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    Summary
    EudraCT Number:2014-003509-13
    Sponsor's Protocol Code Number:MLN0002-3028
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-01-19
    Trial results View 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 number2014-003509-13
    A.3Full title of the trial
    An Open-Label Phase 3b Study to Assess Mucosal Healing in Subjects With
    Moderately to Severely Active Crohn's Disease Treated With Vedolizumab
    IV
    Studio in aperto di fase 3b finalizzato alla valutazione della guarigione della mucosa in soggetti con Malattia di Crohn in fase attiva da moderata a severa , trattati con Vedolizumab per via endovenosa (EV)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Vedolizumab IV in subjects with Crohn's Disease
    Vedolizumab per via endovenosa (EV) in soggetti con Malattia di Crohn
    A.3.2Name or abbreviated title of the trial where available
    Effect of Vedolizumab IV on Mucosal Healing in Crohn's Disease
    Effetto di Vedolizumab per via endovenosa (EV) sulla guarigione della mucosa in soggetti con Malatti
    A.4.1Sponsor's protocol code numberMLN0002-3028
    A.5.4Other Identifiers
    Name:N/ANumber:N/A
    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 SponsorTAKEDA DEVELOPMENT CENTRE EUROPE LTD
    B.1.3.4CountryUnited Kingdom
    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 supportTakeda Development Centre Europe Ltd
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportTakeda Development Center Americas, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTakeda Development Centre Europe Ltd
    B.5.2Functional name of contact pointStudy Manager
    B.5.3 Address:
    B.5.3.1Street Address61 Aldwych
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeWC2B4AE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00442031168000
    B.5.5Fax number00442031168199
    B.5.6E-mailclinicaloperations@tgrd.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 Vedolizumab IV (Entyvio¿)
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Pharma A/S
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Powder for suspension for injection
    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 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 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
    Crohn's Disease
    Malattia di Crohn
    E.1.1.1Medical condition in easily understood language
    Inflammatory conditions of the large and small intestine
    Condizione di infiammazione dell'intestino tenue e dell'intestino crasso.
    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 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal 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 endoscopic remission at Week 26 as assessed by ileocolonoscopy.
    Valutare la remissione endoscopica alla Settimana 26 mediante ileocolonscopia.
    E.2.2Secondary objectives of the trial
    Part A
    -To examine the relationship among endoscopic, imaging, histological,and clinical assessments of CD.
    -To evaluate endoscopic remission at Week 14.
    -To evaluate endoscopic response at Weeks 14 and 26.
    - To evaluate clinical response assessed by Crohn's Disease Activity Index (CDAI) at Weeks 10 and 26.
    - To evaluate clinical remission assessed by CDAI at Weeks 10 and 26.
    Part B
    -To examine the relationship among endoscopic, imaging, histological,and clinical assessments of CD.
    -To evaluate endoscopic remission at Week 52.
    -To evaluate endoscopic response at Week 52.
    - To evaluate clinical response assessed by Crohn's Disease Activity Index (CDAI) at Week 52.
    - To evaluate clinical remission assessed by CDAI at Week 52.
    - To evaluate durable endoscopic remission at Week 52 in patients with endoscopic remission at Week 26.
    Parte A -Esaminare la correlazione tra valutazioni endoscopiche, mediante diagnostica per immagini, valutazioni istologiche e cliniche della malattia di Crohn -Valutare la remissione endoscopica alla sett. 14. -Valutare la risposta endoscopica alle sett. 14 e 26. -Valutare la risposta clinica mediante l'indice di attivit¿ della malattia di Crohn (CDAI) alle sett 10 e 26. -Valutare la remissione clinica mediante il punteggio CDAI alle sett 10 e 26.
