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    Summary
    EudraCT Number:2016-003100-30
    Sponsor's Protocol Code Number:EFC13429
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-05-14
    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 number2016-003100-30
    A.3Full title of the trial
    A Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT)
    Studio multicentrico, in aperto, a braccio singolo, prima e dopo la modifica della terapia (cross-over), per
    valutare l'efficacia, la sicurezza e la tollerabilità di alemtuzumab in pazienti pediatrici affetti da sclerosi multipla recidivante-remittente (SM-RR), con malattia attiva e già in trattamento con terapia in grado di modificare il decorso della malattia (DMT)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMT
    Studio per valutare l'efficacia, sicurezza e tollerabilità di Alemtuzumab in pazienti pediatrici affetti da sclerosi multipla recidivante-remittente SM-RR e già in trattamento con terapia in grado di modificare il decorso della malattia (DMT)
    A.3.2Name or abbreviated title of the trial where available
    na
    na
    A.4.1Sponsor's protocol code numberEFC13429
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/170/2016
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGENZYME CORPORATION
    B.1.3.4CountryUnited States
    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 supportGenzyme Corporation
    B.4.2CountryUnited States
    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 number800226343
    B.5.5Fax number0239394168
    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 Yes
    D.2.1.1.1Trade name Lemtrada
    D.2.1.1.2Name of the Marketing Authorisation holderGenzyme Therapeutics Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNalemtuzumab
    D.3.9.1CAS number 216503-57-0
    D.3.9.2Current sponsor codeGZ402673
    D.3.9.4EV Substance CodeSUB12459MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeAnticorpo monoclonale umanizzato
    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
    Multiple Sclerosis
    Sclerosi Multipla
    E.1.1.1Medical condition in easily understood language
    Multiple Sclerosis
    Sclerosi Multipla
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10028245
    E.1.2Term Multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system 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, safety, and tolerability of alemtuzumab (IV) in pediatric patients from 10 to <18 years of age with RRMS who have disease activity on prior DMT.
    Valutare l’efficacia, la sicurezza e la tollerabilità di
    alemtuzumab somministrato per via endovenosa (EV) a
    pazienti pediatrici di età compresa tra 10 e <18 anni affetti
    da SMRR con malattia attiva, già in trattamento con DMT
    E.2.2Secondary objectives of the trial
    To assess the pharmacokinetics (PK), pharmacodynamics (PD), anti-drug antibody (ADA) formation, and potential effects of alemtuzumab on other multiple sclerosis (MS) disease characteristics such as cognition and quality of life (QoL).
    Valutare la farmacocinetica (PK), la farmacodinamica (PD), la formazione di anticorpi anti-farmaco (ADA) e i possibili effetti di alemtuzumab su altre caratteristiche della sclerosi multipla (SM) quali le proprietà cognitive e la qualità della vita (QoL)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patients with RRMS aged from 10 years to less than 18 years at study entry are eligible. Patients should meet the criteria of diagnosis of MS as defined by the International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for pediatric MS and the criteria of MS based on McDonald criteria 2010.
    -Signed informed consent/assent obtained from patient and patient’s legal representative (parent or guardian) according to local regulations.
    -Expanded Disability Status Scale (EDSS) score of 0.0 to 5.0 (inclusive) at screening.
    -At least 2 recorded MS attacks and at least 1 MS attack (relapse) in the last year during treatment with a interferon-beta (IFNB) or glatiramer acetate (GA) after having been on that therapy for at least 6 months
    -At least 1 of the following:
    -≥1 new or enlarging T2 hyperintense lesion or gadolinium enhancing lesion* while on that same prior therapy (IFNB or GA), OR
    -Two or more relapses in the prior year, OR
    -Tried at least 2 MS DMTs.
    I pazienti affetti da SMRR di età compresa tra 10 anni e < 18 anni non ancora compiuti al momento del loro ingresso nello studio, sono ritenuti eleggibili. I pazienti devono soddisfare i criteri diagnostici della SM definiti dal Gruppo di studio internazionale sulla sclerosi multipla pediatrica per la SM pediatrica e sui criteri della SM basati su quelli della classificazione di McDonald del 2010.
    -Ottenimento dei moduli di consenso/assenso informato firmati dai pazienti e dai legali rappresentanti dei pazienti (genitori o tutori legali) in conformità con le normative vigenti.
    -Punteggio da 0 a 5 (incluso) della Scala allargata sullo
    stato di disabilità (EDSS) allo Screening.
