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    Summary
    EudraCT Number:2016-001607-23
    Sponsor's Protocol Code Number:EFC14153
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-02-12
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2016-001607-23
    A.3Full title of the trial
    A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Children 6 to <12 Years of Age with Uncontrolled Persistent Asthma
    Studio randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli volto a valutare l’efficacia e la sicurezza di dupilumab in bambini dai 6 a < 12 anni di età con asma persistente e non controllato.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of Dupilumab in Children with Uncontrolled Asthma (Liberty Asthma Voyage)
    Valutazione di dupilumab in bambini con asma non controllato (Liberty Asthma Voyage)
    A.4.1Sponsor's protocol code numberEFC14153
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02948959
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1179-4851
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/021/2017
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSanofi-Aventis Recherche & Développement
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportSanofi Recherche & Développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSANOFI S.P.A.
    B.5.2Functional name of contact pointCONTACT POINT
    B.5.3 Address:
    B.5.3.1Street AddressVIALE BODIO, 37/B
    B.5.3.2Town/ cityMILANO
    B.5.3.3Post code20158
    B.5.3.4CountryItaly
    B.5.4Telephone number0039800226343
    B.5.5Fax number00390239394168
    B.5.6E-mailinformazioni.medicoscientifiche@sanofi.com
    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 namedupilumab
    D.3.2Product code SAR231893
    D.3.4Pharmaceutical form Solution for injection 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 INNDupilumab
    D.3.9.2Current sponsor codeSAR231893
    D.3.9.3Other descriptive nameREGN668
    D.3.9.4EV Substance CodeSUB88511
    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 Yes
    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 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 namedupilumab
    D.3.2Product code SAR231893
    D.3.4Pharmaceutical form Solution for injection 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 INNDupilumab
    D.3.9.2Current sponsor codeSAR231893
    D.3.9.3Other descriptive nameREGN668
    D.3.9.4EV Substance CodeSUB88511
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number175
    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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Asthma
    Asma
    E.1.1.1Medical condition in easily understood language
    Asthma
    Asma
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of dupilumab in children 6 to <12 years of age with uncontrolled persistent asthma.
    Valutare l’efficacia di dupilumab in bambini dai 6 ai <12 anni di età con asma persistente non controllato.
    E.2.2Secondary objectives of the trial
    -To evaluate in children 6 to <12 years of age with uncontrolled persistent asthma:
    -The safety and tolerability of dupilumab.
    -The effect of dupilumab in improving patient-reported outcomes (PROs).
    -The dupilumab systemic exposure and incidence of anti-drug antibodies.
    -To explore the association between dupilumab treatment and pediatric immune responses to vaccines: any vaccination for tetanus, diphtheria, pertussis and/or seasonal trivalent/quadrivalent influenza vaccine.
    Valutare in bambini dai 6 ai <12 anni di età con asma persistente non controllato:
    - la sicurezza e la tollerabilità di dupilumab;
    - l’effetto di dupilumab nel miglioramento degli esiti riferiti dai pazienti (patient reported outcomes, PRO);
    - l’esposizione sistemica a dupilumab e l’incidenza nello sviluppare anticorpi anti-farmaco;
    - l’associazione tra il trattamento con dupilumab e la risposta immunitaria ai vaccini nei soggetti pediatrici: qualsiasi vaccinazione anti-tetano, difterite, pertosse e/o vaccino trivalente/quadrivalente contro l’influenza stagionale.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Children 6 to <12 years of age, with a physician diagnosis of persistent asthma for ≥12 months prior to Screening, based on clinical history and examination, pulmonary function parameters according to Global initiative for asthma (GINA) 2015 Guidelines and the following criteria:
    -Existing background therapy of medium-dose inhaled corticosteroids (ICS) with second controller medication (ie, long-acting β2 agonist [LABA], leukotriene receptor antagonist [LTRA], long acting muscarinic antagonist [LAMA], or methylxanthines) or high-dose ICS alone or high dose ICS with second controller, for at least 3 months with a stable dose ≥1 month prior to Screening Visit 1.
    -Pre-bronchodilator forced expiratory volume in 1 second (FEV1) ≤95% of predicted normal or pre bronchodilator FEV1/forced vital capacity (FVC) ratio <0.85 at Screening and Baseline Visits.
