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    The EU Clinical Trials Register currently displays   41018   clinical trials with a EudraCT protocol, of which   6709   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2018-002632-24
    Sponsor's Protocol Code Number:P160915
    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:2018-07-20
    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 number2018-002632-24
    A.3Full title of the trial
    Therapeutic plasma exchange, rituximab and intravenous immunoglobulins (IVIg) for severe acute exacerbation of idiopathic pulmonary fibrosis admitted in ICU: an open, randomized, controlled trial
    Les échanges plasmatiques thérapeutiques, le rituximab et les immunoglobulines intraveineuses (IgIV) pour l'exacerbation aiguë sévère de fibrose pulmonaire idiopathique (EA-FPI) chez les patients admis en réanimation: essai ouvert, randomisé et contrôlé.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    to evaluate a triple therapy: plasma exchange, rituximab, intravenous immunoglobulin (IVIg) and corticosteroid administration compared to standard corticosteroid therapy in patients for severe acute exacerbation of idiopathic pulmonary
    Evaluer l'impact sur la mortalité globale au 28ème jour après le début des échanges plasmatiques, rituximab, immunoglobulines intraveineuses (IVIg) et l’administration de corticoïdes par rapport à la corticothérapie standard chez les patients pour l’exacerbation aiguë sévère de fibrose pulmonaire idiopathique

    A.3.2Name or abbreviated title of the trial where available
    EXCHANGE-IFP
    EXCHANGE-IFP
    A.4.1Sponsor's protocol code numberP160915
    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 supportAPHP
    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 St Louis
    B.5.3 Address:
    B.5.3.1Street Address1 av. Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number0144841717
    B.5.5Fax number0144841701
    B.5.6E-mailfadila.amerali@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 RIXATHON 500 mg
    D.2.1.1.2Name of the Marketing Authorisation holderSANDOZ GmbH
    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.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 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 PRIVIGEN 100mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderCGL Behring
    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.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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) Yes
    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 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.2.1.2Country 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.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Oral use
    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: 4
    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.2.1.2Country 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.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Oral use
    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
    severe acute exacerbation of idiopathic pulmonary fibrosis
    Exacerbation aiguë de Fibrose Pulmonaire Idipatique
    E.1.1.1Medical condition in easily understood language
    idiopathic pulmonary fibrosis
    Fibrose Pulmonaire Idipatique
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    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
    The main objective is to evaluate the impact on overall mortality at day 28 after initiation of plasma exchanges, rituximab, intravenous immunoglobulins (IVIg), and corticosteroid administration versus standard corticosteroid therapy in hypoxemic patients admitted in ICU for severe acute exacerbation of idiopathic pulmonary fibrosis with PaO2/FiO2 ratio below 200.
    Evaluer l'impact sur la mortalité globale au 28ème jour après le début des échanges plasmatiques, rituximab, immunoglobulines intraveineuses (IVIg) et l’administration de corticoïdes par rapport à la corticothérapie standard chez les patients hypoxémiques admis en réanimation pour l’exacerbation aiguë sévère de fibrose pulmonaire idiopathique avec un rapport PaO2/FiO2<200.
    E.2.2Secondary objectives of the trial
    -To compare the overall mortality at day 90, at 6 months and at 12 months after the initiation of therapy
    -To compare the exposition to mechanical ventilation
    -To compare the length of ICU and hospital-stay
    -To compare the evolution of SOFA score
    -To compare the radiological evolution
    -To compare the evolution of lung injury biomarkers in serum
    -To compare the evolution of autoantibodies levels before and after therapy
    -To compare the evolution of blood fibrocytes proportions
    -To evaluate respiratory functional at 3months and compare data previously available
    -To assess the quality of life (SF36), autonomy (ADL) and muscle strength scores (MRC) at 3 months of inclusion
    -To compare the occurrence of healthcare-associated infection
    -To describe the specific complications associated to the experimental treatment
    Comparer la mortalité globale à J90, à 6 mois et à 12 mois après le début du traitement ;
    Comparer l'exposition à la ventilation mécanique ;
    Comparer la durée de séjour en réanimation et d’hospitalisation ;
    Comparer l'évolution du score SOFA ;
    Comparer l'évolution radiologique ;
    Comparer l'évolution des biomarqueurs des lésions pulmonaires dans le sérum ;
    Comparer l’évolution des quantités d'auto-anticorps circulants avant et après la thérapie ;
    Comparer l'évolution de la proportion de fibrocytes dans le sang ;
    Évaluer la fonction respiratoire à 3 mois et comparer les données précédemment disponibles ;
    Évaluer les scores de qualité de vie (SF36), d'autonomie (ADL) et de force musculaire (MRC) à 3 mois d'inclusion.
