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    Summary
    EudraCT Number:2017-003999-31
    Sponsor's Protocol Code Number:RC15_0476
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-12-05
    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 number2017-003999-31
    A.3Full title of the trial
    Efficacité d’une Supplémentation anténatale maternelle en N-acétylcystéine dans les contextes de MAP (Menace d’Accouchement Prématuré) modérées ou sévères, sur la correction du déficit en glutathion du nouveau-né à la naissance
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacité d’une Supplémentation anténatale maternelle en N-acétylcystéine dans les contextes de MAP (Menace d’Accouchement Prématuré) modérées ou sévères, sur la correction du déficit en glutathion du nouveau-né à la naissance
    A.3.2Name or abbreviated title of the trial where available
    GSH MAP
    A.4.1Sponsor's protocol code numberRC15_0476
    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 de 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 supportCHU de Nantes
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Nantes
    B.5.2Functional name of contact pointDirection Recherche CHU de Nantes
    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 number0033253482835
    B.5.5Fax number0033253482836
    B.5.6E-mailsandrine.coudol@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 No
    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 nameNAC 1.5g/250ml
    D.3.2Product code PRD5572538
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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.IMP: 2
    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 No
    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 nameNAC 7.5g/500ml
    D.3.2Product code PRD5572687
    D.3.4Pharmaceutical form Infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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.IMP: 3
    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 No
    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 nameNAC 600mg cp
    D.3.2Product code PRD5572959
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 placeboInfusion
    D.8.4Route of administration of the placeboIntravenous bolus use (Noncurrent)
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInfusion
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Femmes en situation de Menace d'Accouchement Prématuré sévère ou modérée entre 24 et 34 Semaines d'Aménorrhée
    E.1.1.1Medical condition in easily understood language
    Femmes en situation de menace d'accouchement prématuré
    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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10014053
    E.1.2Term Early or threatened labour
    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
    Déterminer si une supplémentation en N-acétylcystéine (NAC) chez des femmes en situation de Menace d’Accouchement Prématuré (MAP) modérée ou sévère, permet de corriger le déficit en glutathion sanguin du fœtus à la naissance.
    E.2.2Secondary objectives of the trial
    Déterminer si la supplémentation orale en NAC, chez des femmes en MAP, retarde le terme d’accouchement, module le statut oxydatif de la dyade mère-enfant, de l’unité foeto-placentaire et du lait maternel pendant la période péripartum, augmente la vélocité de croissance ou le poids de naissance du nouveau-né, diminue les pathologies liées à la prématurité.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Femmes enceintes ≥ 18 ans
    - Diagnostiquées avec une MAP sévère ou modérée.
    - Présentant une grossesse mono-foetale
    - Et un terme de grossesse ≥24SA et <34SA au diagnostic
    - Consentement éclairé et écrit de la patiente.
    - Affiliation à un régime de sécurité sociale.
    E.4Principal exclusion criteria
    - Sujets de moins de 18 ans
    - Majeurs sous tutelle ou curatelle
    - Refus maternel et/ou Incapacité à comprendre les bénéfices et risques potentiels du protocole et à signer un formulaire de consentement éclairé.
    - Mères présentant :
    • Un IMC en début de grossesse inférieur à 18 ou supérieur à 40
    • Un diabète de type I, II
    • Des troubles épileptiques
    • Un antécédent d’asthme
    • Une pathologie hémorragique
    • Une insuffisance hépatique
    • Une infection maternelle (VIH, hépatite B et C) autre que chorioamniotite
    - Patientes en travail traitées au sulfate de magnésium
    - Grossesse multiple
    - Hypersensibilité/allergie connue à la N-acétylcystéine
    - Pathologie fœtale (tels que : anomalie du caryotype, malformation, retard de croissance intra-utérin < 10ème percentile)
    -Traitements récents ou concomitants d’antioxydants à hautes doses (suppléments vitaminiques, ….)
    - Pas d’affiliation à un régime de sécurité sociale.
    - Retrait de consentement
    E.5 End points
    E.5.1Primary end point(s)
    Concentration en glutathion dans le sang veineux de cordon à la naissance.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Jour de l'accouchement
    E.5.2Secondary end point(s)
    Critères d’évaluation secondaire pour la mère :
    - le nombre de jours et heures, entre l’initiation de la supplémentation en NAC et l’accouchement.
    - Concentrations plasmatiques et érythrocytaires de glutathion réduit (GSH) à l’inclusion et à l’accouchement
    - Concentrations placentaires en glutathion réduit (GSH) à l’accouchement
    - Concentrations de glutathion réduit (GSH) dans le lait maternel des femmes allaitantes à J7 post partum +/-24h pour les enfants hospitalisés
    - Profils acido-aminergiques (fréquence relative de chaque acide aminé, en particulier la cystéine et le glutathion) plasmatiques, érythrocytaires et placentaires aux différents temps de l’étude

    Critères d’évaluation secondaires pour le nouveau-né :
    - Données staturo-pondérales et le Zscore de Poids à la naissance, le delta de poids, de taille et de périmètre crânien entre la baseline et l’accouchement ; les variations du delta de Zscore de poids entre la baseline et l’accouchement.
    - Concentrations plasmatiques et érythrocytaires de glutathion réduit (GSH) en période néonatale (J1/J3/J5/J14 post partum) par rapport aux valeurs obtenues à l’accouchement dans le sang de cordon (reflet du statut fœtal).
    - Fréquence des principales pathologies néonatales en lien avec la prématurité : syndrome de détresse respiratoire SDR, entérocolite ulcéro-nécrosante ECUN, hémorragie intra-ventriculaire, HIV, rétinopathie, septicémie, dysplasie broncho-pulmonaire DBP,..) diagnostiquées durant l’hospitalisation.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Jour de l'accouchement, J7 post partum, J14 post partum
    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 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
    Etude de physiopathologie
    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 Yes
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    1 an après la sortie d'hospitalisation de la dernière patiente se prêtant à la recherche
    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 days
    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: 120
    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 state120
    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 Decision2018-03-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-12
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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