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    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2017-004866-86
    Sponsor's Protocol Code Number:P160944J
    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:2020-12-03
    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 number2017-004866-86
    A.3Full title of the trial
    Evaluation of the benefit of adjuvant treatment with hydroxychloroquine to usual medical care for uncomplicated term pregnancy in patients with primary obstetrical antiphospholipid syndrome: randomized, double-blind, placebo-controlled phase II study. HYDROSAPL study
    Evaluation du bénéfice d’un traitement adjuvant par hydroxychloroquine à la prise en charge médicale habituelle pour l’obtention d’une grossesse à terme non-compliquée en cas de syndrome des antiphospholipides obstétrical primaire: Etude de phase II multicentrique randomisée en double aveugle versus placebo. Etude HYDROSAPL
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the benefit of using hydroxychloroquine for uncomplicated term pregnancy in patients with primary obstetric antiphospholipid syndrome
    Evaluation du bénéfice de l'utilisation d'hydroxychloroquine pour l'obtention d'une grossesse à terme non-compliquée en cas de syndrome des antiphospholipides obstétrical primaire
    A.3.2Name or abbreviated title of the trial where available
    HYDROSAPL
    A.4.1Sponsor's protocol code numberP160944J
    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 (ministère de la Santé - France)
    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 pointElodie SOLER -DRCI 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 Plaquenil
    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.3.1Product namePlaquenil
    D.3.4Pharmaceutical form Buccal tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSulfate d'hydroxychloroquine
    D.3.9.3Other descriptive nameSulfate d'hydroxychloroquine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 placeboBuccal tablet
    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
    Primary obstetrical antiphospholipid syndrome
    Syndrome des antiphospholipides (SAPL) obstétrical primaire
    E.1.1.1Medical condition in easily understood language
    Primary Obstetric Antiphospholipid Syndrome
    Syndrome des antiphospholipides (SAPL) obstétrical primaire
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10002817
    E.1.2Term Antiphospholipid syndrome
    E.1.2System Organ Class 10005329 - Blood and lymphatic system 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 evaluate the benefit of adding or not adding hydroxychloroquine to the usual medical management in case of obstetrical SAPL in obtaining an uncomplicated pregnancy over time with a eutrophic child: (1) living child; (2) without maternal complication (pre-eclampsia, HELLP, thrombosis); (3) without fetal complications (IUGR); (4) without complications or neonatal morbidity on day 7 (hypotrophy, infectious, prematurity); (5) term> 37 WA.
    Evaluer le bénéfice de l’ajout ou non d‘hydroxychloroquine à la prise en charge médicale habituelle en cas de SAPL obstétrical dans l’obtention d’une grossesse non compliquée à terme avec un enfant eutrophe : (1) enfant vivant ; (2) sans complication maternelle (pré- éclampsie, HELLP, thrombose) ; (3) sans complication fœtale (RCIU) ; (4) sans complication ou morbidité néonatale à J7 (hypotrophie, infectieuses, prématurité) ; (5) terme > 37 SA.
    E.2.2Secondary objectives of the trial
    - Evaluation of the efficacy of a hydroxychloroquine treatment during pregnancy on the percentage of maternal or fetal complications (prematurity, preeclampsia, IUGR, HELPP syndrome, retroplacental hematoma, thrombosis)
    - Evaluation of the efficacy of hydroxychloroquine treatment on neonatal characteristics (weight and / or height and / or PC <5th and 10th percentile, APGAR 5 minutes ≤ 7)
    - To study the influence of the blood concentration of hydroxychloroquine on the risk of maternal, fetal complications during pregnancy
    - To study the influence of hydroxychloroquine treatment on the evolution of complement levels during pregnancy
    - To study the tolerance of hydroxychloroquine treatment during pregnancy.
    - To study the influence of a hydroxychloroquine treatment on the modification of the immune populations T, B, NK and cytokines.
