception des contraceptifs, ou intention de le faire pendant la période d’étude. La prise occasionnelle de paracetamol est autorisée pendant toute la durée de l’étude, avec un maximum de 3 g par jour
    - Patient présentant l’une des anomalies suivantes : Anticorps antinucléaires > 320 IU/mL, Anticorps anti-muscle lisse > 1:50, Anticorps anti-thyroperoxidase positif, Anomalie de la T4 libre ou de la TSH.
    - Antécédent de transplantation d’organe et/ou traitement immunosuppresseur (corticothérapie, cyclosporine et dérivés)
    - Patient ayant un test de dépistage de l’hépatite B (Atg HBs) ou du VIH positif
    - Toute infection systémique grave, selon l’opinion de l’investigateur, autre que l’hépatite C survenue dans les 4 semaines précédant la première administration de l’étude
    - Antécédent ou présence d’un diabète mal équilibré, d’un cancer diagnostiqué depuis moins de 5 ans, d’une maladie hépatique non due au VHC (hémochromatose, deficit en alpha-1 antitrypsine, maladie de Wilson, hépatite auto-immune, …) ou d’une anomalie ou d’une pathologie cardiaque, respiratoire, métabolique, rénale, gastrointestinale, endocrinologique, hématologique, neurologique, ou psychiatrique significative ou mettant en jeu le pronostic vital à 12 mois.
    E.5 End points
    E.5.1Primary end point(s)
    Le critère de jugement principal est la réduction de charge virale à la fin de la quatrième et de la douzième semaine mesurée en PCR temps réel au seuil de 15 UI/ml.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned20
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days15
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state84
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2009-12-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-10-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-06-26
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