    Comparer l’apparition d'une infection associée aux soins de santé ;
    Décrire les complications spécifiques associées au traitement expérimental.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Patient ≥ 18 years of age and < 75 years
    2.Admitted to ICU in the last 72 h
    3.Definite or probable IPF diagnosis defined on 2011 ATS/ERS/JRS/ALAT guidelines or a possible usual interstitial pneumonia pattern on HRCT without etiology.
    4.Definite AE-IPF according to the 2016 revised criteria :
    a) Previous or concurrent diagnosis of idiopathic pulmonary fibrosis (if the diagnosis of IPF is not previously established, this criterion can be met by the presence of radiologic and or histopathologic changes consistent with usual interstitial pneumonia (UIP) pattern on the current evaluation);
    b) Acute worsening or development of dyspnea typically of less than one-month duration;
    c) Computed tomography with new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with a UIP pattern (if no previous computed tomography is available, the qualifier “new” can be dropped);
    d) Deterioration not fully explained by cardiac failure or fluid overload.
    5.PaO2/FiO2 ratio < 200
    1. ≥ 18 ans et <75 ans ;
    2. Admis en réanimation au cours des 72 dernières heures ;
    3. Diagnostic de FPI défini défini selon les guidelines ATS / ERS / JRS / ALAT de 2011 ou un profil de pneumonie interstitielle possible sur le scanner sans étiologie ;
    4. Exacerbation aiguë de FPI défini selon les critères révisés 2016:
    a) Diagnostic antérieur ou concomitant d'une fibrose pulmonaire idiopathique (si le diagnostic d'IPF n'est pas préalablement établi, ce critère peut être rencontré par la présence de modifications radiologiques et / ou histopathologiques compatibles avec le profil habituel de pneumonie interstitielle (UIP) sur l'évaluation actuelle);
    b)Aggravation aiguë ou développement de la dyspnée typiquement de moins d'un mois;
    c)Tomographie informatisée avec une nouvelle opacité bilatérale du verre dépoli et / ou une consolidation superposée sur un motif de fond cohérent avec un motif UIP (si aucune tomodensitométrie antérieure n'est disponible, le qualificatif "nouveau" peut être supprimé);
    d)La détérioration n'est pas entièrement expliquée par une insuffisance cardiaque ou une surcharge hydrique
    5. Rapport PaO2 / FiO2 <200.
    E.4Principal exclusion criteria
    1.Known hypersensitivity intravenous immunoglobulins or rituximab
    2.Severe heart failure
    3.Active and uncontrolled bacterial fungal or parasitic infection
    4.Positive multiplex PCR for Influenzae A and B, and for VRS
    5.Deep Veinous Thrombosis or Pulmonary embolism in the last six months
    6.Prior exposures to human-murine chimeric antibodies
    7.Ongoing treatment with a cellular immunosuppressant (e.g., cyclophosphamide, methotrexate, mycophenolate, azathioprine, calcineurin inhibitors, etc.)
