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    Summary
    EudraCT Number:2021-001834-20
    Sponsor's Protocol Code Number:APHP191105
    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:2021-12-10
    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 number2021-001834-20
    A.3Full title of the trial
    Randomized controlled trial testing the efficacy of hydroxychloroquine combined with low dose corticosteroid therapy in pulmonary sarcoidosis
    Essai randomisé contrôlé testant l’efficacité de l’hydroxychloroquine associée à une corticothérapie faible dose dans la sarcoïdose pulmonaire
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized controlled trial testing the efficacy of hydroxychloroquine combined with low dose corticosteroid therapy in pulmonary sarcoidosis
    Essai randomisé contrôlé testant l’efficacité de l’hydroxychloroquine associée à une corticothérapie faible dose dans la sarcoïdose pulmonaire
    A.3.2Name or abbreviated title of the trial where available
    QUIDOSE
    QUIDOSE
    A.4.1Sponsor's protocol code numberAPHP191105
    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
    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
    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
    B.5.2Functional name of contact pointDRCI - Hôpital Saint-Louis
    B.5.3 Address:
    B.5.3.1Street Address1 Avenue Claude Vellefaux
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number33144841726
    B.5.5Fax number33144841701
    B.5.6E-mailsabrina.williams@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 nameHydroxychloroquine
    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 INNHydroxychloroquine
    D.3.9.1CAS number 118-42-3
    D.3.9.4EV Substance CodeSUB08077MIG
    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.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 Prednisone
    D.2.1.1.2Name of the Marketing Authorisation holderARROW GENERIQUES
    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 namePrednisone
    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 INNPrednisone
    D.3.9.1CAS number 53-03-2
    D.3.9.3Other descriptive namePREDNISONE
    D.3.9.4EV Substance CodeSUB10020MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number5 to 20
    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.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 Yes
    D.2.1.1.1Trade name PREDNISONE
    D.2.1.1.2Name of the Marketing Authorisation holderARROW GENERIQUES
    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 namePrednisone
    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 INNPrednisone
    D.3.9.1CAS number 53-03-2
    D.3.9.3Other descriptive namePREDNISONE
    D.3.9.4EV Substance CodeSUB10020MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    mediastino-pulmonary sarcoidosis
    sarcoïdose médiastino-pulmonaire
    E.1.1.1Medical condition in easily understood language
    mediastino-pulmonary sarcoidosis
    sarcoïdose médiastino-pulmonaire
    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 10037430
    E.1.2Term Pulmonary sarcoidosis
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Demonstrate the non-inferiority of the combination of hydroxychloroquine and low dose corticosteroids versus medium dose corticosteroid therapy in improving respiratory function at 6 months.
    Démontrer la non infériorité de l’association hydroxychloroquine et faible dose de corticoïdes versus une corticothérapie moyenne dose sur l’amélioration de la fonction respiratoire à 6 mois.
    E.2.2Secondary objectives of the trial
    Demonstrate the superiority of the combination hydroxychloroquine and low dose corticosteroids versus medium dose corticosteroid therapy at 3, 6 months and 1 year on:
    • General quality of life
    • Respiratory quality of life
    • Fatigue
    • Adverse effects of treatment
    • Compliance with treatments

    Demonstrate the non-inferiority of the combination of hydroxychloroquine and low dose corticosteroids versus medium dose corticosteroid therapy at 3, 6 months and 1 year on:
    • Respiratory function using additional tools
    • Functional respiratory signs
    • The activity and flare-ups of thoracic and extra-thoracic sarcoidosis.
    Démontrer la supériorité de l’association hydroxychloroquine et faible dose de corticoïdes versus une corticothérapie moyenne dose à 3, 6 mois et 1 an sur :
    • La qualité de vie générale
    • La qualité de vie respiratoire
    • La fatigue
    • Les effets indésirables du traitement
    • L’observance des traitements

    Démontrer la non infériorité de l’association hydroxychloroquine et faible dose de corticoïdes versus une corticothérapie moyenne dose à 3, 6 mois et 1 an sur :
    • La fonction respiratoire à l’aide d’outils complémentaires
    • Les signes fonctionnels respiratoires
    • L’activité et poussées de la sarcoïdose thoracique et extra thoracique.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients ≥18 years and ≤80 years
    • Mediastino-pulmonary sarcoidosis meeting diagnostic criteria (ATS 2020 AJRCCM) (13).
    • Patients with radiographic stage II / III and FVC <80% and respiratory symptom (s).
