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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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:2005-002937-11
    Sponsor's Protocol Code Number:ANRS HC 15
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2007-06-20
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2005-002937-11
    A.3Full title of the trial
    Etude randomisée, en double insu et multicentrique de l'association Interferon pégylé alpha 2b-Ribavirine versus l'association Interferon pégylé alpha 2b-placebo dans le traitement au long cours (3 ans) de la fibrose hépatique chez les patients non répondeurs ayant une hépatite virale chronique C.
    A.3.2Name or abbreviated title of the trial where available
    NRfi
    A.4.1Sponsor's protocol code numberANRS HC 15
    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 (Agence Nationale de Recherche sur le SIDA et les hépatites virales)
    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 Yes
    D.2.1.1.1Trade name PegIntron 50 et 100 µg
    D.2.1.1.2Name of the Marketing Authorisation holderShering-Plough
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Information not present in EudraCT
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePegIntron
    D.3.2Product code Pegintron alpha-2b (DCI approuvée)
    D.3.4Pharmaceutical form Concentrate 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.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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 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 No
    D.IMP: 2
    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 Rebetol
    D.2.1.1.2Name of the Marketing Authorisation holderShering-Plough
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Information not present in EudraCT
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRebetol
    D.3.2Product code Ribavirine (DCI approuvée)
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    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 No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule*
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hepatic fibrosis in non responders patients with chronic hepatitis C
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10019668
    E.1.2Term Hepatic fibrosis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Montrer l'intérêt de l'association Interferon pégylé alpha 2b-Ribavirine par rapport à l'Interferon pégylé alpha 2b seul dans le traitement au long cours (3 ans) de la fibrose hépatique des malades ayant une hépatite chronique virale C.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Adulte de 18 ans ou plus,
    -porteur d’une infection virale C définie par la présence dans le sérum d'anticorps anti-VHC détectés en ELISA et d'ARN VHC,
    -n’ayant pas répondu à un traitement préalable associant interféron – ribavirine,
    . Le traitement préalable par interféron devra avoir été mené à la dose minimale de 0.5 µg/kg/semaine pour l'interféron pégylé alpha 2b ou de 90 µg/semaine pour l'interféron pégylé alpha 2a. Les malades ayant été traités par des schémas d’interféron quotidien à une dose minimum de 3 millions d'unités par jour pourront aussi être inclus.
    . La non réponse au traitement préalable est définie par :
    - soit la persistance de l’ARN VHC après la 24ème semaine de traitement (cette définition incluant les malades dénommés «échappeurs» ayant eu une négativation transitoire de l’ARN viral C sous traitement),
    - soit l'absence de chute supérieure ou égale à 2 log10 de la charge virale après la 12ème semaine de traitement ;

    -ayant une hépatite chronique active avec un score de fibrose de Métavir ≥ 2 sur une biopsie hépatique de référence permettant une détermination fiable du score de fibrose de Métavir, effectuée moins de 12 mois avant la date d'inclusion et après la fin du dernier traitement antiviral,
    -ayant une augmentation des ALAT supérieure à la limite supérieure du laboratoire à la date d'inclusion,
    -pour lequel un traitement suspensif par interféron pégylé a été retenu,
    -acceptant une biopsie de fin de protocole,
    -ayant un test de grossesse négatif (pour les femmes),
    -ayant donné un consentement libre, éclairé et par écrit.
    E.4Principal exclusion criteria
    1.Antécédents
    -Antécédents de complications de la maladie hépatique (hémorragie digestive par hypertension portale, ascite, encéphalopathie hépatique).
    -Antécédent de transplantation d'organe.
    -Antécédent de comitialité sévère.
    -Antécédent de troubles psychiatriques graves, notamment de tentative de suicide ou de dépression ayant nécessité une hospitalisation ou un traitement antidépresseur sur une période de plus de 6 mois.
    -Toxicomanie non sevrée depuis au moins 12 mois.

    2.Maladies actuelles ou état physiologique actuel
    -Affection susceptible de provoquer une atteinte hépatique indépendamment du VHC : Ag Hbs (+), HIV (+), hémochromatose C282Y +/+, déficit en alpha-1 antitrypsine, maladie de Wilson, hépatite auto-immune, hépatite médicamenteuse, hépatite alcoolique.
    -Carcinome hépatocellulaire défini par l'existence d'un syndrome tumoral hépatique ou d'une élévation de l'alpha-foeto protéine > 100 µg/L.
    -Pathologie cardio-vasculaire non équilibrée sous traitement : insuffisance coronarienne, insuffisance cardiaque, hypertension artérielle, troubles du rythme ventriculaires.
    -Diabète non équilibré sous traitement.
    -Rétinopathie significative (nécessité d'un fond d'œil lors de l'inclusion en cas d'hypertension artérielle ou de diabète).
    -Maladie thyroïdienne non équilibrée sous traitement (TSH anormale).
    -Maladie épileptique et/ou anomalies fonctionnelles du système nerveux central.
    -Maladie auto-immune ou présence d'auto-anticorps à un titre > 1/500 (dosage datant de moins de 12 mois des anticorps anti-noyaux, anti-muscles lisses, anti-mitochondries, anti-LKM).
    -Consommation régulière d'alcool > 30 g/jour chez la femme (3 verres) et 40 g/jour (4 verres) chez l’homme.
    -Grossesse (nécessité d’un dosage de bêta-HCG avant la mise en route du traitement), allaitement, absence de contraception efficace chez la femme non ménopausée.

    3.Critères biologiques
    -Hémoglobine < 12 g/dl.
    -Plaquettes < 50 000 /mm3.
    -Polynucléaires neutrophiles < 1200 /mm3.
    -Insuffisance hépatocellulaire sévère (TP < 60%).
    -Insuffisance rénale (clairance de la créatinine < 50 ml/mn).

    4.Critères liés au traitement
    -Traitement associé par immunosuppresseurs, corticoïdes, antiviraux autres que ceux de l’étude.
    -Traitement par des médicaments pouvant avoir une influence démontrée ou suspectée sur la fibrose (acide ursodésoxycholique, antagonistes des récepteurs de l’angiotensine II, colchicine, D-pénicillamine, méthotrexate, pentoxifylline, prostaglandines, silymarine, vitamine A, vitamine E).
    -Traitement par anticonvulsivants.
    -Intolérance à l'interféron lors du dernier traitement antiviral.
    E.5 End points
    E.5.1Primary end point(s)
    Critère principal : pourcentage de patients ayant une amélioration d'au moins un point du score de fibrose selon la classification de Métavir antre la biopsie initiale et la biopsie finale.
    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 Information not present in EudraCT
    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) No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA48
    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 Information not present in EudraCT
    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
    En cas d'intolérance aux traitements de l'étude non résolue par les schémas d'adaptation posologique proposés, de transplantation hépatique, de complications graves de la maladie hépatique, de survenue d'un carcinome hépatocellulaire ou de demande expresse du malade, le traitement de l'étude pourra être arrêté par l'investigateur mais les malades seront dans la mesure du possible suivis et évalués pendant toute la durée de l'étude selon les modalités prévues par le protocole.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 454
    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 Decision2007-06-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-01-23
    P. End of Trial
    P.End of Trial StatusOngoing
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