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    Summary
    EudraCT Number:2020-003194-22
    Sponsor's Protocol Code Number:APHP200009
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2020-09-07
    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 number2020-003194-22
    A.3Full title of the trial
    A RANDOMIZED PHASE III MULTICENTER TRIAL COMPARING THE EFFICACY AND SAFETY OF ANAKINRA VERSUS INTRAVENOUS IMMUNOGLOBULIN (IVIG) RETREATMENT, IN PATIENTS WITH KAWASAKI DISEASE WHO FAILED TO RESPOND TO INITIAL STANDARD IVIG TREATMENT (ANACOMP)
    Essai multicentrique randomisé de phase III comparant l'efficacité et la sécurité de l'anakinra au retraitement par immunoglobulines intraveineuses (IVIG), chez des patients atteints de la maladie de Kawasaki qui n'ont pas répondu au traitement initial standard par IVIG
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Essai multicentrique randomisé de phase III comparant l'efficacité et la sécurité de l'anakinra au retraitement par immunoglobulines intraveineuses (IVIG), chez des patients atteints de la maladie de Kawasaki qui n'ont pas répondu au traitement initial standard par IVIG
    A.3.2Name or abbreviated title of the trial where available
    ANACOMP
    A.4.1Sponsor's protocol code numberAPHP200009
    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 – Hôpitaux 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 supportministère de la santé
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAssistance Publique – Hôpitaux de Paris
    B.5.2Functional name of contact pointMalika Yahmi
    B.5.3 Address:
    B.5.3.1Street Address1 avenue Claude Vellefaux, hopital Saint-Louis
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number330144 84 17 45
    B.5.5Fax number330144 84 17 01
    B.5.6E-mailmalika.yahmi@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 KINERET 100 mg / 0.67 mL
    D.2.1.1.2Name of the Marketing Authorisation holderSwedish Orphan Biovitrum SARL
    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 nameKINERET
    D.3.4Pharmaceutical form Solution for infusion in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNANAKINRA
    D.3.9.1CAS number 143090-92-0
    D.3.9.4EV Substance CodeSUB05500MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 RoleComparator
    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 PRIVIGEN 100 mg / mL
    D.2.1.1.2Name of the Marketing Authorisation holderCSL Behring SA
    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 namePRIVIGEN
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeImmunoglobuline Humaine Normale
    D.3.9.3Other descriptive nameHUMAN NORMAL IMMUNOGLOBULIN
    D.3.9.4EV Substance CodeSUB14196MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Anakinra treatment is expected to reduce the early and long-term mortality of patients with Kawasaki Disease (KD), by a rapid and sustained effect on vascular inflammation.
    Le traitement par Anakinra pourrait réduire la mortalité précoce et à long terme des patients atteints de la maladie de Kawasaki (KD), par un effet rapide et durable sur l'inflammation vasculaire.
    E.1.1.1Medical condition in easily understood language
    Kawasaki disease, Coronary artery aneurysm, vasculitis, intravenous immunoglobulin
    Maladie de Kawasaki, anévrisme des artères coronaires, vascularite, immunoglobuline intraveineuse
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of Anakinra (IL-1R1 receptor antagonist) with 2nd IVIG infusion, in second line, on fever in patients with KD, who failed to respond to one infusion of IVIG(standard treatment).
    The main criterion-evaluating efficacy in both groups is: the patient must reach a body (axillary (+0.5°C), tympanic, oral) temperature <38˚C within 2 days after initiation of treatment (i.e. a binary outcome: success/failure).
    Comparer l'efficacité d'Anakinra (antagoniste des récepteurs IL-1R1) avec la 2ème perfusion d'IgIV, en deuxième ligne, sur la fièvre chez les patients atteints de KD, qui n'ont pas répondu à une seule perfusion d'IgIV (traitement standard).
