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    Summary
    EudraCT Number:2021-002219-69
    Sponsor's Protocol Code Number:CHUBX2019/49
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-05-28
    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 number2021-002219-69
    A.3Full title of the trial
    Long-term iron chelation in the prevention of secondary degeneration after cerebral infarction
    Chélation du fer au long cours dans la prévention de la dégénérescence secondaire après infarctus cérébral


    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-term iron chelation in the prevention of secondary degeneration after cerebral infarction
    Chélation du fer au long cours dans la prévention de la dégénérescence secondaire après infarctus cérébral
    A.4.1Sponsor's protocol code numberCHUBX2019/49
    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 Bordeaux
    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 supportProgramme Hospitalier de Recherche Clinique Interrégional (PHRC I) 2019
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Bordeaux
    B.5.2Functional name of contact pointResponsable d'Etudes Cliniques
    B.5.3 Address:
    B.5.3.1Street AddressDirection de la recherche clinique et de l’innovation
    B.5.3.2Town/ cityTalence
    B.5.3.3Post code33 404
    B.5.3.4CountryFrance
    B.5.4Telephone number0557820317
    B.5.5Fax number0556794926
    B.5.6E-mailleila.boukami@chu-bordeaux.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 Ferriprox 500 mg comprimés pelliculés
    D.2.1.1.2Name of the Marketing Authorisation holderChiesi Farmaceutici S.p.A.Via Palermo 26/A43122 Parma Italie
    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 Information not present in EudraCT
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFerriprox 500 mg comprimés pelliculés
    D.3.2Product code Ferriprox 500 mg comprimés pelliculés
    D.3.4Pharmaceutical form 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 INNDEFERIPRONE
    D.3.9.1CAS number 30652-11-0
    D.3.9.4EV Substance CodeSUB06941MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    Stroke
    E.1.1.1Medical condition in easily understood language
    Stroke
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare, in patients with proximal occlusion of the sylvian artery, the effect of prolonged treatment (6 months) with defereriprone (Ferriprox®) given daily at a low dose (30mg/Kg/d) from J3-J5, on the evolution of the iron accumulation (95th percentile of R2* values) between an initial MRI (J5) and at 6 months within the homolateral black substance and initially spared by the infarction, compared to the values measured without treatment in our previous work.
    Comparer, chez les patients victimes d’un infarctus par occlusion proximale de l’artère sylvienne, l’effet d’un traitement prolongé (6mois) par défériprone (Ferriprox®) administré quotidiennement à faible dose (30mg/Kg/j) à partir de J3-J5, sur l’évolution de la charge en fer entre une IRM initiale (<J5) et à 6 mois au sein de la substance noire homolatérale et initialement épargnée par l’infarctus, par rapport aux valeurs mesurées sans traitement dans nos travaux antérieurs.
    E.2.2Secondary objectives of the trial
    To compare the effect of prolonged treatment (6 months) with defereriprone (Ferriprox®) given daily at low dose (30mg/Kg/d) from J3-J5, on :

    - evolution of iron accumulation (95th percentile of R2* values) between an initial MRI (J5) and 6 months within the homolateral thalamus and initially spared by the infarction, compared to the values measured without treatment in our previous work.

    - clinical performance measured at 6 months (and 3 months) between patients treated with defereriprone and untreated patients (effect difference and confidence interval of difference).

    To compare voxel to voxel the evolution of the iron load (95th percentile of R2* values and QSM measurements) between an initial MRI (J5) and at 6 months after a sylvian infarction within the black substance, thalamus and the whole brain, between patients treated with defereriprone (experimental group) and untreated patients (control group).
    Comparer l’effet d’un traitement prolongé (6mois) par défériprone (Ferriprox®) administré quotidiennement à faible dose (30mg/Kg/j) à partir de J3-J5, sur l’évolution de la charge en fer (95ème percentile des valeurs de R2*) entre une IRM initiale (<J5) et à 6 mois :

    - au sein du thalamus homolatéral et initialement épargné par l’infarctus, par rapport aux valeurs mesurées sans traitement dans nos travaux antérieurs.

    - sur les performances cliniques mesurées à 6 mois (et à 3 mois) entre les patients traités par défériprone et les patients non traités (différence d’effet et intervalle de confiance de la différence).