    -Manifestazione di almeno 2 attacchi di SM documentati e di almeno 1 attacco di SM (recidiva) nel corso dell’ultimo anno durante un trattamento con terapia a base di interferone beta (IFNB) o di glatiramer acetato (GA), a seguito di un periodo di trattamento di almeno 6 mesi.
    -Manifestazione di almeno 1 dei seguenti eventi:
    - ≥1 lesioni iperintense in T2 nuove o di aumentate
    dimesnioni oppure lesioni evidenziate dal gadolinio nel
    corso di quella stessa precedente terapia (con IFNB o
    GA), OPPURE
    - 2 o più recidive nel corso dell’anno precedente,
    OPPURE
    - sono state provate almeno 2 DMT per la SM.
    E.4Principal exclusion criteria
    -Any progressive or non-relapsing forms of MS.
    -Conditions/situations such as:
    -Impossibility to meet specific protocol requirements.
    -Current participation in another interventional clinical study.
    -Patient is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
    -Uncooperative patient or any condition that could make the patient potentially non-compliant tothe study procedures in the opinion of the Investigator.
    -Mental condition rendering the patient or parent/guardian unable to understand the nature, scope, and possible consequences of the study.
    -Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult or that would put the patient at risk by participating in the study in the opinion of the Investigator.
    -History of drug or alcohol abuse.
    -History of known human immunodeficiency virus (HIV) positivity.
    -Pregnant or breast-feeding female patients or those who plan to become pregnant during the study.
    -Unwilling to agree to use a reliable and effective contraceptive method as defined for contraception in the Informed Consent form (ICF) when receiving a course of alemtuzumab treatment and for 4 months following that course of treatmenty (fertile patients only).
    -Female patients who have commenced menstruating (ie, are of childbearing potential) and are unwilling or unable to be tested for pregnancy.
    -Previous treatment with alemtuzumab
    -Treatment with natalizumab, daclizumab, fingolimod, methotrexate, azathioprine, cyclosporine, or mycophenolate mofetil in the last 6 months prior to screening, or as determined by the treating physician to have residual immune suppression from these or other MS treatments.
    - Treatment with teriflunomide in the last 12 months except if the patient underwent the recommended elimination procedure as per SmPC.
    -Previous treatment with mitoxantrone, cyclophosphamide, cladribine, rituximab, ocrelizumab, leflunomide, or any cytotoxic therapy.
    -Previous treatment with any investigational medication (drug that has not been approved at any dose or for any indication). Use of an investigational medication that was subsequently licensed and nonstandard use of a licensed medication (eg, using a dose other than the dose that is stated in the licensed product labeling or using a licensed therapy for an alternative indication) is not exclusionary. Prior treatment with herbal medications or nutritional supplements is also permitted.
    -Intolerance of pulsed corticosteroids, especially a history of steroid psychosis.
    -History of malignancy
    -Prior documented history of thrombocytopenia, or platelet count at screening < lower limits of normal (LLN).
    -Any disability acquired from trauma or another illness that, in the opinion of the Investigator, could interfere with evaluation of disability due to MS.
    -Patients with known Type 1 hypersensitivity or anaphylactic reactions to the active substances or any of the excipients, or intolerance of acyclovir or its therapeutic equivalent
    -Major systemic disease or other illness that would, in the opinion of the Investigator, compromise patient safety or interfere with the interpretation of study results, eg, current peptic ulcer disease, or other conditions that may predispose to hemorrhage, immune cytopenias, rheumatoid arthritis, systemic lupus erythematosus, other connective tissue disorders, vasculitis, inflammatory bowel disease, severe psoriasis.
    -Medical, psychiatric, cognitive, or other conditions that, in the Investigator’s opinion, compromise the patient’s ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study.
    -Major psychiatric disorder that is not adequately controlled by treatment in the opinion of the Investigator.
    -Epileptic seizures that are not adequately controlled by treatment.
    -Magnetic resonance imaging (MRI)-related conditions: conditions that could interfere with MRI acquisition and/or interpretation of MRI results (eg, claustrophobia, orthopedic implants/treatments, orthodontic treatments etc.).
    -Known bleeding disorder (eg, dysfibrinogenemia, factor IX deficiency, hemophilia, Von Willebrand’s disease, disseminated intravascular coagulation [DIC], fibrinogen deficiency, clotting factor deficiency).
