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    Summary
    EudraCT Number:2015-003996-32
    Sponsor's Protocol Code Number:69HCL14-0447
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-12-04
    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 number2015-003996-32
    A.3Full title of the trial
    Multicentric evaluation of in utero dexamethasone (DEX) on the cognitive development of children at risk of Congenital Adrenal Hyperplasia - PRENATAL DEX Study
    Etude PRENATAL DEX - Evaluation multicentrique de l’effet de la Dexamethasone in utero sur le développement cognitif des enfants à risque d’hyperplasie congénitale des surrénales
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multicentric evaluation of in utero dexamethasone (DEX) on the cognitive development of children at risk of Congenital Adrenal Hyperplasia - PRENATAL DEX Study
    Etude PRENATAL DEX - Evaluation multicentrique de l’effet de la Dexamethasone in utero sur le développement cognitif des enfants à risque d’hyperplasie congénitale des surrénales
    A.3.2Name or abbreviated title of the trial where available
    PRENATAL DEX
    PRENATAL DEX
    A.4.1Sponsor's protocol code number69HCL14-0447
    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 SponsorHospices Civils de Lyon
    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 supportHospices Civils de Lyon
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospices Civils de Lyon
    B.5.2Functional name of contact pointIUNG
    B.5.3 Address:
    B.5.3.1Street Address3 Quai des Celestins
    B.5.3.2Town/ cityLYON
    B.5.3.3Post code69002
    B.5.3.4CountryFrance
    B.5.4Telephone number330472406824
    B.5.5Fax number330472115190
    B.5.6E-mailannie.iung@chu-lyon.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 Dectancyl
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Aventis France
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    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
    Patient with Congenital Adrenal Hyperplasia (CAH) or sibling of a CAH patient .
    Patient no connection with Congenital Adrenal Hyperplasia
    Patient atteint d'hyperplasie congénitale des surrénales (HCS) ou fratrie d’un patient HCS.
    Patient sans lien avec l'hyperplasie congénitale des surrénales
    E.1.1.1Medical condition in easily understood language
    Patient with Congenital Adrenal Hyperplasia (CAH) or sibling of a CAH patient .
    Patient no connection with Congenital Adrenal Hyperplasia
    Patient atteint d'hyperplasie congénitale des surrénales (HCS) ou fratrie d’un patient HCS.
    Patient sans lien avec l'hyperplasie congénitale des surrénales
    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 18.1
    E.1.2Level PT
    E.1.2Classification code 10061630
    E.1.2Term Adrenogenital syndrome
    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
    To assess the neurocognitive effects of in utero treatment with DEX (Dexamethasone) on children who did not need treatment: non-CAH girls and boys treated in utero with DEX who consequently received excessive glucocorticoids during fetal life, in comparison with non-CAH and untreated girls and boys (siblings of CAH and control population).
    Evaluer les effets neurocognitifs du traitement par DEX in utero chez les enfants à risque d’HCS qui ne nécessitaient pas de traitement (filles et garçons non atteints) et qui de fait ont reçu un excès de glucocorticoïdes durant la vie foetale
    E.2.2Secondary objectives of the trial
    - To assess the emotional effects of in utero treatment with DEX on children who did not need treatment:n comparison with non-CAH and untreated patients (siblings of CAH and control population).
    -To determine the benefits of DEX for CAH compared to its adverse effects, namely to:
    - Assess the neurocognitive profile of CAH boys and girls treated with DEX in comparison to CAH girls and boys not treated with DEX with hyperandrogenism with adrenal origin: to evaluate the benefits of DEX in terms of brain development achieved by controlling hyperandrogenism;
    - Determine the impact of the disease by assessing CAH children not treated with DEX in terms of emotional cues such as social anxiety, self-esteem and mood during their development, in comparison with non-CAH girls and boys not treated with DEX (siblings of CAH and control population);
    - Assess the benefits of in utero DEX treatment on the prevention of the virilization of the external genitalia in CAH girls
    - Evaluation du profil neurocognitif des enfants HCS traités par DEX en comparaison avec des enfants HCS non traités, ces derniers ayant été soumis pendant la vie fœtale à l’hyperandrogénisme d’origine surrénalienne décrite comme pouvant avoir un impact sur le développement cérébral
    - La détermination de l’impact de la maladie HCS : les indicateurs émotionnels tels que l’anxiété sociale, l’estime de soi et l’humeur seront évalués chez les enfants HCS non traités et comparés aux enfants non HCS non traités (fratrie d’enfants HCS et population contrôle).