    Parte B -Esaminare la correlazione tra valutazioni endoscopiche, mediante diagnostica per immagini, valutazioni istologiche e cliniche della malattia di Crohn. -Valutare la remissione endoscopica alla sett 52. -Valutare la risposta endoscopica alla sett 52. - Valutare la risposta clinica mediante l'indice di attivit¿ della malattia di Crohn (CDAI) alla sett 52. -Valutare la remissione clinica mediante il punteggio CDAI alla sett 52. -Valutare la remissione endoscopica durevole alla sett 52 in pazienti con remissione endoscopica alla sett 26.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: An MREn substudy will be conducted at selected qualified centers using a standardized MR acquisition and procedure to assess bowel wall activity.
    Only subjects from the pre-selected sites will be included in this study;these subjects will undergo an MREn assessment at the Screening and Week 26 or ET visit, unless they have contraindications to the procedure. All MREn results will be evaluated by independent central review. The MREn will be conducted at selected sites qualified to perform MREn as assessed by the imaging core lab designated by the sponsor. A standardized MREn acquisition protocol will be implemented across sites
    and detailed in an Imaging Manual. eGFR to be ssessed prior to MREn being performed. MREn will be performed prior to ileocolonoscopy. Deidentified
    MREn images will be transmitted to the imaging core lab where they will be independently analyzed by expert reviewers.
    Variables evaluated may include, but are not limited to, wall thickness, enhancement of bowel wall after contrast, mural edema, ulcerations, and perienteric vascularity. Bowel assessments will be made in a segmental manner to allow for direct comparison with ileocolonoscopy assessments (terminal ileum plus ascending, transverse, descending and sigmoid colon, and rectum). More proximal small bowel may also be assessed for abnormalities on MREn only. One or more of these (including MaRIA) will be used to assess therapeutic response and will be compared to endoscopic response (SESCD) and clinical response (CDAI) scores.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: In centri selezionati sar¿ condotto un sottostudio di entero-risonanza magnetica (MREn) mediante l'uso di una RM standard,per valutare l'attivit¿ della parete intestinale.Solo i pazienti di questi centri saranno inclusi nel sottostudio;la MREn sar¿ effettuata allo screening,alla visita alla sett. 26 e alla visita di fine studio,a meno di controindicazioni.I risultati saranno valutati da un revisore centrale indipendente.L'MREn verr¿ condotta presso centri selezionati qualificati per effettuarla, valutati da un laboratorio di imaging designato dallo sponsor.Il protocollo di acquisizione dell'MREn standard sar¿ dettagliato nel manuale di Imaging. L'eGFR verr¿ misurato prima dell'MREn. L'MREn verr¿ eseguita prima della ileocolonscopia.Le immagini ottenute mediante MREn de-identificate saranno trasmesse al laboratorio centrale dove verranno analizzate autonomamente da revisori esperti. Le variabili valutate possono includere,ma non solo, spessore della parete,miglioramento della parete intestinale dopo contrasto,edema delle pareti, ulcerazioni e vascolarit¿ perenterica.La valutazione dell'intestino verr¿ effettuata per segmenti per un confronto diretto con l'ileocolonscopia (colon ascendente,trasverso,discendente,sigmoideo e retto).L'intestino tenue prossimale pu¿ essere valutato per alterazioni.Una o pi¿ di queste valutazioni (inclusa la MaRIA) veranno usate per la risposta terapeutica e confrontate con li punteggi della risposta endoscopica (SESCD) e clinica (CDAI).
    E.3Principal inclusion criteria
    - The subject has a diagnosis of moderately to severely active CD at least 3 months prior to enrollment, with a CDAI score of 220-450 during the
    Screening Period, a SES-CD score of =7 and presence of at least one mucosal ulceration documented by recorded ileocolonoscopy at Screening assessed by the central reader.
    - The subject has CD with involvement of the ileum and/or colon that can be assessed by ileocolonoscopy.