    Le principal critère d'évaluation de l'efficacité dans les deux groupes est le suivant : le patient doit atteindre une température corporelle (axillaire (+0,5°C), tympanique, orale) <38˚C dans les 2 jours suivant le début du traitement (c'est-à-dire un résultat binaire : succès/échec).
    E.2.2Secondary objectives of the trial
    To compare Anakinra with IVIG retreatment in terms of:
    - Efficacy on fever at 72h
    - Efficacy on disease activity
    - Efficacy on KD symptoms
    - Efficacy on coronary lesions (e.g.: dilatation and aneurysm)
    - Efficacy on inflammation
    - Safety and tolerability
    Pour comparer l'Anakinra avec le retraitement à l'IVIG en termes de :
    - Efficacité sur la fièvre à 72h
    - Efficacité sur l'activité de la maladie
    - Efficacité sur les symptômes de la maladie de Kawasaki
    - Efficacité sur les lésions coronariennes (par exemple : dilatation et anévrisme)
    - Efficacité sur l'inflammation
    - Sécurité et tolérance
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Children, male and female, from 3 months to <18 years old
    - Patient ≥ 5 kg
    - Patient with KD according to the American Heart Association definition for complete or incomplete KD. (Fever ≥ 5 days (or at least 3 days if KD with AHA criteria since the third days of fever) and ≥ 4 of 5 main clinical signs: modification of the extremities, polymorphic exanthema, and bilateral bulbar not exudative conjunctivitis, erythema of the lips or oral cavity, and cervical lymph nodes usually unilateral > 1.5 cm in diameter.
    - Patients who failed to respond to the standard therapy of KD, e.g. Persistence or recrudescence of fever ≥ 38°C, 48 hours after the infusion of 2g/kg of IVIG. Patients may be screened 24h after the end of the first infusion if they remain febrile 24h after the end of the first infusion.
    - Patient, parents or legal guardian’s written informed consent is required
    - Patient with health insurance (SS or CMU)
    Efficient contraception for the duration of participation in the research for childbearing aged women
    - Enfants, garçon ou fille, don’t l’âge est entre 3 mois et 17.9 ans
    - Poids ≥ 5 kg
    - Patient atteint de KD selon la définition de l'American Heart Association pour une KD complète ou incomplète (fièvre ≥ 5 jours (ou au moins 3 jours si KD avec critères AHA depuis le troisième jour de fièvre) et ≥ 4 des 5 principaux signes cliniques : modification des extrémités, exanthème polymorphe, et conjonctivite bulbaire bilatérale non exsudative, érythème des lèvres ou de la cavité buccale, et ganglions cervicaux généralement unilatéraux > 1,5 cm de diamètre.
    - Patients qui n'ont pas répondu au traitement standard de la maladie de Kawasaki, par exemple persistance ou recrudescence de la fièvre ≥ 38°C, 48 heures après la perfusion de 2g/kg d'IVIG. Les patients peuvent être examinés 24 heures après la fin de la première perfusion s'ils restent fébriles 24 heures après la fin de la première perfusion.