    -Prior history of invasive fungal infections
    -Active infection, eg, deep-tissue infection, that the Investigator considers sufficiently serious to preclude study participation.
    -In the Investigator’s opinion, patient is at high risk for infection (eg, indwelling catheter, dysphagia with aspiration, decubitus ulcer, history of prior aspiration pneumonia or recurrent urinary tract infection).
    Qualsiasi forma progressiva o non recidivante di SM. Condizioni/situazioni come: Impossibilità di rispondere ai requisiti specifici del protocollo.Partecipazione attuale ad altro studio clinico interventistico.Il pz è il PI o il SInv, assist. di ricerca, farmacista, study coordinator, altro staff o parenti di coloro i quali sono direttamente coinvolti nella conduzione del protocollo.Pz non collaborativi o qualsiasi altra condizione che potrebbe rendere il pz potenzialmente non compliante alle procedure dello studio secondo parere del med.Condizioni mentale che rende il pz o chi se ne prende cura incapace di capire la natura, scopo,e possibile conseguenza dello studio.Malattie, cardiovascolari, epatiche, neurologiche, endocrine clinicamente rilevanti, o altre gravi patologie sistemiche che possono rendere l'implement. del protocollo o l'interpretazione dei risultati dello studio difficile, o che, secondo opinione del medico, potrebbero mettere a rischio il pz qualora partecipasse allo studio.Storia di abuso di droga o alcool.Positività nota all'immunodeficienza acquisita umana (HIV).Pz gravide o in allattamento o che hanno pianificato una gravidanza durante lo studio.Pz riluttanti ad accettare di usare metodi contraccettivi affidabili ed efficaci, come definito nel CI, quando ricevono un ciclo di tratt. con Alemtuzumab e per i 4 mesi succesivi a questo ciclo di tratt. (solo per pz fertili).Pz donne che hanno avuto il ciclo mestruale (es.sono in età fertile) e sono riluttanti o non abili a essere testate per la gravidanza.Trattam. precedenti con Alemtuzumab.Tratt. con natalizumab, daclizumab, fingolimod,metotrexato, azatioprina, ciclosporina o micofenolato mofetile nel corso degli ultimi 6 mesi o presenza di una soppr. del sistema immunitario residua derivante da questi o da altri trattamenti per la SM secondo quanto stabilito dal medico respons. del tratt..Tratt. con teriflunomide nel corso degli ultimi 12 mesi, eccetto se il pz è stato sottoposto alla procedura di eliminazione accelerata secondo le indicazioni riportate nell’’etichetta locale di teriflunomide.Precedente tratt. con mitoxantrone, ciclofosfamide, cladribina, rituximab, ocrelizumab, leflunomide o qualunque terapia citotossica.Tratt. precedente con qualsialsi altro medicinale sperimentale (farmaco che non è stato approvato in nessun dosaggio o indicazione). Uso di altro medicinale sperimentale che è stato successivamente autorizzato e uso non standard di medicinale autorizzato (es.utilizzo di una dose diversa da quella indicata in etichetta del prodotto autorizzato o uso di terapia autorizzata per una indicazione alternativa) non è criterio di esclusione.E' anche permesso un precedente tratt. con erbe medicali o supplementi nutrizionali.Intolleranza ai Corticosteroidi, specialmente storia di psicosi steroidea.Anamnesi di tumori.Precedente anamnesi documentata di piastrinopenia o conta piastrinica <LLN allo Screening.Qualsiasi disabilità acquisita da trauma o altra malattia che, a parere del medico, potrebbe interferire con la valutazione della disabilità dovuta a SM.Pz con nota ipersensibilità di tipo 1 o reazioni anafilattiche a sostanze attive o ad altri eccipienti, o intolleranza ad aciclovir o ai suoi equivalenti terapeutici.Gravi patologie sistemiche o altre patologie che potrebbero, nell'opinione del medico, compromettere la sicurezza del pz o interferire con l'interpretazione dei risultati dello studi, es. ulcera peptica in atto o altre condizioni che possono predisporre all'emorragia, immunocitopenia, artite reumatoide, lupus sistemico eritematoso, altre patologie del tessuto connettivo, vasculiti, patologie infiammatorie dell'intestino, psoriasi severa.Condizioni, mediche, psichiatriche e cognitive che, secondo l'opinione del medico, compromettono l'abilità del pz di capire l'informativa del paziente, a dare il consenso informato, essere compliante con il disegno del protocollo o completare lo studio.Grave patologia psichiatrica che non è adeguatamente controllata dal tratt. secondo opinione del medico.- crisi epilettiche non adeguatamente controllate dal tratt.-Condizioni correlate a Risonanza magnetica (RMI): condizioni che possono interferire con l'acquisizione dell'immag. della RMI e /o l'interpretazione dei risultati della RMI (es: claustrofobia, impianti ortopedici/ trattamenti, tratt. ortodontici, ecc.).Patologie note di sanguinamento (es.disfibrinogemia, deficienza del fattore IX, emofilia, Patologia di Von Willebrand,coagulazione intravascolare disseminata (DIC), fibrinogeno deficienza, deficienza dei fattori della coagulazione). Anamenesi di infezioni fungine invasive.Infez. attive, es. infezioni del tessuto profondo, che il PI considera sufficientemente serie da precludere la partecip. allo studio.Secondo parere del medico, pz ad alto rischio infettivo (catetere in sito,disfagia con asp., ulcera da decubito,anamnesi di polmonite da aspirazione o infez. urinarie ricorrenti.