    - The subject has demonstrated an inadequate response to, loss of response to, or intolerance of at least 1 of the following agents as defined below:
    ¿ Immunomodulators:
    i. The subject has signs and symptoms of persistently active disease despite a history of at least one 12-week regimen of oral azathioprine (=
    1.5 mg/kg) or 6-mercaptopurine (=0.75 mg/kg), OR
    ii. The subject has a history of intolerance (including but not limited to nausea/ vomiting, abdominal pain, pancreatitis, liver function test abnormalities, lymphopenia, thiopurine S-methyltransferase non wild
    type [where wild type is defined as TPMT*1/*1], infection) to at least 1 immunomodulator.
    ¿ TNF-¿ antagonists:
    i. The subject has signs and symptoms of persistently active disease despite a history of at least 1 induction with:
    a) Infliximab: 4-week regimen of 5 mg/kg, 2 doses at 2 weeks apart, OR
    b) Adalimumab: 2-week regimen of 160 mg on Day 1 and 80 mg on Day 15, OR
    c) Certolizumab: 4-week regimen of 400 mg initially at Weeks 0, 2, 4 OR
    ii. The subject has recurrence of symptoms during maintenance dosing following prior clinical benefit (discontinuation despite clinical benefit does not
    qualify), OR
    iii. The subject has a history of intolerance of infliximab, adalimumab, or certolizumab, including but not limited to, infusion-related reaction, demyelination, congestive heart failure, or infection.
    ¿ Corticosteroids
    i. Signs and symptoms of persistently active disease despite a history of at least one
    4-week induction regimen that included a dose equivalent to prednisone 30 mg
    daily orally for 2 weeks or IV for 1 week, OR
    ii. Signs and symptoms of persistently active disease despite treatment with budesonide 9 mg daily or 6 mg daily for maintenance, OR
    iii. At least one failed attempt to taper corticosteroids to below a dose equivalent to prednisone 10 mg daily orally, OR
    iv. History of intolerance to corticosteroids (including, but not limited to, Cushing's syndrome, osteopenia/osteoporosis, hyperglycemia, insomnia, and infection).
    - Soggetto con diagnosi di malattia di Crohn in fase attiva da moderata a severa da almeno 3 mesi prima dell'arruolamento,con un punteggio CDAI di 220-450 durante il periodo di screening, un punteggio endoscopico semplice per la malattia di Crohn (simple endoscopic score for Crohn's disease, SES-CD) =7e presenza di almeno un'ulcerazione della mucosa documentata, registrata mediante ileocolonscopia allo screening, valutata mediante lettura centralizzata.
    -Soggetti con malattia di Crohn che coinvolge l'ileo e/o il colon e che può essere valutato mediante ileocolonscopia.
    -Soggetti che hanno evidenziato una risposta non adeguata, una perdita della risposta o intolleranza ad almeno uno dei seguenti agenti
    ¿immunomodulatori:
    i. I soggetti hanno segni e sintomi di persistenza di malattia attiva nonostante una storia di almeno 12 settimane di regime con azatiopirina orale (=
    1.5 mg/kg) o 6-mercaptopurina (=
    0.75 mg/kg) O
    ii. Il soggetto ha una storia di intolleranza (incluso, ma non solo,nausea/vomito, dolore addominale,pancreatite, anormalità dei test funzionali del fegato, linfopenia,tiopurina S-metiltransferasi non wild type [dove per wild type si intende il TPMT*1/*1] ad almeno un immunomodulatore
    ¿antagonisti del TNF-a:
    i)Il paziente ha segni e sintomi di persistenza della malattia attiva nonostante una storia di almeno una induzione con:
    a)Infliximab:regime di 4 settimane di 5mg/kg, 2 dosi a 2 settimane lontane O
    b)Adalimumab:regime di 2 settimane di 160mg al giorni 1 e 80mg al giorni 15 O
    c)Certolizumab:regime di 4 settimane di 400mg inizialmente alla settimana 0,2,4 O
    ii) Il soggetto ha ricorrenza di sintomi durante il mantenimento della dose in seguito a un precedente beneficio clinio (l'interruzione in seguito a beneficio clinico non qualifica il paziente) O
    iii) Il soggetto ha una storia di intolleranza a infliximab, adalimumab, o certolizumab, inclusi, ma non solo,reazioni correlate all'infusione, demielinizzazione, insufficienza cardiaca congestizia, infezione.