    - Patient, parents ou tuteurs légaux ayant signé un consentement
    - Patient affilié à un régime de sécurité sociale ou CMU
    - Contraception efficace durant toute la participation à l’étude pour toutes les patientes en âge de procréer
    E.4Principal exclusion criteria
    - Preterm and neonates, pregnancy and breast feeding
    - Suspicion of another diagnosis
    - Patient with other concomitant bacterial, viral or fungal infection
    - Patient previously treated with steroids and/or another biotherapy
    - Patient with increased risk of TB infection
    - Recent tuberculosis infection or with active TB
    - Patient with any type of immunodeficiency or cancer
    - Patients with severe renal impairment (CLcr < 30 ml/minute)
    - Patients with hepatic insufficiency
    - Patients with neutropenia (ANC<1.5 x109/l)
    - Patients included in another interventional protocol
    Patient under the following treatments:
    - Preventive Antipyretics (paracetamol, NSAIDs other than aspirin 30-50mg/kg given for purpose of KD inflammation)
    - Immunosuppressive medications given in a period less than twice of their half-life prior the patient receives the study medication (systemic steroids, cyclosporine, tacrolimus, azathioprine, cyclophosphamide, interferon, mycophenolate, other anti-IL-1, anti IL-6, anti CD20 and anti TNF), plasmapheresis)
    - Hypersensitivity to anakinra or excipients (citric acid, sodium chloride, disodium EDTA, polysorbate 80, sodium hydroxide, in water for injection)
    - Hypersensitivity to IV Ig, or excipients (L-proline and water for injection), hypersensitivity to human normal immunoglobulin, in particular if the patient have anti-IgA antibodies
    - Patients with type I or II hyperprolinemia
    - Live vaccines within 1 month prior to enrollment
    -Hypersensitivity to anakinra or to immunoglobulins or to excipients of Kineret® or Privigen® or to E.coli proteins
    - Contraindication for administration of anakinra or IVIG listed in SmPC of Kineret® and Privigen®
    - Prématurés et nouveaux-nés, grossesse en cours, allaitement en cours
    - Suspicion d’un autre diagnostic
    - Patient présentant une infection bactérienne, virale ou fongique concomitante
    - Patient traité préalablement par steroids et/ou une autre biothérapie
    - Patient avec un risque accru d’infection à la Tuberculose
    - Infection à la Tuberculose récente ou en cours
    - Patient présentant une immunodéficience ou un cancer
    - Patient présentant une insuffisance rénale grave (CLcr < 30 ml/minute)
    - Patient présentant une insuffisance hépatique
    - Patient présentant une neutropénie (ANC<1.5 x109/l)
    - Patient inclus dans un autre protocole interventionnel
    Patient avec les traitements suivants:
    - Antipyrétiques préventifs (paracetamol, NSAID autre que l’aspirine 30-50mg/kg donnés pour l’inflammation dû à la KD)
    - Médicaments immunosuppresseurs administrés dans une période inférieure à deux fois leur demi-vie avant que le patient ne reçoive le médicament à l'étude (stéroïdes systémiques, cyclosporine, tacrolimus, azathioprine, cyclophosphamide, interféron, mycophénolate, autres anti-IL-1, anti IL-6, anti CD20 et anti TNF), plasmaphérèse)
    - Hypersensibilité à l'anakinra ou aux excipients (acide citrique, chlorure de sodium, EDTA disodique, polysorbate 80, hydroxyde de sodium, dans l'eau pour injection)
    - Hypersensibilité aux Ig IV, ou aux excipients (L-proline et eau pour injection), hypersensibilité aux immunoglobulines humaines normales, en particulier si le patient a des anticorps anti-IgA
    - Patient atteint d'hyperprolinémie de type I ou II
    - Vaccins vivants 1 mois avant l’inclusion
    - Hypersensibilité à l'anakinra ou aux immunoglobulines ou aux excipients de Kineret® ou Privigen® ou aux protéines de E.coli
    - Contre-indication pour l'administration d'anakinra ou d'IVIG figurant dans le SmPC de Kineret® et Privigen

    E.5 End points
    E.5.1Primary end point(s)
    The main criterion-evaluating efficacy in both groups is: the patient must reach a body (axillary (+0.5°C), tympanic, oral) temperature <38˚C within 2 days after initiation of treatment (i.e. a binary outcome: success/failure).
    Le principal critère d'évaluation de l'efficacité dans les deux groupes est le suivant : le patient doit atteindre une température corporelle (axillaire (+0,5°C), tympanique, orale) <38˚C dans les 2 jours suivant le début du traitement (c'est-à-dire un résultat binaire : succès/échec).
