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    Summary
    EudraCT Number:2017-001400-29
    Sponsor's Protocol Code Number:P150302J
    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:2018-07-31
    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 number2017-001400-29
    A.3Full title of the trial
    Treatment of severe refractory systemic lupus erythematosus by injection of allogeneic mesenchymal stem cells derived from the umbilical cord - MSC SLE
    TRAITEMENT DU LUPUS ERYTHEMATEUX SYSTEMIQUE REFRACTAIRE PAR INJECTION DE CELLULES SOUCHES MESENCHYMATEUSES ALLOGENIQUES ISSUES DU CORDON OMBILICAL - MSC LES
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of systemic lupus erythematosus by injection iv of mesenchymal stem cells (MSC-LES)
    TRAITEMENT DU LUPUS ERYTHEMATEUX SYSTEMIQUE PAR INJECTION IV DE CELLULES SOUCHES MESENCHYMATEUSES ALLOGENIQUES (MSC-LES)
    A.3.2Name or abbreviated title of the trial where available
    MSC-LES
    A.4.1Sponsor's protocol code numberP150302J
    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 supportFondation du Rein (FdR) sous égide de la FRM, en partenariat avec l’AFM Téléthon et l’AIRG
    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 (AP-HP)
    B.5.2Functional name of contact pointDRCI Hôpital St Louis
    B.5.3 Address:
    B.5.3.1Street Address 1 av. Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.6E-mailkarine.seymour@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 No
    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 nameALLOGENEIC MESENCHYMAL STROMAL CELLS DERIVED FROM THE UMBILICAL CORD
    D.3.2Product code 0
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntracavernous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN0
    D.3.9.1CAS number 0
    D.3.9.2Current sponsor codeP150302
    D.3.9.3Other descriptive nameCSM allogéniques issues de cordons ombilicaux ( MTI-PP)
    D.3.10 Strength
    D.3.10.1Concentration unit 1X 100 milligrams/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1.106 to 4.106
    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
    Treatment of Systemic Lupus Erythematosus refractory to standard treatments.
    Traitement du Lupus Erythémateux Systémique réfractaire aux traitements standards.
    E.1.1.1Medical condition in easily understood language
    Patients with refractory systemic Lupus Erythematosus severe prior conventional treatments (Cyclophosphamide (CY), MMF or corticosteroids with or without corticosteroids)
    Patients atteints de Lupus Erythémateux Sytémique réfractaire sévère aux traitements classiques préalables (Cyclophosphamide (CY), MMF ou corticoïdes avec ou sans corticoïdes)
    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 10042945
    E.1.2Term Systemic lupus erythematosus
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To analyze the tolerance of the administration of allogeneic CSM in the treatment of systemic Lupus Erythematous System (SLE) refractory to conventional treatments (Cyclophosphamide (CY), MMF or corticosteroids with or without corticosteroids)
    Analyser la tolérance de l'administration de CSM allogéniques dans le traitement du Lupus Erythémateux Sytémique (LES) réfractaire sévère aux traitements classiques préalables (Cyclophosphamide (CY), MMF ou corticoïdes avec ou sans corticoïdes)
    E.2.2Secondary objectives of the trial
    1- Feasibility of the administration of allogeneic CSM in the treatment of refractory patients with refractory severe prior conventional treatments
    2- Tolerance at more than three months after injection, taking into account the morbidity observed and the overall survival of patients with SLE treated up to 1 year after the procedure (with 1 year of follow-up after the end of the study ).
    3- Analysis of clinical and biological response according to clinico-biological criteria for routine surveillance of lupus by functional scores (SELENA-SLEDAI, BILAG, SF36, EQ5D, SRI, SLICC-SLE)
    4- Analysis of the efficacy at 3 months of injection of allogeneic MSCs by evaluating the proportion of patients presenting a Major Clinical Response (MCR).
    5- Evaluate the percentage of patients with Partial Clinical Response (CPR) during the 12-month follow-up period of the study.