    -Reversibility of at least 10% in FEV1 after the administration of albuterol/salbutamol or levalbuterol/levosalbutamol reliever medication before randomization. Documented reversibility or positive airway hyperresponsiveness to methacholine within 12 months prior to Screening V1 is considered acceptable.
    -Must have experienced within 1 year prior to Screening Visit 1 a Severe Exacerbation Event.
    - Evidence of uncontrolled asthma, with at least one of the following criteria during the 4 (±1) weeks Screening Period:
    -Asthma Control Questionnaire–Interviewer Administered (ACQ-IA) ACQ-5 score ≥1.5 on at least one day of the Screening Period.
    -Use of reliever medication (ie, albuterol/salbutamol or levalbuterol/levosalbutamol), other than as a preventive for exercise induced bronchospasm, on 3 or more days per week, in at least one week during the Screening Period.
    -Sleep awakening due to asthma symptoms requiring use of reliever medication at least once during the Screening Period.
    -Asthma symptoms 3 or more days per week in at least one week during the Screening Period.
    - Bambini dai 6 ai <12 anni di età, con una diagnosi di asma persistente da ≥12 mesi prima dello Screening posta dallo sperimentatore sulla base dell’anamnesi e dell’esame clinico, dei parametri della funzione polmonare secondo le linee guida GINA 2015 della Global initiative for asthma (Iniziativa globale per l’asma, GINA) e in accordo con i seguenti criteri:
    • terapia di base di ICS a dosaggio intermedio in associazione ad un secondo farmaco per il controllo dell’asma (ovvero LABA, LTRA, LAMA o metilxantine) o ICS ad alto dosaggio in monoterapia o ICS ad alto dosaggio in associazione ad un secondo farmaco per il controllo dell’asma, in trattamento da almeno 3 mesi e a dose stabile da ≥1 mese prima della Visita 1 di screening
    • Volume espiratorio forzato in 1 secondo (forced expiratory volume in 1 second, FEV1) pre-broncodilatatore (preBD) ≤95% rispetto al normale previsto o rapporto FEV1preBD/ FVC<0,85 (rapporto tra FEV1 pre BD e Capacità Vitale Forzata) alle Visite di screening e basale.
    • Reversibilità almeno del 10% nel FEV1 dopo la somministrazione di albuterolo/salbutamolo o levalbuterolo/levosalbutamolo, valutata prima della randomizzazione. Una reversibilità documentata o un’iperreattività positiva delle vie respiratorie alla metacolina nei 12 mesi prima della V1 di screening sono ritenute accettabili.
    • Occorrenza nell’arco dell’anno precedente alla Visita 1 di screening, di un evento grave di riacutizzazione.
    • Evidenza di non controllo della malattia, con almeno uno dei seguenti criteri verificati durante il periodo di screening di 4 (±1) settimane:
    o Punteggio ACQ5-IA≥1,5 (questionario a 5 item per il controllo dell’asma - somministrato da un intervistatore) per almeno un giorno durante il periodo di screening.
    o Uso di farmaci al bisogno (ovvero albuterolo/salbutamolo o levalbuterolo/levosalbutamolo) per 3 o più giorni a settimana, in almeno una settimana durante il periodo di screening per scopi diversi dalla prevenzione del broncospasmo indotto da esercizio,
    o Risvegli notturni dovuti ai sintomi dell’asma che hanno richiesto l’uso di un farmaco al bisogno per almeno una volta durante il periodo di screening.
    o Sintomi dell’asma per 3 o più giorni a settimana in almeno una settimana durante il periodo di screening.
    E.4Principal exclusion criteria
    -Patients <6 or ≥12 years of age.
    -Patients with <16 kg bodyweight.
    -Any other chronic lung disease (cystic fibrosis, bronchopulmonary dysplasia, etc) which may impair lung function.
    -A subject with any history of life threatening asthma (ie, extreme exacerbation that requires intubation).
    -Co-morbid disease that might interfere with the evaluation of investigational medicinal product (IMP).

    • Pazienti con <6 o ≥12 anni di età.
    • Pazienti con peso corporeo <16 kg.
    • Qualsiasi altra malattia cronica del polmone (fibrosi cistica, displasia broncopolmonare ecc.) che possa compromettere la funzione polmonare.
