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    Summary
    EudraCT Number:2008-005077-35
    Sponsor's Protocol Code Number:P080102
    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:2008-08-07
    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 number2008-005077-35
    A.3Full title of the trial
    Réponse au stress inflammatoire et traitement par hydroxyurée dans la drépanocytose
    A.4.1Sponsor's protocol code numberP080102
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Hydréa
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Meyers Squibb
    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 nameHydréa
    D.3.4Pharmaceutical form Capsule*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNHydroxyurée
    D.3.9.3Other descriptive nameHydroxycarbamide
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Le protocole de recherche translationnelle prévoit de comparer 3 groupes de patients drépanocytaires et un groupe témoin.
    Cette étude a pour but de comparer les marqueurs plasmatiques de l'inflammation de 20 enfants drépanocytaires (âgés de plus de 3 ans) traités par HYDREAR, 20 enfants non traités (âgés de plus de 3 ans) avec des crises fréquentes, 20 enfants non traités (âgés de plus de 5 ans) asymptomatiques et 20 sujets non drépanocytaires (enfants ou adultes).
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level PT
    E.1.2Classification code 10051835
    E.1.2Term Drepanocytosis
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Etudier chez des patients drépanocytaires, traités ou non par l'HU, le niveau de l'état inflammatoire à l'état basal par la mesure d'une gamme étendue de marqueurs d'inflammation, incluant notamment ceux dont l'expression est sus régulée par l'HU in vitro et d'apprécier en regard le niveau de la réponse naturelle en mesurant l'état d'activation de l'axe hypothalamus-hypophyse-corticosurrénale.
    E.2.2Secondary objectives of the trial
    déterminer l'existence ou l'absence de corrélation entre ces paramètres et le type d'expression clinique de la maladie (patients à symptomatologie vaso-occlusive sévère versus patients non symptomatiques).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Enfant drépanocytaire homozygote (SS) âgé de plus de 3 ans, dont les parents sont originaires d'Afrique subsaharienne, à l'état basal c'est-à-dire : à distance d'un épisode infectieux, vaso-occlusif ou anémique aigu (dernier épisode infectieux ou vaso-occlusif datant de plus de 4 semaines avant le prélèvement ou survenant plus de 2 semaines après, dernière transfusion datant de plus de 4 mois)

    -Appartenant à l'une des catégories ci-dessous :
    ¢Patients traités depuis plus de 3 mois par HU-HYDREAR pour une symptomatologie vaso-occlusive gravissime (> 3 hospitalisations / an), avec des critères d'efficacité clinique : Groupe I
    ¢Patients non traités par HU, avec des crises vaso-occlusives invalidantes, prédominantes (> 3 hospitalisations / an) : Groupe II
    ¢Patients non traités, avec une maladie drépanocytaire asymptomatique (âge > 5 ans) : Groupe III
    -Patients ne prenant pas d'autres médicaments que l'oracilline, la spéciafoldine, l'HU ou une supplémentation martiale le jour du prélèvement.
    -Patients dont les titulaires de l'autorité parentale ont signé un consentement
    -Patients dont les titulaires de l'autorité parentale sont affiliés à un régime de sécurité sociale ou CMU

    -Témoins : Fratries normales (AA) ou porteurs sains du trait drépanocytaire (AS), parents AS ; en bonne santé apparente, ne prenant pas de médicaments au moment du prélèvement, et après consentement éclairé dont les titulaires de l'autorité parentale ont signé un consentement et sont affiliés à un régime de sécurité sociale ou CMU.
    E.4Principal exclusion criteria
    - Enfant en période aiguë de la maladie (cf. critères d'inclusion)
    - Refus parental ou de l'enfant en âge de l'exprimer
    - Prise médicamenteuse autre que l'oracilline, la spéciafoldine, l'HU ou une supplémentation martiale
    - Témoin malade
    - Prise médicamenteuse par le témoin.
    E.5 End points
    E.5.1Primary end point(s)
    Critère principal d'évaluation
    Dosage des marqueurs d'inflammation plasmatiques (RANTES, IL-6, IL-8, MCP-1, IL-1A, IL-1B, ET-1, IL-4, IL-10, TNF , IFN ), des hormones de l'axe hypophyso-surrénalien (cortisol, ACTH) et des peptides hypothalamiques (AVP, CRH)

    Critères secondaires d'évaluation:
    - Données cliniques (âge, sexe du patient et de son parent ou fratrie, fréquence des crises douloureuses nécessitant une hospitalisation, mesurée / an dans les 3 années précédant l'étude, fréquence et cause des épisodes anémiques aigus, existence ou non d'une hépatosplénomégalie)
    - Paramètres hématologiques à l'état basal (Hb, réticulocytes, VGM, plaquettes, leucocytes, PN et monocytes, lymphocytes, érythroblastes, statut martial)
    - Dosage d'HbF
    - Dosage des marqueurs de l'"acute phase" : CRP et orosomucoïde
    - Concentrations plasmatiques de l'HU juste avant la prise d'HU (concentration résiduelle) et à H2 après la prise.

    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 No
    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 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned3
    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 Information not present in EudraCT
    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
    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 months6
    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 Yes
    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.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) Yes
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception Yes
    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 state100
    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 Decision2008-09-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-09-10
    P. End of Trial
    P.End of Trial StatusOngoing
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