    6- Evaluation of the immunomodulatory action
    1- Faisabilité de l'administration de CSM allogéniques dans le traitement des patients atteints de LES réfractaires sévères aux traitements classiques préalables
    2- Tolérance à plus de trois mois après injection, en tenant compte de la morbidité observée et de la survie globale des patients atteints de LES traités jusqu'à 1 an après la procédure (avec 1 an de suivi après la fin de l'étude).
    3- Analyse de la réponse clinique et biologique selon les critères clinico-biologique de surveillance de routine du lupus par les scores fonctionnels (SELENA-SLEDAI, BILAG, SF36, EQ5D, SRI, SLICC-SLE)
    4- Analyse de l'efficacité à 3 mois de l'injection des CSM allogeniques en évaluant la proportion de patients présentant une Réponse Clinique Majeure (RCM).
    5- Evaluer le pourcentage de patients présentant une Réponse Clinique partielle (RCP) au cours des 12 mois de suivi de l'étude.
    6- Evaluation de l'action immunomodulatrice
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects:
    1- Pregnancy, breastfeeding or lack of appropriate contraception during study duration
    2- Presence of:
    a) Renal failure: calculated creatinine clearance of <30 ml / min
    b) Cardiac failure: clinical signs of congestive heart failure; left ventricular ejection fraction <40% on echocardiography; uncontrolled ventricular arrhythmia;
    c) Hepatitis defined by abnormal levels of transaminases (AST, ALT> 2 x normal) not related to disease activity.
    d) Respiratory disease: mean PAP> 50 mmHg (echocardiography), respiratory failure defined by a resting blood pressure of oxygen at PaO 2 < 70 mmHg and / or PaCO2 > 50 mmHg without oxygen
    3- Severe psychiatric disorders, including severe psychosis related to SLE, which would prevent to give informed consent or to undergo the procedure.
    4- Active neoplasia or concomitant myelodysplasia, except for basal cell carcinoma or squamous cell carcinoma or in situ cervix carcinoma.
    5- Bone marrow failure defined by neutropenia <0.5.109/L, thrombocytopenia <30. 109 / L, anemia < 8 g / dL, lymphopenia CD4 + <200 x 106 / L caused by another disease than SLE.
    6- Acute or chronic uncontrolled infection: HIV 1/2, HTLV-1/2, Hepatitis B (HBsAg surface antigen), Hepatitis C with positive PCR
    7- Patient having received belimumab within 2 months of belimumab within 2 months of Baseline, or having received rituximab or other B cell depleting biologic therapy within 6 months of Baseline
    8- Current substance abuse or recent (within 60 days) history of substance abuse
    9- Patient in periods of exclusion from the national roster of researchers
    10- Patient with Linguistic or psychological incapacity to sign informed consent
    11- Patient already included in another study at the same time.
    12- Poor patient compliance.
    13- Patient under legal protection.

    Patients :
    1- Grossesse, allaitement ou absence de contraception adaptée pendant la durée de l'étude.
    2- Affection(s) concomitante(s) sévère(s):
    a) Atteinte rénale: clearance calculée de la creatinine < 30 ml/min
    b) Atteinte cardiaque: signe clinique d'insuffisance cardiaque congestive; fraction d'éjection ventriculaire gauche < 40 % à l'échographie cardiaque; arythmie ventriculaire non contrôlée;
    c) Atteinte hépatique : Insuffisance hépatique définie par un taux anormal des transaminases (ASAT, ALAT > 2 fois la normal) non liée à l'activité de la maladie.
    d) Atteinte respiratoire: PAP moyenne > 50 mmHg (échographie cardiaque), insuffisance respiratoire définie par une pression artérielle en oxygène au repos PaO2 < 70 mmHg et / ou une PaCO2>50 mmHg, sans oxygénothérapie
    3- Troubles psychiatrique sévères, incluant la psychose sévère liée au LES, empêchant de donner par écrit un consentement éclairé ou à subir la procédure.
    4- Néoplasie active ou myélodysplasie concomitante, sauf pour le carcinome basocellulaire ou le cancer épidermoïde ou le carcinome du col de l'utérus in situ.
    5- Insuffisance médullaire définie par : neutropénie < 0,5.109/L, thrombopénie < 30.109/L, anémie < 8 g/dL, lymphopénie T CD4+ < 200 x 106/L causé par une autre affection que le lupus.