    Comparer voxel à voxel l’évolution de la charge en fer (95ème percentile des valeurs de R2* et mesures de QSM) entre une IRM initiale (<J5) et à 6 mois après un infarctus sylvien au sein de la substance noire, du thalamus et de l’ensemble du cerveau, entre les patients traités par défériprone (groupe expérimental) et les patients non traités (groupe contrôle).
    E.2.3Trial contains a sub-study No
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    - Patient older than 18 years old.
    - Covered by a social insurance
    - With a stroke involving the deep territory of the middle cerebral artery (including at least half of the volume of the striatum) due to occlusion of the carotid artery or of proximal M1 or M2 segments. The artery can be occluded when the patient is admitted at the acute phase or already recanalized as soon as the striatum is involved.
    - Absolute neutrophil count ≥1.5 x109/L.
    - For women of childbearing potential, negative β HCG test and effective contraception.
    - Written informed consent dated and signed prior to the beginning of any procedures related to the clinical trial. Patients unable to give their personal consent (severe aphasia, impaired understanding or attention induced by the infarction) may be included with the consent by a trusted person provided in article L. 1111-6, by the family or by a person who has a close and stable relationship with the person concerned. The person concerned is informed as soon as possible and his consent is sought during visit at 3 month or 6 month if he regains his capacity to consent. These patients may be included because the treatment may be provided by the caregiver, or a home nurse for patients alone or for whom the caregiver is unable to follow the treatment. Most severe patients, in rehabilitation structure will have support for taking treatment and monitoring it
    E.3Principal inclusion criteria
    - Patient older than 18 years old.
    - Covered by a social insurance
    - With a stroke involving the deep territory of the middle cerebral artery (including at least half of the volume of the striatum) due to occlusion of the carotid artery or of proximal M1 or M2 segments. The artery can be occluded when the patient is admitted at the acute phase or already recanalized as soon as the striatum is involved.
    - Absolute neutrophil count ≥1.5 x109/L.
    - For women of childbearing potential, negative β HCG test and effective contraception.
    - Written informed consent dated and signed prior to the beginning of any procedures related to the clinical trial. Patients unable to give their personal consent (severe aphasia, impaired understanding or attention induced by the infarction) may be included with the consent by a trusted person provided in article L. 1111-6, by the family or by a person who has a close and stable relationship with the person concerned. The person concerned is informed as soon as possible and his consent is sought during visit at 3 month or 6 month if he regains his capacity to consent. These patients may be included because the treatment may be provided by the caregiver, or a home nurse for patients alone or for whom the caregiver is unable to follow the treatment. Most severe patients, in rehabilitation structure will have support for taking treatment and monitoring it
    1. Patient de plus de 18 ans sans limite d’âge maximum.
    2. Affilié ou bénéficiaire d’un régime de sécurité sociale.
    3. Victime d’un infarctus cérébral concernant le territoire profond (atteinte d’au moins la moitié du striatum selon l’investigateur) de l’artère cérébrale moyenne (sylvien) en rapport avec une occlusion du T carotidien ou de la sylvienne dans sa portion M1 ou M2. L’artère peut être occluse au moment de la prise en charge ou déjà recanalisée mais se traduire par un infarctus profond touchant le striatum.
    5. Nombre de polynucléaires neutrophiles ≥1.5 x109/L.
    6. Pour les patientes en capacité de procréer, test de grossesse plasmatique négatif et utilisation d’une méthode de contraception efficace.
    7. Consentement libre, éclairé et écrit signé par le participant et le médecin investigateur (au plus tard le jour de l’inclusion et avant tout examen nécessité par la recherche). Les patients incapables de donner personnellement leur consentement (aphasie sévère, troubles de la compréhension ou de l’attention induits par l’infarctus) pourront être inclus via l’obtention du consentement par une personne de confiance prévue à l'article L. 1111-6, à défaut de celle-ci, par la famille, ou, à défaut, par une personne entretenant avec l'intéressé des liens étroits et stables. L'intéressé est informé dès que possible et son consentement est recherché lors de la visite à 3 mois ou 6 mois s'il retrouve sa capacité à consentir. Ces patients pourront être inclus car le traitement pourra être donné par l’aidant, ou une infirmière à domicile pour les patients seuls ou pour lesquels l’aidant n’est pas en capacité de suivre les traitements. Les patients les plus sévères qui seront en structure de rééducation auront un accompagnement pour la prise du traitement et sa surveillance.
    E.4Principal exclusion criteria
    - Contraindication to MRI.
    - Pregnant or breast feeding women.
    - Inability to swallow correctly (required for oral treatment).
    - History of symptomatic cerebral infarct or hemorrhage.
    - Pre-stroke modified Rankin Scale [mRS] score>2).
    - History of severe cognitive impairment (dementia).
    - History of recent (within the past 6 months) and evolving psychiatric disorders matching to axis 1 of the DSM-IV criteria.
    - History of stroke directly involving substantia nigra or thalamus.
    - Microbleed, or past hematoma involving substantia nigra; past hematoma involving thalamus.
    - PH1 or PH2 hemorrhagic transformation.