    • French speaking patients.
    • Effective contraception in women of childbearing age
    • Informed and signed consent.
    • Patients affiliated to the French Health Care System.
    • Patients ≥18 ans et ≤80 ans
    • Sarcoïdose médiastino-pulmonaire répondant aux critères diagnostiques (ATS 2020 AJRCCM)
    • Patients avec un stade radiographique II/III et une CVF<80% et symptôme(s) respiratoire(s).
    • Patients alphabétisés et parlant le français.
    • Contraception efficace chez les femmes en âge de procréer
    • Consentement éclairé et signé.
    • Affiliation au régime de la sécurité sociale.
    E.4Principal exclusion criteria
    • Other severe impairment of sarcoidosis requiring an immediate and urgent result and / or high doses of corticosteroids (neurological, cardiac, ophthalmic impairment (eg severe uveitis with ocular sequelae), laryngeal, nasosinus, renal, severe hypercalcemia).
    • Other conditions that may influence respiratory function: Chronic Obstructive Pulmonary Disease, asthma, obesity (BMI> 30), pulmonary fibrosing disease, pulmonary neoplasia.
    • Contraindication to hydroxychloroquine (hypersensitivity to the active substances or to one of the excipients, severe retinopathy or cataracts, or unilateral blindness, prolongation of QTc, taking of treatments known to prolong QT
    • Contraindication to corticosteroid therapy (hypersensitivity to the active substances or to one of the excipients, infections and active virosis, glaucoma, psychotic states not controlled by treatment, live vaccines, diabetes mellitus and uncontrolled arterial hypertension).
    • Seropositivity for HIV, HCV or HBV.
    • Patient who received systemic corticosteroid therapy or immunosuppressive therapy for at least 7 days in the previous year.
    • History of treatment with hydroxychloroquine for sarcoidosis.
    • Pregnant women.
    • Nursing women.
    • Patient under guardianship or curatorship.
    • Participation in an interventional therapeutic trial within 6 months before inclusion.
    • Atteinte sévère de la sarcoïdose autre nécessitant un résultat immédiat et urgent et/ou de fortes doses de corticoïdes (atteinte neurologique, cardiaque, ophtalmique (eg.uvéite sévère avec séquelles oculaires), laryngée, nasosinusienne, rénale, hypercalcémie sévère).
    • Autres conditions pouvant influencer la fonction respiratoire : BPCO, asthme, obésité (IMC >30), maladie fibrosante pulmonaire, néoplasie pulmonaire.
    • Contre-indication à l’hydroxychloroquine (hypersensibilité aux substances actives ou à l'un des excipients, rétinopathie ou cataracte sévère, ou cécité unilatérale, allongement du QTc, prise de traitements connus pour allonger le QT
    • Contre-indication à la corticothérapie (hypersensibilité aux substances actives ou à l'un des excipients, infections et virose évolutive, glaucome, états psychotiques non contrôlés par un traitement, vaccins vivants, diabète sucré et hypertension artérielle non contrôlés).
    • Séropositivité pour le VIH, VHC ou VHB.
    • Patient ayant reçu une corticothérapie systémique ou un traitement immunosuppresseur pendant au moins 7 jours dans l’année précédente.
    • Antécédent de traitement par hydroxychloroquine pour la sarcoïdose.
    • Grossesse en cours.
    • Allaitement.
    • Patient sous tutelle ou curatelle.
    • Participation à un essai thérapeutique interventionnel dans les 6 mois avant l’inclusion.
    E.5 End points
    E.5.1Primary end point(s)
    Difference in forced vital capacity (FVC) expressed as a percentage of the theoretical between inclusion and the 6th month.
    La différence de capacité vitale forcée (CVF) exprimée en pourcentage de la théorique entre l’inclusion et le 6e mois.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6th month
    6ème mois
    E.5.2Secondary end point(s)
    • General quality of life: quality of life questionnaire Short Form 36 item (SF-36).
    • Respiratory quality of life: Respiratory questionnaire from Saint Georges Hospital (SGRQ).
    • Fatigue: Score Fatigue assessment scale (FAS) in sarcoidosis.
    • Adverse effects of treatment :
    Hydroxychloroquine: digestive disorders (nausea, vomiting), allergic and skin disorders, ocular effects.