    ¿corticosteroidi:
    i. Segni e sintomi di persistenza della malattia attiva nonostante una storia almeno un regime di induzione di 4 settimane che includa una dose equivalente a 30mg giornalieri di prednisone orale o per EV per 1 settimana,O
    ii. Segni e sintomi di persistenza della malattia attiva nonostante una storia di trattamento con 9 mg giornalieri di budesonide o 6 mg giornalieriper il mantenimento, O
    iii) Almeno un tentativo fallito di diminuzione di corticosteroide al di sotto della dose equivalente a 10 mg giornalieri di prednisone orale, O
    iv) Storia di intolleranxa ai corticosteroidi (inclusi, ma non solo, sindrome di Cushing, osteopenia/osteoporosi, iperglicemia, insonnia e infezione)
    E.4Principal exclusion criteria
    - The subject has active or latent tuberculosis, regardless of treatment history, as evidenced by any of the following:
    a) History of TB.
    b) A diagnostic TB test performed during screening that is positive, as defined by:
    i. A positive QuantiFERON® test or 2 successive indeterminate QuantiFERON tests OR
    ii. A tuberculin skin test reaction =10 mm (=5 mm in patients receiving the equivalent of >15 mg/day prednisone)
    - The subject has chronic hepatitis B (HBV) or hepatitis C (HCV) infection.
    - The subject has any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency, human immunodeficiency virus [HIV] infection, organ transplantation).
    - The subject has evidence of active C. difficile infection or is having treatment for C. difficile infection or other intestinal pathogens during
    Screening.
    - The subject has evidence of an active infection during Screening.
    - The subject has received any investigational compound within 60 days of enrollment.
    - The subject has received any biologics within 60 days of enrollment.
    - The subject has received any live vaccinations within 30 days prior to enrollment.
    - The subject has a positive PML subjective symptom checklist during screening and prior to the administration of study drug on Day 1.
    -Soggetto con tubercolosi (TB) attiva o latente, indipendmentemente dal trattaemtno ricevuto, evidenziato da:
    a) Storia di TB;
    b) Test diagnostico di TB positivo effettuato allo screening,definito come:
    i)Test QuantiFERON® positivo o 2 risultati indeterminati successivi con Test QuantiFERON® O
    ii) Test cutaneo della tubercolina con reazione =10 mm (=5 mm in pazienti che rivevono una dose di prednisone giornaliera di >15 mg/giorno)
    - Il soggetto ha un'infesione cronica da epatite B (HBV) o C (HCV)
    - Il soggetto ha una immunodeficienza identificata come congenita o acquisita (es. una immunodeficienza variabile comune, infezione da virus dell'immunodeficienza umana [HIV], trapianto di organo) .
    - Il soggetto ha evidenza di infezione attiva da C. difficile o è in trattamento per infezione da C. difficile o per altri patogeni intestinali allo screening.
    -Soggetti con qualsiasi evidenza di infezioni attive durante lo screening.
    -Soggetti che hanno ricevuto un composto sperimentale entro i 60 giorni prima del trattaemnto,
    - Soggetti trattati con prodotti biologici nei 60 giorni precedenti l'arruolamento.
    -Soggetti che hanno ricevuto un vaccino vivo nei 30 giorni precedenti l'arruolamento
    - Soggetti con elenco di controllo soggettivo per la leucoencefalopatia multifocale progressiva (LMP) positivo durante lo screening e prima della somministrazione del farmaco dello studio al giorno 1.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the proportion of subjects achieving endoscopic remission, defined as a simple endoscopic score for Crohn's Disease (SES-CD) score of = 4 at Week 26.