    6- Infection aiguë ou chronique non contrôlée, séropositivité VIH 1/2, HTLV1/2, Hépatite B (antigène de surface Ag HBs), Hépatite C, PCR positive
    7- Patient ayant reçu le belimumab dans les 2 mois suivant le belimumab dans les 2 mois suivant la ligne de base, ou ayant reçu un rituximab ou un autre traitement biologique appauvrissant les cellules B dans les 6 mois suivant la ligne de base
    8- L'abus de substances actuelles ou les antécédents récents (dans les 60 jours) de toxicomanie
    9- Personnes en période d'exclusion sur le fichier national des personnes se prêtant à une recherche
    10- Patient ayant une incapacité linguistique ou psychique de signer le consentement éclairé
    11- Personne déjà incluse dans une autre étude en même temps.
    12- Risque de mauvaise compliance du patient.
    13- Patient sous protection juridique.
    E.4Principal exclusion criteria
    Subjects:
    1- Pregnancy, breastfeeding or lack of appropriate contraception during study duration
    2- Presence of:
    a) Renal failure: calculated creatinine clearance of <30 ml / min
    b) Cardiac failure: clinical signs of congestive heart failure; left ventricular ejection fraction <40% on echocardiography; uncontrolled ventricular arrhythmia;
    c) Hepatitis defined by abnormal levels of transaminases (AST, ALT> 2 x normal) not related to disease activity.
    d) Respiratory disease: mean PAP> 50 mmHg (echocardiography), respiratory failure defined by a resting blood pressure of oxygen at PaO 2 < 70 mmHg and / or PaCO2 > 50 mmHg without oxygen
    3- Severe psychiatric disorders, including severe psychosis related to SLE, which would prevent to give informed consent or to undergo the procedure.
    4- Active neoplasia or concomitant myelodysplasia, except for basal cell carcinoma or squamous cell carcinoma or in situ cervix carcinoma.
    5- Bone marrow failure defined by neutropenia <0.5.109/L, thrombocytopenia <30. 109 / L, anemia < 8 g / dL, lymphopenia CD4 + <200 x 106 / L caused by another disease than SLE.
    6- Acute or chronic uncontrolled infection: HIV 1/2, HTLV-1/2, Hepatitis B (HBsAg surface antigen), Hepatitis C with positive PCR
    7- Patient having received belimumab within 2 months of belimumab within 2 months of Baseline, or having received rituximab or other B cell depleting biologic therapy within 6 months of Baseline
    8- Comorbidities requiring corticosteroid therapy
    9- Current substance abuse or recent (within 60 days) history of substance abuse
    10- Patient in periods of exclusion from the national roster of researchers
    11- Patient with Linguistic or psychological incapacity to sign informed consent
    12- Patient who has already been included in this or another study at the same time.
    13- Poor patient compliance.
    14- Patient under legal protection.
    Patient :
    1- Grossesse, allaitement ou absence de contraception appropriée pendant la durée de l'étude.
    2- Présence de :
    a) Atteinte rénale: clearance calculée de la creatinine < 30 ml/min
    b) Atteinte cardiaque: signe clinique d'insuffisance cardiaque congestive; fraction d'éjection ventriculaire gauche < 40 % à l'échographie cardiaque; arythmie ventriculaire non contrôlée;
    c) Atteinte hépatique : Insuffisance hépatique définie par un taux anormal des transaminases (ASAT, ALAT > 2 fois la normal) non liée à l'activité de la maladie.
    d) Atteinte respiratoire: PAP moyenne > 50 mmHg (échographie cardiaque), insuffisance respiratoire définie par une pression artérielle en oxygène au repos PaO2 < 70 mmHg et / ou une PaCO2>50 mmHg, sans oxygénothérapie
    e) Troubles psychiatrique sévères, incluant la psychose sévère liée au LES, empêchant de donner par écrit un consentement éclairé ou à subir la procédure.
    3- Néoplasie active ou myélodysplasie concomitante, sauf pour le carcinome basocellulaire ou le cancer épidermoïde ou le carcinome du col de l'utérus in situ.
