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    Summary
    EudraCT Number:2011-003063-30
    Sponsor's Protocol Code Number:BRD10/6-O
    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:2011-09-23
    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 number2011-003063-30
    A.3Full title of the trial
    Traitement Ciblé et Précoce du Canal Artériel du Prématuré par Ibuprofène (TRIOCAPI)
    A.3.2Name or abbreviated title of the trial where available
    TRIOCAPI
    TRIOCAPI
    A.4.1Sponsor's protocol code numberBRD10/6-O
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCHU Nantes
    B.1.3.4CountryFrance
    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 supportMinistère de la Santé - DGOS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU NANTES
    B.5.2Functional name of contact pointDirection de la Recherche
    B.5.3 Address:
    B.5.3.1Street Address5, allée de l'Ile Gloriette
    B.5.3.2Town/ cityNANTES
    B.5.3.3Post code44093
    B.5.3.4CountryFrance
    B.5.4Telephone number00332 53 48 28 84
    B.5.5Fax number00332 53 48 28 36
    B.5.6E-maildamien.fairier@chu-nantes.fr
    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 PEDEA
    D.2.1.1.2Name of the Marketing Authorisation holderOrphan Europe
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEMEA/H/C/000549
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPIntravenous 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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Les patients à inclure seront des prématurés nés entre 24 et 27 semaines et 6 jours (en SA), hospitalisés dans une unité de réanimation néonatale.
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10034130
    E.1.2Term Patent ductus arteriosus
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Augmentation de 18% du taux de survie sans infirmité motrice cérébrale à 2 ans d’âge corrigé (qui passerait ainsi de 35 à 53%) avec de l’ibuprofène administré par voie intra-veineuse entre H6 et H12 chez des enfants prématurés de moins de 28 semaines à haut risque de PCA dépisté par échocardiographie
    E.2.2Secondary objectives of the trial
    • Comparaison de l’ASQ réalisé à 24 mois d’age corrigé entre les 2 bras (placebo versus Ibuprofène) du groupe LARGE.
    • Comparaison du devenir (survie sans séquelles et autres critères d’évaluation secondaires) entre le groupe PETIT et le groupe LARGE placebo, de manière à déterminer si le critère utilisé pour le ciblage initial est discriminant.
    • Déterminer l’impact du traitement précoce ciblé du canal artériel par ibuprofène sur les autres morbidités de la prématurité : HIV, morbidité digestive, morbidité rénale, morbidité respiratoire.
    • Comparaison du devenir entre les différents stades de Mc Namara auquels les enfants symptomatiques ont eu une ligature chirurgicale du canal artériel (avec ajustement sur le fait d’avoir reçu préalablement un traitement médical)
    • Analyse du sous groupe des prematurés avec un Z-score du poids de naissance inférieur à -1 / analyse global en ajustant sur le Z-score du poids de naissance.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Naissance survenant avant 28 SA
    - Echocardiographies possible avant 12 heures de vie
    - Obtention d’un consentement parental éclairé
    - Bénéficiaire d’un régime de sécurité sociale
    E.4Principal exclusion criteria
    - Hémorragie intraventriculaire grade 3-4 lors de l’évaluation initiale
    - Instabilité clinique pouvant conduire à un décès rapide (critère laissé à la libre appréciation de l’investigateur)
    - Anomalies congénitales susceptibles d’influencer le devenir psychomoteur
    - Cardiopathie congénitale
    - Shunt droite-gauche ductal pendant plus d’un tiers du cycle cardiaque témoignant d’une hypertension artérielle pulmonaire.
    - Contre-indication à l’ibuprofène (taux de plaquettes < 50 000/mm3, administration maternelle d’anti-inflammatoires non stéroidiens dans les 6 semaines précédant l’accouchement, infection mettant en jeu le pronostic vital, hémorragie gastro-intestinale, troubles de la coagulation, insuffisance rénale significative, entérocolite ulcéronécrosante connue ou suspectée, élévation prononcée de la bilirubine)
    - Impossibilité de démarrer le traitement avant H12
    - Refus parental
    - Patient participant à un autre essai thérapeutique
    - Impossibilité d’assurer le suivi pendant la durée de l’essai
    E.5 End points
    E.5.1Primary end point(s)
    Critère combiné : survie sans infirmité motrice cérébrale et avec un quotient de développement > 85 (score de Brunet-Lézine) à 2 ans d’âge corrigé.
    E.5.2Secondary end point(s)
    - Mortalité
    - HIV grade 3-4 (classification de Papile)38
    - Leucomalacie périventriculaire
    - Besoin de traitement médical et/ou chirurgical du canal en ouvert
    - Nombre total de doses d’ibuprofène
    - Effets secondaires de l’ibuprofène
     Insuffisance rénale (élévation de la créatinine > 150 micromol/l, oligurie < 1 ml/kg/h pendant plus de 12 heures)
     Hémorragie digestive, présence de sang frais dans les aspirations gastriques
    - Perforation digestive isolée
    - ECUN de stade > 2 dans la classification de Bell 39
    - Hypertension artérielle pulmonaire documentée par échographie
    - Hémorragie pulmonaire
    - Rétinopathie de la prématurité
    - Sepsis (antibiothérapie supérieure à 5 jours)
    - Type et durée de ventilation mécanique
    - Durée de CPAP
    - Durée de l’oxygéno-dépendance
    - Dysplasie broncho-pulmonaire (définie selon les critères de Walsh)
    - Durée d’hospitalisation
    Mesure de l’ASQ-score à 24 mois d’âge corrigé
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    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.8.2.4Number of treatment arms in the trial2
    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 concerned10
    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 No
    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 years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 385
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 385
    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) No
    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 Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Premature baby
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state385
    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 Decision2011-12-28
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-06-21
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