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    Summary
    EudraCT Number:2018-002863-24
    Sponsor's Protocol Code Number:2020_97
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-02-24
    Trial 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 number2018-002863-24
    A.3Full title of the trial
    Intralesional steroids injections to prevent refractory strictures in patients with esophageal atresia - a randomized controlled tiral
    Injections intralésionnelles de stéroides pour prévenir les sténoses réfractiares chez les patients atteints d'atrésie de l'oesophage - essai controlé randomisé
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Intralesional steroids injections to prevent refractory strictures in patients with esophageal atresia - a randomized controlled tiral
    Injections intralésionnelles de stéroides pour prévenir les sténoses réfractiares chez les patients atteints d'atrésie de l'oesophage - essai controlé randomisé
    A.3.2Name or abbreviated title of the trial where available
    STEPS-EA
    A.4.1Sponsor's protocol code number2020_97
    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 SponsorErasmus Universitu Medical Center - Sophia Children's Hospital
    B.1.3.4CountryNetherlands
    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 supportThe Sophia Fund (Sophia Kinderziekenhuis Fonds)
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre Hopsitalier et universitaire de Lille
    B.5.2Functional name of contact pointAramatoulaye SAMBOU (ARC
    B.5.3 Address:
    B.5.3.1Street Address6 rue du Pr Laguesse
    B.5.3.2Town/ cityLille
    B.5.3.3Post code59037
    B.5.3.4CountryFrance
    B.5.4Telephone number00330320444145
    B.5.5Fax number00330320445711
    B.5.6E-mailDRC@chru-lille.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 Kenacort-A 10 mg-ml
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Belgium S.A.
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameKenacort-A
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralesional 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    refractory strictures in patients with esophageal atresia
    sténose réfrataire chez les pateints atteinst d'atrésie de l'oesophage
    E.1.1.1Medical condition in easily understood language
    refractory strictures in patients with esophageal atresia
    sténose réfrataire chez les pateints atteinst d'atrésie de l'oesophage
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10021530
    E.1.2Term Imperforate oesophagus
    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
    evaluate whether intralesional injection with steroids in children with EA can prevent the development of a refractory stricture, and thus can minimize the total number of dilatations within 28 days interval.
    évaluer si l’injection intralésionnelle de stéroïdes chez les enfants atteints d’EA peut prévenir le développement d’une sténose éfractaire et ainsi réduire le nombre total de dilatations dans un intervalle de 28 jours.
    E.2.2Secondary objectives of the trial
    - compare between the two groups the level of dysphagia and the child’s eating behavior at the end of the follow up period.
    - compare between the two groups the efficacy of dilatation with or without intralesional steroid injections on the luminal diameter and the stricture length.
    - evaluate a possible influence of co-medication (e.g. antacids) on stricture formation.
    - analyze the possible systemic effects of a one-time intralesional steroid injection.
    - analyze the cost-effectiveness of the use of intralesional steroid injections to prevent refractory strictures.
    - comparer entre les deux groupes le niveau de dysphagie et le comportement alimentaire de l’enfant à la fin de la période de suivi.
    - comparer entre les deux groupes l’efficacité de la dilatation avec ou sans injections intralésionnelles de stéroïdes sur le diamètre luminal et la longueur de la striction.
    - évaluer l’influence possible de la co-médication (p. ex., antiacides) sur la formation de strictures.
    - analyser les effets systémiques possibles d’une injection unique de stéroïdes intralésionnels.
    - analyser la rentabilité de l’utilisation d’injections intralésionnelles de stéroïdes pour prévenir les sténoses réfractaires.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Children with EA type C who underwent primary anastomotic surgery within the first days of life
    - Age 3 months at the time of the 3rd dilatation
    - In need of a 3rd dilatation
    - Written informed consent by both parents or legal representatives, if applicable
    - Enfants atteints d’AE de type C qui ont subi une chirurgie anastomotique primaire au cours des premiers jours de leur vie
    - Age ≥ 3 mois au moment de la 3e dilatation
    - Nécessité d’une 3e dilatation
    - Consentement éclairé écrit signé des deux parents ou représentants légaux, le cas échéant
    E.4Principal exclusion criteria
    - Age <3 months
    - Known inability from previous dilatations to use an endoscope with a size of 5.8 mm
    - No parental written informed consent
    - age <3 mois
    - Impossibilté à la suite de dilatations antérieures, d’utiliser un endoscope de 5,8 mm
    - absence de consentement signé
    E.5 End points
    E.5.1Primary end point(s)
    total number of dilatations per patient within 28 days interval required during the study period, defined as the period from the day of the 3rd dilatation until 6 months later.
    nombre total de dilatations par patient dans un intervalle de 28 jours requis pendant la période de l’étude, défini comme la période allant du jour de la 3e dilatation jusqu’à 6 mois plus tard.
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 days
    28 jours
    E.5.2Secondary end point(s)
    1) Total number of dilatations within the study period, regardless of the interval.
    2) Interval (in weeks) between the start of the study and the last dilatation procedure within the study period.
    3) Montreal Feeding Scale (in Dutch Screeningslijst Eetgedrag Peuters (SEP)), measured at the end of the follow up period.
    4) The relative change in maximal luminal diameter after the 3rd dilatation compared to the diameter before the 3rd dilatation.
    5) The use of co-medication (e.g. antacids) during the study period.
    6) The mean cortisol level over the first three months after the 3rd dilatation, measured in a hair sample taken at the end of the follow up period.
    7) Total costs of the treatment, including medical and non-medical costs.
    1) Nombre total de dilatations au cours de la période d’étude, peu importe l’intervalle.
    2) Intervalle (en semaines) entre le début de l’étude et la dernière procédure de dilatation au cours de la période de l’étude.
    3) Échelle d’alimentation de Montréal (dans Dutch Screeningslijst Eetgedrag Peuters (SEP)), mesurée à la fin de la période de suivi.
    4) Le changement relatif du diamètre luminal maximal après la 3e dilatation par rapport au diamètre avant la 3e dilatation.
    5) L’utilisation de co-médicaments (p. ex., antiacides) pendant la période de l’étude.
    6) La concentration moyenne de cortisol au cours des trois premiers mois suivant la 3e dilatation, mesurée dans un échantillon de cheveux prélevé à la fin de la période de suivi.
    7) Coûts totaux du traitement, y compris les coûts médicaux et non médicaux.
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 months
    6 mois
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    prise en charge habituelle
    usual care
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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 Yes
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Croatia
    Lithuania
    European Union
    United Kingdom
    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
    LAST VISIT OF THE LAST SUBJECT
    dernière visite du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 110
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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
    infant
    nourrisson
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    infant
    nourisson
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    F.4.2.2In the whole clinical trial 110
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    usual care
    prise en charge habituelle
    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 Decision2021-07-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-12
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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