    4- Insuffisance médullaire définie par : neutropénie < 0,5.109/L, thrombopénie < 30.109/L, anémie < 8 g/dL, lymphopénie T CD4+ < 200 x 106/L causé par une autre affection que le lupus.
    5- Infection aiguë ou chronique non contrôlée, séropositivité VIH 1/2, HTLV1/2, Hépatite B (antigène de surface Ag HBs), Hépatite C, PCR positive
    6- Patient ayant reçu le belimumab dans les 2 mois suivant le belimumab dans les 2 mois suivant la ligne de base, ou ayant reçu un rituximab ou un autre traitement biologique appauvrissant les cellules B dans les 6 mois suivant la ligne de base
    7- Comorbidités nécessitant une corticothérapie
    8- L'abus de substances actuelles ou les antécédents récents (dans les 60 jours) de toxicomanie
    9- Personnes en période d'exclusion sur le fichier national des personnes se prêtant à une recherche
    10- Incapacité linguistique ou psychique de signer le consentement éclairé
    11- Personne ayant déjà été inclus dans cette étude ou dans une autre en même temps.
    12- Risque de mauvaise compliance du patient.
    13- Patient sous protection juridique.
    E.5 End points
    E.5.1Primary end point(s)
    Immediate tolerance assessed during the injection and the first 10 days after the injection of the allogeneic MSCs, according to the side effects defined by the CTCAE standards.
    Tolérance immédiate évaluée durant l'injection et les 10 premiers jours qui suivront l'injection des CSM allogéniques, selon les effets secondaires définis par les normes CTCAE.
    E.5.1.1Timepoint(s) of evaluation of this end point
    No
    Non
    E.5.2Secondary end point(s)
    1-Feasibility of administering allogeneic MSCs in the treatment of refractory patients with refractory severe prior conventional treatments
    2-Tolerance at more than three months after injection, taking into account the morbidity observed and the overall survival of SLE patients treated up to 1 year after the procedure (with 1 year of follow-up after the end of the study ).
    3-Analysis of clinical and biological response according to clinico-biological criteria for routine lupus surveillance by functional scores (SELENA-SLEDAI, BILAG, SF36, EQ5D, SRI, SLICC-SLE)
    4-Analysis of the efficacy at 3 months of injection of allogeneic MSCs by evaluating the proportion of patients presenting a Major Clinical Response (MCR).
    5-Evaluate the percentage of patients presenting a Partial Clinical Response (CPR) during the 12 months of study follow-up.
    6-Evaluation of immunomodulatory action
    1-Faisabilité de l'administration de CSM allogéniques dans le traitement des patients atteints de LES réfractaires sévères aux traitements classiques préalables
    2-Tolérance à plus de trois mois après injection, en tenant compte de la morbidité observée et de la survie globale des patients atteints de LES traités jusqu'à 1 an après la procédure (avec 1 an de suivi après la fin de l'étude).
    3-Analyse de la réponse clinique et biologique selon les critères clinico-biologique de surveillance de routine du lupus par les scores fonctionnels (SELENA-SLEDAI, BILAG, SF36, EQ5D, SRI, SLICC-SLE)
    4-Analyse de l'efficacité à 3 mois de l'injection des CSM allogeniques en évaluant la proportion de patients présentant une Réponse Clinique Majeure (RCM).
    5-Evaluer le pourcentage de patients présentant une Réponse Clinique partielle (RCP) au cours des 12 mois de suivi de l'étude.
    6-Evaluation de l'action immunomodulatrice
    E.5.2.1Timepoint(s) of evaluation of this end point
    No
    Non
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolérance
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Analyze tolerance of administration of allogeneic MSCs
    Analyser la tolérance de l'administration des CSM allogéniques
    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 No
    E.8.1.1Randomised No
    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 Yes
    E.8.1.7.1Other trial design description
    monocentrique, phase II
    monocentric, phase II
    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.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 years3
    E.8.9.1In the Member State concerned months0
    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: 8
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2018-07-31. Yes
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    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)
    expected normal treatment of that condition
    traitement normal attendu de cette maladie
    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 Decision2018-01-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-16
    P. End of Trial
    P.End of Trial StatusOngoing
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