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 days after initiation of treatment
    2 jours suivant le début du traitement
    E.5.2Secondary end point(s)
    To compare Anakinra with IVIG retreatment in terms of:
    - Temperature <38˚C within 3 days (72h) after initiation of treatment
    - Decrease of the CRP values from baseline to day 30(CRP<6 mg/L at day 30)
    - Reduction in physician assessment of disease activity, on a 10 points scale, of at least to 50% between baseline and day 14.
    - Reduction in patient’s parent’s assessment of disease activity, on a 10 points scale, of to at least 50% between baseline and day 14.
    - Resolution of coronary abnormalities; i.e worst Z score <2.5, by echocardiogram if present at day 45.
    - Adverse events: pain/redness at injection site, bacterial infection hepatitis, macrophage activation syndrome, severe neutropenia,
    - Monitoring of adverse events
    o Physical examination: Complete clinical exam will be performed at each visit to detect symptoms of KD (rash, cervical nodes, mucous lesions, extremities, GI, pulmonary, CV, neurologic and muscular/joint evaluation) and possible associated morbidity: e.g. concomitant infection
    o Local tolerability of injections: will be evaluated by physician from V2 to V8: pain, redness, swelling, induration, itching, haemorrhage, (and quoted from none, mild, moderate, severe)
    o Vital signs and body measurements: at each visit: V1 to V9. The body temperature will be measured daily until d30. Parents will receive a follow-up booklet..
    o Laboratory evaluations: hematologic, hepatic and renal assessment will be followed
    Pour comparer l'Anakinra avec le retraitement à l'IVIG en termes de :
    - Température <38˚C dans les 3 jours (72h) suivant le début du traitement
    - Diminution de la CRP de l’inclusion au jour 30 (CRP<6 mg/L au jour 30)
    - Réduction de l'évaluation de l'activité de la maladie par les médecins, sur une échelle de 10 points, d'au moins 50 % entre l’inclusion et le 14e jour.
    - Réduction de l'évaluation de l'activité de la maladie par les parents du patient, sur une échelle de 10 points, d'au moins 50 % entre l’inclusion et le 14e jour.
    - Résolution des anomalies coronariennes, c'est-à-dire le pire score Z < 2,5, par échocardiographie si elles sont présentes au jour 45.
    - Effets indésirables : douleur/rougeur au point d'injection, infection bactérienne, hépatite, syndrome d'activation des macrophages, neutropénie sévère,
    - Surveillance des événements indésirables
    o Examen physique : Un examen clinique complet sera effectué à chaque visite pour détecter les symptômes de la maladie de Kawasaki (éruption cutanée, ganglions cervicaux, lésions muqueuses, extrémités, GI, pulmonaire, CV, évaluation neurologique et musculaire/articulaire) et la morbidité éventuelle associée : par exemple, infection concomitante
    o Tolérance locale des injections : sera évaluée par le médecin de V2 à V8 : douleur, rougeur, gonflement, induration, démangeaison, hémorragie, (et citée parmi aucune, légère, modérée, sévère)
    o Signes vitaux et mesures corporelles : à chaque visite : V1 à V9. La température corporelle sera mesurée quotidiennement jusqu'à J30. Les parents recevront un livret de suivi.
    o Évaluations de laboratoire : les évaluations hématologiques, hépatiques et rénales seront suivies
    E.5.2.1Timepoint(s) of evaluation of this end point
    days 3 (72h) after initiation of treatment, day 14, day 30, day 45, Day 60
    jour 3 (72h), jour 14, jour 30, jour 60
    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 Yes
    E.8.1.3Single blind No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Immunoglobulines intraveineuses (IVIG), de préférence la spécialité PRIVIGEN®
    Intravenous immunoglobulin (IVIG), preferably the specialty PRIVIGEN®
    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 concerned13
    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
    dernière visite
    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 months2
    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.1.1Number of subjects for this age range: 84
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 15
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 15
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 54
    F.1.2Adults (18-64 years) No
    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 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
    The consent is given by the legal representative
    Le consentement est donné par le représentant légal
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state84
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 84
    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 Decision2020-12-02
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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