    • Soggetti con anamnesi di asma potenzialmente fatale (ovvero riacutizzazione di grado estremo tale da richiedere l’intubazione).
    • Co-morbidità che potrebbe interferire con la valutazione del trattamento sperimentale (investigational medicinal product, IMP).
    E.5 End points
    E.5.1Primary end point(s)
    Annualized rate of severe exacerbation events during treatment period
    Tasso annuo di eventi di riacutizzazione severa durante il periodo di trattamento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, Week 52
    Basale, settimana 52
    E.5.2Secondary end point(s)
    1) Change from baseline in pre-bronchodilator % predicted forced
    expiratory volume in 1 second (FEV1)
    2) Change from baseline in pre-bronchodilator % predicted
    FEV1
    3) Time to first severe exacerbation event
    4) Time to first loss of asthma control event
    5) Change from baseline in other lung function measurements
    6) Change from baseline in morning asthma symptom score
    7) Change from baseline in evening asthma symptom score
    8) Number of nocturnal awakenings due to asthma symptoms
    requiring the use of reliever medication
    9) Number of rescue medication inhalations
    10) Assessment of Patient Reported Outcomes: Asthma Control Questionnaire
    11) Assessment of Patient Reported Outcomes: Pediatric Asthma quality of life questionnaire
    12) Assessment of IgG responses to vaccination during dupilumab
    treatment (may be analyzed as exploratory endpoint if insufficient power)
    1. Variazione percentuale del volume espiratorio forzato (FEV1) pre-broncodilatatore
    2. Variazione percentuale del volume espiratorio forzato (FEV1) pre-broncodilatatore
    3. Tempo al primo evento di riacutizzazione severa
    4. Tempo al primo LOAC
    5. Variazione rispetto al Basale in altre misure della funzione polmonare
    6. Variazione rispetto al Basale in termini di punteggio dei sintomi mattutini dell’asma
    7. Variazione rispetto al Basale in termini di punteggio dei sintomi serali dell’asma
    8. Numero di risvegli notturni dovuti ai sintomi dell’asma che richiedono l’uso di farmaci al bisogno.
    9. Numero di inalazioni di un farmaco rescue al bisogno
    10. Valutazione dei PRO: questionario di controllo dell’asma
    11. Valutazione dei PRO: questionario pediatrico sulla qualità della vita
    12. Valutazione delle risposte IgG alla vaccinazione durante il trattamento con dupilumab (potrebbe essere analizzato come endpoint esplorativo in caso di potenza insufficiente).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Baseline, Week 12
    2) Baseline, Weeks 2, 4, 8, 24, 36, 52
    3) to 4): Up to 52 weeks
    5) to 10): Baseline, Weeks 2, 4, 8, 12, 24, 36, 52
    11) Baseline, Weeks 12, 24, 36, 52
    12) 2 blood draws per vaccine scheduled:1
    prevaccination and 1 post-vaccination
    1) basale, settimana 12
    2) Basale, settimane 2, 4, 8, 24, 36, 52
    3 – 4): Fino alla settimana 52
    Da 5 a 10): Basale, settimane 2, 4, 8, 12, 24, 36, 52
    11) Basale, settimane 12, 24, 36, 52
    12) 2 prelievi di sangue per vaccino pianificato: 1 prima della vaccinazione e 1 dopo la vaccinazione
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Brazil
    Canada
    Chile
    Colombia
    Hungary
    Italy
    Lithuania
    Mexico
    Poland
    Romania
    South Africa
    Spain
    Turkey
    United States
    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
    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 months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    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: 838
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 838
    F.1.1.6Adolescents (12-17 years) No
    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
    Pediatric Patients, aged 6 - <12 years will provide assent to enter the study and their parents/legal guardians will provide consent.
    Pazienti pediatrici, di età compresa tra i 6 anni e <12 anni che forniranno un assenso ad entrare nello studio e per i quali i loro genitori/ rappresentanti legali forniranno il consenso.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 243
    F.4.2.2In the whole clinical trial 838
    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)
    Patients who complete treatment, can be considered for eligibility into the a long term extension study.
    Per i pazienti che completeranno il trattamento verrà valutata l’eleggibilità in uno studio di estensione a lungo termine.
    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 Decision2017-08-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-24
    P. End of Trial
    P.End of Trial StatusOngoing
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