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    Summary
    EudraCT Number:2022-003287-25
    Sponsor's Protocol Code Number:2018-002863-24,2022-003287-25
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2023-02-09
    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 ConcernedSweden - MPA
    A.2EudraCT number2022-003287-25
    A.3Full title of the trial
    Intralesional steroid injections to prevent refractory strictures in patients with esophageal atresia - a randomized controlled trial
    Lokal steroidinjektion i anastomosstriktur efter esofagusatresioperation: en multicenter randomiserad klinisk studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Is intralesional steroid injection effective in treating recurrent stricture following reconstruction of esophageal malformation in children?
    Kan återkommande strikturer förhindras genom injektion av steroider hos barn som opererats för missbildning i matstrupen?
    A.3.2Name or abbreviated title of the trial where available
    STEPS-EA trial
    A.4.1Sponsor's protocol code number2018-002863-24,2022-003287-25
    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 University Medical Center - Sophia Childrens 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 supportJerringfonden
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportSophia Foundation
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus MC
    B.5.2Functional name of contact pointCoordinating investigator
    B.5.3 Address:
    B.5.3.1Street AddressDr.Molewaterplein 40
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015 GD
    B.5.3.4CountryNetherlands
    B.5.4Telephone number003110703 61 16
    B.5.6E-mailsteps.ea@erasmusms.nl
    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-T 40 mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb AB Box 1172 171 23 Solna
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 T 40 mg/ml
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralesional use
    Infiltration
    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 Yes
    D.3.11.13.1Other medicinal product typeAnti-inflammatory and immunomodulatory drug used for numerous inflammatory conditions and to modulate hypertrophic scars.
    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
    Recurrent anastomotic strictures in the esophagus following surgical repair with primary anastomosis of esophageal atresia in neonates.
    E.1.1.1Medical condition in easily understood language
    Stricture (narrowing) of the esophagus due to scarring may develop following surgical repair in children born with discontinuity of the esophagus.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    This study aims to provide evidence regarding the beneficial effect of local steroid injection in anastomotic strictures following reconstructed esophageal atresia. The specific research questions are: (1) do intralesional steroid injection prevent refractory strictures in children with EA, and (2) do intralesional steroid injection reduce the number of dilatations needed?
    E.2.2Secondary objectives of the trial
    Secondary aims include the treatment effect on dysphagia, stricture characteristics, serum cortisol levels and potential systemic effects of steroid injection, co-medication and cost-benefit analysis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Children with esophageal atresia type C (Gross C, the most common form) repaired with primary anastomosis, that are considered for a third dilatation
    E.4Principal exclusion criteria
    1. Children < 3 months of age.
    2. No informed consent obtained prior to intervention
    3. Not suitable for endoscopic procedure using standard pediatric endoscopic equipment.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome parameter is the 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.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation of primary outcome will be 6 months after intervention.
    E.5.2Secondary end point(s)
    The secondary outcome parameters are:
    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 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 relative change in length of the esophageal stricture after the 3rd dilatation compared to the length before the 3rd dilatation.
    6) The use of co-medication (e.g. antacids) during the study period.
    7) 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.
    8) Total costs of the treatment, including medical and non-medical costs.
    9) Incremental costs per refractory stricture prevented and incremental costs per additional dysphagia-free patient.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaluation of secondary outcomes will be 6 months after intervention.
    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 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
    Standard treatment protocol including balloon dilatation of stricture but without steroid injection
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    LVLS
    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 years6
    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: 110
    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.1.3Elderly (>=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
    Study population is newborn children age 3 months or older, in need of third dilatation after reconstruction of esophageal atresia. I.e. expected age 3-18 months. Consent from study subject is not possible to achieve.
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Newborn children with advanced and potentially life-threatening congenital condition
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    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)
    When the follow-up period of 6 months after intervention has passed, the patient continue in the standard follow-up program applicable for all patients treated with surgical reconstruction of esophageal atresia (The Swedish national follow-up program for esophageal atresia).
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation ERNICA - European Reference Network Inherited and Congenital Anomalies
    G.4.3.4Network Country Netherlands
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2023-04-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-12-12
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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