    E.5 End points
    E.5.1Primary end point(s)
    Number of new or enlarging T2 lesions during continuation of prior DMT (Period 1) compared to an equal period after the first course of alemtuzumab treatment (Period 2)
    Numero di lesioni in T2 nuove o di aumentate dimensioni durante la continuazione della precedente DMT (Periodo 1) rispetto a un periodo di uguale durata successivo al primo ciclo di trattamento con alemtuzumab (Periodo 2)
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 mesi
    E.5.2Secondary end point(s)
    1) Number of patients with new or enlarging T2 lesions during continuation of prior DMT (Period 1) compared to an equal period after the first course of alemtuzumab treatment (Period 2) 2) Annualized relapse rate (ARR) 3) Assessment of cognition test scores throught Brief Visuospatial Memory Test 4) Assesment of generic pediatric QoL measures 5) Assessment of PK parameter: maximum concentration (Cmax) 6) Assessment of PK parameter: time to Cmax (Tmax) 7) Assessment of PK parameter: area under plasma concentration (AUC) 8) Assessment of PD parameter: lymphocite phenotyping 9) Number of patients with adverse events 10) Assessment of development of anti-alemtuzumab antibodies
    1) Numero di pazienti con lesioni in T2 nuove o di aumentate dimensioni durante la continuazione della precedente DMT (Periodo 1) rispetto a un periodo di uguale durata successivo al primo ciclo di trattamento con alemtuzumab (Periodo 2). 2) Tasso annualizzato di recidive (ARR) 3) Punteggi del test cognitivo: Test della memoria visiva e spaziale a breve termine – 4) Strumenti generici validati per la valutazione della QoL in età pediatrica 5) Misurazione parametri PK: Concentazione massima (Cmax) 6) Misurazione parametri PK: Tempo per raggiungimento Cmax 7) Misurazione parametri PK: Concentrazione espressa come area sotto la curva AUC 8) Valutazione della PD comprensiva dei sottotipi linfocitari 9) Numero di pazienti con eventi avversi 10) Valutazione dello sviluppo di anticorpi anti-alemtuzumab
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months 2) at year 2 3) and 4) every 6 months over 2 years 5) to 7) 2 years 8) until month 60 9) 4 years after last dose of alemtuzumab 10) at Baseline, month 1, month 3, month 12, month 13, month 15, month 24
    12 mesi 2) All'anno 2 3 e 4) ogni 6 mesi nel corso dei 2 anni 5, 6, 7) 2 anni 8) fino al mese 60 9) 4 anni dopo l'ultima dose di Alemtuzumab 10) al basale e ai Mesi 1, 3,12, 13, 15 e 24
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    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
    Cognition and Quality of Life
    le proprietà cognitive e la qualità della
    vita (QoL)
    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 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 No
    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 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 EEA30
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Belgium
    Bulgaria
    Czech Republic
    France
    Germany
    Greece
    Italy
    Netherlands
    Norway
    Poland
    Portugal
    Russian Federation
    Spain
    Sweden
    Switzerland
    Turkey
    United Kingdom
    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 years6
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 1
    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: 10
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 55
    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 Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Population : <18
    Popolazione:<18
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 43
    F.4.2.2In the whole clinical trial 65
    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
    nessuno
    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 Decision2017-04-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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