    L'end-point primario è la percentuali dei soggetti che raggiungono la la remissione endoscopica, definta da un punteggio endoscopico semplice per la malattia di Crohn (SES-CD) = 4 alla settimana 26
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 26
    Settimana 26
    E.5.2Secondary end point(s)
    The secondary endpoints for this study part A are:
    Proportion of subjects achieving complete mucosal healing (defined as absence of ulceration) at Week 26.
    Proportion of subjects achieving endoscopic remission at Week 14.
    Proportion of subjects with endoscopic response (defined as SES-CD reduction by =50%) at Week 14.
    Proportion of subjects with endoscopic response (defined as SES-CD reduction by =50%) at Week 26
    Proportion of subjects achieving clinical response (CDAI decrease from Baseline of =100 points) at Week 10.
    Proportion of subjects achieving clinical response (CDAI decrease from Baseline of =100 points) at Week 26
    Proportion of subjects achieving clinical remission (CDAI =150) at Week 10
    Proportion of subjects achieving clinical remission (CDAI =150) at Week 26.

    The secondary endpoints for this study part B are:
    Proportion of subjects achieving complete mucosal healing (defined as absence of ulceration) at Week 52.
    Proportion of subjects achieving endoscopic remission at Week 52.
    Proportion of subjects with endoscopic response (defined as SES-CD reduction by =50%) at Week 52.
    Proportion of subjects achieving clinical response (CDAI decrease from Baseline of =100 points) at Week 52
    Proportion of subjects achieving clinical remission (CDAI =150) at Week 52
    Proportion of subjects with durable clinical remission, defined as clinical remission at Week26 and Week 52

    ; Gli End point secondari per la parte di studio A sono:
    Percentuale dei soggetti che raggiungono la completa guarigione della mucosa (definita come assenza di ulcere) alla settimana 26
    Percentuale dei soggetti che raggiunge la remissione endoscopica alla settimana 14
    Percentuale dei soggetti che raggiunge la risposta endoscopica (definita come riduzione del SES-CD di =50%) alla settimana 14
    Percentuale dei soggetti che raggiunge la risposta endoscopica (definita come riduzione del SES-CD di =50%) alla settimana 26
    Percentuale dei soggetti che raggiungono la risposta clinica (CDAI dimunuita di =100 punti dal basale) alla settimana 10
    Percentuale dei soggetti che raggiungono la remissione clinica (CDAI =150) alla settimana 26

    Gli End point secondari per la parte di studio B sono:

    Percentuale dei soggetti che raggiungono la completa guarigione della mucosa (definita come assenza di ulcere) alla settimana 52
    Percentuale dei soggetti che raggiunge la remissione endoscopica alla settimana 52
    Percentuale dei soggetti che raggiunge la risposta endoscopica (definita come riduzione del SES-CD di =50%) alla settimana 52
    Percentuale dei soggetti che raggiungono la risposta clinica (CDAI dimunuita di =100 punti dal basale) alla settimana 52
    Percentuale dei soggetti che raggiungono la remissione clinica (CDAI =150) alla settimana 52
    Percentuale dei soggetti con remissione clinica durevole, definita come remissione clinica alla settimana 26 e settimana 52
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 10, 14 , 26 and 52
    Settimana 10, 14, 26 e 52
    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 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 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.8.2.4Number of treatment arms in the trial1
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA43
    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
    Canada
    United States
    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
    End of trial will be the date of the last visit of the last subject at Week 40 Follow-up visit.
    LVLS al follow up alla visita alla settimana 40
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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 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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 58
    F.4.2.2In the whole clinical trial 100
    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)
    The study medication will not be available upon completion of the subject's participation in the study. The subject should be returned to the care of a physician and standard therapies as required.
    Il faraco dello studio non sar¿ disponibile dopo il completamento della partecipazione del soggetto allo studio, Il pazientei dovr¿ rimettersi alle cure del medico e alle terapie standard come richiesto.
    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 Decision2016-01-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-14
    P. End of Trial
    P.End of Trial StatusCompleted
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