    8.Subject treated with more than 2 boluses of methylprednisolone (total dose > 500mg of methylprednisolone) or one dose > 10mg/kg in the last 72 hours
    9.Uncorrectable coagulopathies or thrombocytopenia < 30000/mm3
    10.Active cancer (other than basal cell carcinoma of the skin)
    11.Other source of immunosuppression (i.e. HIV infection, solid organ transplant, lymphoma or leukemia)
    12.Pregnancy
    13.Patient listed for lung transplantation
    14.Patient on ECMO
    15.Patient with a do-not-intubate order at admission to ICU
    16.Concurrent participation in other experimental trials
    17.Not Affiliation to the French social security
    18.Not Written informed consent from the patient or a legal representative if appropriate
    1.Hypersensibilité connu des immunoglobulines intraveineuses ou rituximab ;
    2.Insuffisance cardiaque sévère ;
    3.Infection bactérienne, fongique ou parasitaire active et non contrôlée ;
    4.PCR multiplex positive à Influenzae A et B, et à VRS ;
    5.Thrombose veineuse profonde ou embolie pulmonaire au cours des 6 derniers mois ;
    6.Expositions antérieures à des anticorps chimériques ;
    7.Traitement en cours avec un immunosuppresseur cellulaire (exemple : cyclophosphamide, méthotrexate, mycophénolate, azathioprine, inhibiteurs de la calcineurine etc…) ;
    8.Sujet traité avec plus de 2 bolus de méthylprednisolone ( dose totale > 500 mg de méthylprednisolone) ou une dose de plus de 10mg/kg dans les dernières 72 heures ;
    9.Coagulopathies non corrigibles ou thrombocytopénie < 30000/mm3 ;
    10.Cancer actif (autre que le carcinome basocellulaire de la peau) ;
    11.Autre source d’immunosuppression (par exemple : infection VIH, transplantation d’organe solide, lymphome ou leucémie) ;
    12.Grossesse ;
    13.Patient répertorié pour une transplantation pulmonaire ;
    14.Patient sous ECMO ;
    15.Limitations thérapeutiques à l’admission en réanimation (décision de non-intubation);
    16.Participation simultanée à d’autres essais expérimentaux ;
    17.Non affiliation à un régime de sécurité sociale française ;
    18.Absence de consentement éclairé, écrit et signé du patient ou d’un représentant légal si approprié.
    E.5 End points
    E.5.1Primary end point(s)
    the mortality rate from randomization to Day 28 after initiation of treatment.
    La mortalité globale à J28 après le début du traitement (J1).
    E.5.1.1Timepoint(s) of evaluation of this end point
    end of the trial
    à la fin de l'étude
    E.5.2Secondary end point(s)
    1.Overall mortality at day 90, at 6 months and at 12 months
    2.Number of days alive without mechanical ventilation between day 1 and day 28
    3.Length of ICU-stay and hospital-stay
    4.Changes from D1 in SOFA score at D3, D7, D16, D21, D28 or discharge-day from ICU as appropriate (in case of death before D28, the last SOFA score collected will be 24 points)
    5.Variation of global extent of HRCT infiltrates between initial HRCT and D90 according to Akira et al. [49]
    6.Changes in lung injury biomarkers in serum (KL-6, SP-D) from D1 to D16, D21, D28 and D90
    7.Changes in circulating autoantibodies levels (anti-periplakin, anti-HSP70 and anti-vimentin antibodies) from D1 to D28 and D90
    8.Changes in the proportion of blood fibrocytes from D1 to D16, D28 and D90
    9.Proportion of patients with at least one episode of any healthcare-associated infection between inclusion and D28
    1.Mortalité globale à J90, à 6 mois et à 12 mois ;
    2.Nombre de jours de vie sans ventilation mécanique entre l'inclusion (J1) et J28 ;
    3.Durée d’hospitalisation en réanimation et séjour hospitalier ;
    4.Changements du score SOFA de J1 comparativement à J3, J7, J16, J21, J28 ou au jour de sortie de réanimation selon le cas (en cas de décès avant J28, le dernier score de SOFA recueilli sera de 24 points) ;
    5.Variation de l'étendue globale des scanners thoraciques entre le scanner initial et celui à J90 ;
    6.Modifications des biomarqueurs sériques de lésions pulmonaires (KL-6, SP-D) de J1 à J16, J21, J28 et J90 ;
    7.Modifications des taux d'anticorps circulants (anticorps anti-périplaquine, anti-HSP70 et anti-vimentine) de J1 à J28 et J90 ;
    8.Changements dans la proportion des fibrocytes sanguins de J1 à J16, J8 et J90 .
    9.Proportion de patients ayant au moins un épisode d'infection associée à un problème de santé entre l'inclusion et J28 ;
    E.5.2.1Timepoint(s) of evaluation of this end point
    at the end of the trial
    à la fin de la recherche
    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 concerned18
    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 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
    LVLS
    Dernière visite du dernier patient inclus
    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 months48
    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.1.3Elderly (>=65 years) Yes
    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 Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    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 state40
    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 Decision2018-10-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-13
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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