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    Summary
    EudraCT Number:2016-001486-90
    Sponsor's Protocol Code Number:P150944
    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:2016-04-27
    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 number2016-001486-90
    A.3Full title of the trial
    Dose reduction of antenatal betamethasone given to prevent the neonatal complications associated with very preterm birth: a randomized, multicentre, double blind placebo-controlled non inferiority trial. BETADOSE
    Réduction de la dose anténatale de bétamethasone administrée pour prévenir les complications néonatales de la grande prématurité:Essai randomisé multicentrique en double aveugle contre placebo de non infériorité. BETADOSE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    BETADOSE : Dose reduction of antenatal betamethasone given to prevent the neonatal complications associated with very preterm birth: a randomized, multicenter, double blind placebo-controlled non inferiority trial
    BETADOSE: Réduction de la dose anténatale de bétamethasone administrée pour prévenir les complications néonatales de la grande prématurité: Essai randomisé multicentrique en double aveugle contre placebo de non infériorité
    A.3.2Name or abbreviated title of the trial where available
    BETADOSE
    A.4.1Sponsor's protocol code numberP150944
    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 SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    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 supportDGOS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.5.2Functional name of contact pointDRCD Hôpital St Louis
    B.5.3 Address:
    B.5.3.1Street Address 1 av. Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.6E-mailelodie.soler@aphp.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 CELESTENE CHRONODOSE 5,70 mg/ml, suspension injectable
    D.2.1.1.2Name of the Marketing Authorisation holderMSD 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.3.1Product nameCELESTENE CHRONODOSE 5,70 mg/ml, suspension injectable
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBétaméthasone
    D.3.9.3Other descriptive nameBétaméthasone
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5,70
    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 placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Very preterm birth
    Grande prématurité
    E.1.1.1Medical condition in easily understood language
    Very preterm birth
    Grande prématurité
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10053593
    E.1.2Term Premature baby 26 to 32 weeks
    E.1.2System Organ Class 100000004868
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the effectiveness of a 50% reduced betamethasone dose regimen to prevent severe respiratory distress syndrome (RDS) associated with very preterm birth.
    Démontrer l'efficacité d'une demi-dose de bétaméthasone pour prévenir la maladie des membranes hyalines (MMH) sévère associée à la grande prématurité
    E.2.2Secondary objectives of the trial
    To demonstrate the effectiveness of a 50% reduced betamethasone dose regimen to prevent the other neonatal complications associated with very preterm birth.
    Démontrer l'efficacité d'une demi-dose de bétaméthasone pour prévenir les autres complications néonatales associées à la grande prématurité
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Singleton pregnancy
    - Patient who has already received the first injection of betamethasone and term pregnancy <32 weeks of gestation
    - Age > or = 18 years
    - Patient with health insurance coverage
    - Grossesse monofoetale
    - Patiente ayant déjà reçu la 1ere injection de bétaméthasone et terme de grossesse <32SA
    - Age > ou = 18 ans
    - Patiente affiliée à un regime de sécurité sociale ou CMU
    E.4Principal exclusion criteria
    - Chromosomal aberrations and major fetal malformations
    - Cervical dilatation > ou = 4 cm
    - Patient who has already received a first betamethasone course
    - Anomalies chromosomiques et syndrome malformatif majeur
    - Dilatation cervicale > ou = à 4 cm
    - Patiente ayant déjà reçu une première cure de betaméthasone.
    E.5 End points
    E.5.1Primary end point(s)
    Severe respiratory distress syndrome (RDS) defined as need for exogenous intra-tracheal surfactant in the first 48 hours of life.
    Maladie des membranes hyalines (MMH) sévère définie comme un recours au surfactant exogène dans les 48 premières heures de vie.
    E.5.1.1Timepoint(s) of evaluation of this end point
    48 hours
    48 heures
    E.5.2Secondary end point(s)
    Related to the severity of RDS
    - highest appropriate fractional inspired oxygen (FiO2) in the first 48 hours of life
    - maximum appropriate Mean Airway Pressure (MAP)
    - use and duration of mechanical ventilation
    - use and duration of oxygen therapy
    - need for oxygen therapy after 36 weeks post conception

    Related to betamethasone impact on other prematurity-induced complications
    - neonatal death
    - admission to neonatal intensive care unit
    - use of inotropic support
    - air leak syndrome
    - patent ducutus arteriosus
    - necrotising enterocolitis grade > II
    - intraventricular hemorrhage and its grade
    - periventricular leukomalacia
    - use of postnatal steroids
    - retinopathy of prematurity
    - length of hospital stay

    Related to potential adverse events
    - birth weight
    - head circonference at birth
    - body length at birth
    - early onset sepsis
    Liés à la sévérité de la MMH
    - FiO2 maximale durant les premières 48h de vie
    - Pression moyenne maximale de ventilation pendant les premières 48h de vie
    - Durée de la ventilation mécanique et de ventilation non invasive
    - Utilisation et durée de l'oxygénothérapie
    - Besoin d'une ventilation et/ou d'une oxygénothérapie après 36 semaines d'âge gestationnel corrigé

    Liés à l'impact de la bétaméthasone sur les autres complications de la prématurité
    - décès neonatal
    - admission en unité de réanimation néonatale
    - utilisation d'un support hémodynamique par inotropes
    - pneumothorax
    - persistance du canal artériel traité médicalement ou chirurgicalement
    - entérocolite ulcéronécrosante de grade > II
    - hémorragie intra-ventriculaire et son grade
    - leucomalacie périventriculaire
    - utilisation de corticoïdes en postnatal
    - rétinopathie du prématuré traitée
    - durée totale d'hospitalisation avant sortie à domicile

    Liés à de potentiels effets indésirables
    - poids de naissance
    - périmètre céphalique à la naissance
    - taille à la naissance
    - infection néonatale précoce
    E.5.2.1Timepoint(s) of evaluation of this end point
    48 hours and 37 weeks of corrected gestational age.
    48 heures et 37 SA d'âge gestationnel 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 No
    E.6.5Efficacy No
    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.8.2.3.1Comparator description
    NaCl 0,9%
    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 concerned41
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 3142
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 Yes
    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 state3142
    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)
    No
    Aucun
    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 Decision2016-06-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-01-13
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