    - Hypersensitivity to Deferiprone or any of the excipients.
    - Patients with agranulocytosis or with a history of agranulocytosis.
    - Patients with history of relapsing neutropenia.
    - Patient with immunosuppression condition.
    - Due to the risk of agranulocytosis caused by Deferiprone and the unknown mechanism by which this agranulocytosis is induced, combining Deferiprone with other medicinal products known to cause agranulocytosis will not be allowed. Such medicinal products include clozapine as well as some NSAIDs (e.g. Phenylbutazone or Metamizole), antithyroid agents, sulfonamide antibiotics or metothrexate.
    - Patients with anaemia (regardless of latter aetiology) or a history of another haematological disease.
    - Participation in another drug study (Investigational medical product) within 1 month prior to inclusion in the study and within 1 month after the final evaluation.
    - Kidney or liver failure.
    - Patient in an emergency situation
    - Patient under permanent guardianship.
    - Patient subject to a safeguard measure of justice.
    - Contre-indication à l’IRM.
    - Femme enceinte ou allaitant.
    - Troubles de la déglutition empêchant la prise du traitement per os.
    - Antécédent d’infarctus cérébral ou d’hémorragie symptomatique.
    - Score de Rankin modifié pré-infarctus >2).
    - Antécédent de troubles cognitifs sévères (démence).
    - Troubles psychiatriques actuels (au cours des 6 derniers mois) et évolutifs de l’axe 1 du DSM-IV.
    - Antécédent d’infarctus touchant de façon directe la substance noire ou le thalamus.
    - Micro-saignement ou séquelle d’hématome touchant la substance noire, ou séquelle d’hématome touchant le thalamus. La présence de micro-saignements (microbleed) dans le thalamus ne contre-indique pas l’inclusion car les voxels concernés pourront être exclus des masques lors de l’analyse (ce qui n’est pas le cas pour la substance noire qui est de taille beaucoup plus petite).
    - Remaniement hémorragique de type PH1 ou PH2 au sein de l’infarctus.
    - Hypersensibilité connue à la défériprone.
    - Agranulocytose ou antécédents d’agranulocytose.
    - Antécédents d’épisodes récurrents de neutropénie.
    - Patient immunodéprimé.
    - Prise de médicaments connus pour être associés avec une neutropénie ou susceptibles de provoquer une agranulocytose incluant la clozapine, certains AINS (phénylbutazone, métamizole), agents anti-thyroidiens, antibiotiques sulfamidés, méthotrexate.
    - Anémie (quel que soit l’étiologie) ou histoire de maladie hématologique.
    - Participation à une autre étude, autre qu’observationnelle, avec prise d’un autre traitement en cours d’évaluation dans les 30 jours (ou les 5 demi-vies) précédents la première prise de défériprone et jusqu’à 30 jours après la fin de la recherche.
    - Insuffisance rénale avec débit de filtration glomérulaire < 30 ml/min et/ou insuffisance hépatique ou fibrose hépatique.
    - Personne en situations d'urgence
    - Personnes privées de liberté par une décision judiciaire ou administrative
    - Personne faisant l'objet d'une mesure de sauvegarde de justice (tutelle, curatelle). Si le patient est mis sous tutelle ou curatelle au cours du suivi (après avoir été inclus), l’autorisation de maintenir le patient dans l’étude devra être obtenue auprès du tuteur.
    E.5 End points
    E.5.1Primary end point(s)
    Variation of iron as measured by R2* (95th percentile) between the baseline MRI (performed before day 5) and the 6 month MRI, within the substantia nigra ipsilateral to stroke in the group of patients randomized to receive Deferiprone.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Between baseline MRI and 6 month MRI
    E.5.2Secondary end point(s)
    1/ The variation of iron as measured by R2* (95th percentile) between the baseline MRI (performed before day 5) and the 6 month MRI, within the thalamus ipsilateral to stroke (whole thalamus and median nucleus) in the group of patients randomized to receive Deferiprone.

    2/ The variation of R2* and of values from quantitative susceptibility mapping (QSM) between the baseline MRI (performed before day 5) and the 6 month MRI with a voxel-by-voxel quantification in patients randomized to receive Deferiprone versus those who will not receive Deferiprone.

    3/ The clinical scores at 3 months and 6 months in patients randomized to receive Deferiprone and in patients from the control group: functional outcome assessed by the upper limb Fugl-Meyer scale, the Box and Block test and the modified Rankin scale (mRS); cognitive outcome assessed by the Montreal cognitive assessment (MoCA), and mood disorders assessed by the center for epidemiologic studies depression scale (CES-D) and the generalized anxiety disorder scale (GAD-7).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline
    3 months
    6 month
    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 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.1.7.1Other trial design description
    Control group
    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 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 concerned4
    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 years
    E.8.9.1In the Member State concerned months30
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    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 Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Severe aphasia, impaired understanding or attention induced by the infarction
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    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 Decision2021-07-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-22
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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