    - Study compliance with hydroxychloroquine treatment during pregnancy
    - Evaluation de l’efficacité d’un traitement par hydroxychloroquine pendant la grossesse sur le pourcentage de complications maternelles ou fœtales (prématurité, prééclampsie, RCIU, HELPP syndrome, hématome retroplacentaire, thromboses)
    - Evaluation de l’efficacité d’un traitement par hydroxychloroquine sur les caractéristiques néonatales (poids et/ou taille et/ou PC <5e et 10e percentile, APGAR 5 minutes ≤ 7)
    - Etudier l’influence de la concentration sanguine d’hydroxychloroquine sur le risque de complications maternelles, fœtales au cours de la grossesse
    - Etudier l’influence d’un traitement par hydroxychloroquine sur l’évolution du taux du complément pendant la grossesse
    - Etudier la tolérance d’un traitement par hydroxychloroquine pendant la grossesse
    - Etudier l’influence d’un traitement par hydroxychloroquine sur la modification des populations immunitaires T, B, NK et des cytokines
    - Etudier la compliance au traitement par hydroxychloroquine au cours de la grossesse
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Woman aged ≥ to 18 years
    - Obstetric SAPL (modified Sapporo criteria = Sydney criteria) defined as fetal death ≥10 weeks of amenorrhea without further explanation; and / or preeclampsia (or HELLP syndrome) and / or prematurity <34SA related to placental insufficiency with or without thrombotic SAPL
    - Spontaneous pregnancy in progress before 14 SA
    - Ability to give informed, written, dated and signed consent prior to the commencement of any trial-related procedure and to comply with protocol recommendations
    - Femme d’âge ≥ à 18 ans
    - SAPL obstétrical (critères de Sapporo modifiés = critères de Sydney) défini par une mort fœtale ≥10 semaines d’aménorrhée sans d’autres explications ; et/ou une prééclampsie (ou un HELLP syndrome) et/ou une prématurité <34SA en rapport avec une insuffisance placentaire avec ou sans SAPL thrombotique
    - Grossesse spontanée en cours avant 14 SA
    - Capacité à donner son consentement éclairé, écrit, daté et signé avant le début de toute procédure liée à l’essai et de se conformer aux recommandations du protocole
    E.4Principal exclusion criteria
    - Other SAPL subgroups: early isolated miscarriage <10 SA
    - Minor patient
    - Not affiliated to a social security scheme
    - Contraindication to hydroxychloroquine
    o retinopathies,
    o hypersensitivity to chloroquine or hydroxychloroquine or to any of the other ingredients of this medication, including lactose
    - Systemic systemic lupus, associated Sjogren syndrome
    - Hydroxychloroquine treatment in progress
    - Patient under guardianship or curatorship
    - Patient deprived of liberty
    - Autres sous-groupes de SAPL : fausses couches isolées précoces <10 SA
    - Patiente mineure
    - Non affiliée à un régime de sécurité sociale
    - Contre-indication à l’hydroxychloroquine
    o rétinopathies,
    o hypersensibilité à la chloroquine ou à l'hydroxychloroquine ou à l'un des autres constituants de ce médicament et notamment au lactose
    - Lupus systémique associé, syndrome de Sjogren associés
    - Traitement par hydroxychloroquine en cours
    - Patiente sous tutelle ou curatelle
    - Patiente privé de liberté
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of uncomplicated term pregnancies with a eutrophic child (= a live birth with no maternal, fetal or neonatal complications)
    Pourcentage de grossesses à terme non compliquées avec un enfant eutrophe (=une naissance vivante à terme sans complications maternelles, foetales ou néonatales)
    E.5.1.1Timepoint(s) of evaluation of this end point
    At delivery
    A l'accouchement
    E.5.2Secondary end point(s)
    - Percentage of complications (prematurity, preeclampsia, IUGR, HELPP syndrome, thrombosis, retroplacental hematoma) during pregnancy
    - Neonatal characteristics (weight and / or height and / or PC <10percentile, APGAR 1/5 minutes <or equal 7)
    - Percentage of SAPL complications according to the rate of hydroxychloroquine
    - Evolution of the level of antiphospholipid antibodies
    - Evolution of the complement level during pregnancy
    - Percentage of maternal, fetal and neonatal side effects related to hydroxychloroquine
    - Modification of the frequencies of the immune populations T, B, NK and cytokine levels under hydroxychloroquine (ancillary study)
    - Number of hydroxychloroquine tablets taken (Patient Log)
    - Pourcentage de complications (prématurité, prééclampsie, RCIU, HELPP syndrome, thromboses, hématome retroplacentaire) au cours de la grossesse
    - Caractéristiques néonatales (poids et/ou taille et/ou PC <10e percentile, APGAR 1/5 minutes < ou égal 7)
    - Pourcentage de complications au cours de la grossesse selon le taux de l'hydroxychloroquine
    - Evolution du taux des anticorps antiphospholipides
    - Evolution du taux du complément pendant la grossesse
    - Pourcentage d'effets secondaires maternels, foetaux et néonataux en rapport avec l'hydroxychloroquine
    - Modification des fréquences des populations immunitaires T, B, NK et des taux de cytokines sous hydroxychloroquine (étude ancillaire)
    - Nombre de comprimés de hydroxychloroquine pris (Carnet patient)
    E.5.2.1Timepoint(s) of evaluation of this end point
    During pregnency and at delivery
    Pendant la grossesse et à l'accouchement
    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 No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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.8.2.4Number 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 concerned34
    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 years4
    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: 110
    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 No
    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 state110
    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
    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 Decision2020-01-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-07
    P. End of Trial
    P.End of Trial StatusOngoing
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