    Corticosteroid therapy: measurement of weight, blood pressure, collection of the presence of cushingoid facies, infectious episodes. Assessment of sleep disorders by the Pittsburg Sleep Quality Index (PSQI) and anxiety disorders by the Hospital Anxiety and Depression Scale (HADS). Search for diabetes mellitus (fasting blood sugar, HbA1c); dyslipidemia (complete lipid profile: total cholesterol, TG, HDLc, LDLc); nutritional assessment.
    • Treatment compliance: questionnaire GIRERD.
    • Respiratory function: Measurement of FVC, of ​​the maximum expired volume in 1 second (FEV1); Pulmonary Diffusion of Carbon Monoxide (DLCO); oxygen saturation; 6 minute walk test (TM6 ’).
    • Functional respiratory signs: Assessment of dyspnea by scores and scales: mMRC, Baseline and transition dyspnea Index (BDI-TDI), Dyspnea-12); Cough Assessment by Cough And Sputum Assessment-Questionnaire (casa-Q).
    • The activity and flare-ups of thoracic and extra-thoracic sarcoidosis: Evaluation of organ damage by clinical investigation, based on the tool of the Wasog sarcoidosis organ assessment instrument adapted by Bickett et al. as a score (9.10), Response to treatment: Disappearance / onset / worsening (flare) / improvement / stability of various organ damage by the extraPulmonary physician Organ Severity Tool (ePOST) (11) Sarcoidosis-Disease Activity Index (S-DAI) (12), Use during the study of immunosuppressive therapy or increased corticosteroid therapy, Biological activity assessed by serum angiotensin converting enzyme (ACE) assay (x N and IU / l), serum calcium, concentration of lymphocytes.
    • La qualité de vie générale : Questionnaire de qualité de vie généraliste : Short Form 36 item (SF-36).
    • La qualité de vie respiratoire : Questionnaire de mesure de qualité de vie chez les patients atteints de pathologie respiratoire : Questionnaire respiratoire de l’hôpital Saint Georges (SGRQ).
    • La fatigue : Score Fatigue assessment scale (FAS) particulièrement évalué dans la sarcoïdose.
    • Les effets indésirables du traitement
    Hydroxychloroquine : en particuliers troubles digestifs (nausée, vomissement), troubles allergiques et cutanées, effets oculaires.
    Corticothérapie : mesure du poids, de la pression artérielle, recueil de la présence de faciès cushingoïde, d’épisodes infectieux. Évaluation des troubles du sommeil par l'index de qualité de sommeil de Pittsburg (PSQI) et des troubles anxieux par l’Hospital Anxiety and depression scale (HADS). Recherche d’un diabète sucré (glycémie à jeun, HbA1c) ; d’une dyslipidémie (bilan lipidique complet : cholesterol total, TG, HDLc, LDLc) ; évaluation nutritionnelle.
    • L’observance des traitements : Mesure par auto-questionnaire de GIRERD.
    • La fonction respiratoire : Mesure de la CVF, du Volume expiré maximal en 1 seconde (VEMS) ; de la Diffusion pulmonaire du Monoxyde de carbone (DLCO) ; saturation en oxygène ; test de marche de 6 minutes (TM6’).
    • Les signes fonctionnels respiratoires :Évaluation de la dyspnée par les scores et échelles : mMRC, Baseline and transition dyspnea Index (BDI-TDI), Dyspnea-12) ; Évaluation de la toux par Cough And Sputum Assessment-Questionnaire (casa-Q).
    • L’activité et poussées de la sarcoïdose thoracique et extra-thoracique : Évaluation des atteintes d’organe par l’investigation clinique, appuyée sur l’outil du Wasog sarcoidosis organ assessment instrument adapté par Bickett et al. sous forme de score (9,10), Réponse au traitement : Disparition/ apparition / aggravation (poussée) / amélioration / stabilité des différentes atteintes d’organes par le extraPulmonary physician Organ Severity Tool (ePOST) (11) Sarcoidosis-Disease Activity Index (S-DAI)(12), Recours durant l’étude à un traitement immunosuppresseur ou à l’augmentation de la corticothérapie, Activité biologique évaluée par le dosage sérique de l’enzyme de conversion de l’angiotensine (ECA) (x N et UI/l), calcémie, la concentration de lymphocytes dans la NFS.

    E.5.2.1Timepoint(s) of evaluation of this end point
    At 3 month, 6 month and one year
    A 3 mois, 6 mois et un an
    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 Yes
    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) 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 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
    LVLP
    Dernière visite du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 No
    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 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 state200
    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 Decision2021-12-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-11-30
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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