    -L’évaluation des bénéfices du traitement par DEX in utero dans la prévention de la virilisation des organes génitaux extérieurs chez les filles HCS.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male or female
    - Patient with Congenital Adrenal Hyperplasia or sibling of a CAH patient
    - Age: 6 to 15 years (at the time of inclusion)
    - The subject's legal representatives have understood the information note/informed consent form, obtained answers to all their questions and have given signed, written, informed consent
    - Subject with health insurance

    For Schoolchildren:
    - Male or female
    - With no connection with Congenital Adrenal Hyperplasia
    - Age: 6 to 15 years (at the time of inclusion)
    - The subject's legal representatives have understood the information note/informed consent form, obtained answers to all their questions and have given signed, written, informed consent
    - Subject with health insurance
    Critères d’inclusion enfants liés à la maladie HCS :
    1/ Fille ou garçon
    2/ Patient atteint d'hyperplasie congénitale des surrénales (HCS) ou fratrie d’un patient HCS
    3/ Age compris entre 6 et 15 ans (au moment de l’inclusion)
    4/ Signature du consentement éclairé par le patient ou son représentant légal
    5/ Patient affilié ou bénéficiaire d’un régime de sécurité sociale
    Critères d’inclusion groupe contrôle scolarisé:
    1/ Fille ou garçon
    2/ Sans lien avec l'hyperplasie congénitale des surrénales
    3/ Age compris entre 6 et 15 ans (au moment de l’inclusion)
    4/ Signature du consentement éclairé par le patient ou son représentant légal
    5/ Patient affilié ou bénéficiaire d’un régime de sécurité sociale
    E.4Principal exclusion criteria
    - Patient/Subject with another genetic disease
    - Patient/Subject with known neuropsychology disease(s)
    - Patient/Subject whose mother has received another treatment during her pregnancy with possible known adverse events on the neuropsychological development of the child
    - Enfant présentant une autre maladie génétique
    - Enfant présentant un (des) trouble(s) neuropsychologique(s) connu(s)
    - Enfant dont la mère a reçu durant sa grossesse un traitement ayant des potentiels effets secondaires connus sur le développement neuropsychologique des enfants
    E.5 End points
    E.5.1Primary end point(s)
    IQ assessment (four index)
    Evaluation du score de QI total (test WISC IV) : différence de QI évalué par quatre indices considérés comme mesure répétée
    E.5.1.1Timepoint(s) of evaluation of this end point
    visit 2
    visite 2
    E.5.2Secondary end point(s)
    - Neuropsychological assessments
    - Emotional assessment
    - Evaluation of the benefits of in utero DEX in preventing or reducing the virilization of external genitalia in CAH girls
    - Profil neurocognitif des enfants évalués par les résultats aux tests neuropsychologiques de la Visite 2 (CMS, figure de Rey).
    - Profil émotionnel évalué par l’ensemble des résultats aux tests d’évaluations émotionnelles : score R-CMAS et score MDI-C. Analyse questionnaire CBCL.
    - Evaluation anatomique des organes génitaux féminins externes : mesure du tubercule génital, distance entre le périnée et l’urètre, degré de fusion des grandes lèvres, pigmentation des grandes lèvres, mesure de la distance ano-génitale
    E.5.2.1Timepoint(s) of evaluation of this end point
    v1, v2 and v3
    V1, v2 et v3
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Improve prenatal management of CAH by assessing the safety of DEX for the neuropsychological development during childhood and adolescence.
    Determine whether the temporary cessation of the prenatal use of DEX in Sweden and in the United States is justified or not.
    Reporting on the safety of in utero DEX use in terms of its impact on cognitive function would allow our study to discuss possible marketing authorization for this indication
    - Amélioration de la prise en charge prénatale des patients HCS en validant la sécurité d’utilisation du traitement DEX sur le développement neuropsychologique.
    - Sur le plan international, de déterminer si l'arrêt temporaire du traitement prénatal par DEX en Suède et aux États-Unis est justifiée ou non.
    - Si l’innocuité de l’administration in utero de DEX sur les fonctions neurocognitives, une éventuelle autorisation de commercialisation (AMM) pourrait être envisagée
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    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 No
    E.8.2.4Number of treatment arms in the trial5
    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 concerned17
    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 No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months39
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months39
    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: 400
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 400
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 400
    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 Yes
    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 state400
    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)
    None
    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 Decision2015-10-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-03
    P. End of Trial
    P.End of Trial StatusOngoing
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