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    Summary
    EudraCT Number:2016-000522-18
    Sponsor's Protocol Code Number:REDUCE-RISKincd-PBID-TRIAL
    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:2021-06-08
    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 number2016-000522-18
    A.3Full title of the trial
    Risk-stratified randomized controlled trial in paediatric Crohn¿s Disease: Methotrexate versus Azathioprine or Adalimumab for mantaining remission in patients at low or at high risk for aggressive disease course, respectively ¿ a treatment strategy
    Studio randomizzato controllato in pazienti pediatrici affetti da Malattia di Crohn stratificati per classi di rischio: Methotrexate a confronto con Azatioprina o Adalimumab per il mantenimento dello stato di remissione rispettivamente nei pazienti a basso o alto livello di rischio per decorso aggressiva della malattia.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of the effectiveness of treatment with an immunosuppressant medication over another or with respect to a biological drug in the maintenance of remission in children suffering from Crohn's Disease.
    Confronto dell¿efficacia di una terapia con un farmaco immunosoppressore rispetto ad un altro o rispetto ad un farmaco biologico nel mantenimento della remissione nel bambino affetto da Malattia di Crohn.

    A.3.2Name or abbreviated title of the trial where available
    REDUCE-RISKincd-PBID-TRIAL
    REDUCE-RISKincd-PBID-TRIAL
    A.4.1Sponsor's protocol code numberREDUCE-RISKincd-PBID-TRIAL
    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 SponsorUMBERTO I - POLICLINICO DI ROMA
    B.1.3.4CountryItaly
    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 supportPIBDNet
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDipartimento di Pediatria
    B.5.2Functional name of contact pointUnit¿ funzionale del "contact-point
    B.5.3 Address:
    B.5.3.1Street Address viale Regina Elena 324
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00161
    B.5.3.4CountryItaly
    B.5.4Telephone number0649979324
    B.5.5Fax number0649979324
    B.5.6E-mailgastropediatria@uniroma1.it
    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 METHOTREXATE - 20 MG/0.8 ML SOLUZIONE INIETTABILE 4 SIRINGHE PRERIEMPITE MONOUSO DA 1.25 ML
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER ITALIA S.R.L.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameMethotrexate
    D.3.2Product code N.A
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product 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 No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name HUMIRA - 40MG/0.8ML SOLUZ. INIETTABILE- USO SOTTOCUTANEO-FLACONCINO(VETRO) 0.8ML 2 ASTUCCI:1 FLACONCINO+1SIRINGA+1AGO+1ADATT.STERILE-2TAMPONI IMBEVUTI ALCOOL
    D.2.1.1.2Name of the Marketing Authorisation holderABBVIE LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameHumira
    D.3.2Product code N.A
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous 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 No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name AZATIOPRINA ASPEN - 50 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderASPEN PHARMA TRADING LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameAzatioprina
    D.3.2Product code N.A
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product 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 No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name PURINETHOL - 50 MG COMPRESSE25 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderASPEN PHARMA TRADING LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 namePurinethol
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product 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 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
    Crohn Disease
    Malattia di Crohn
    E.1.1.1Medical condition in easily understood language
    Crohn's disease in children has a course more aggressive than in adults; therefore it requires equally aggressive therapy early.
    La malattia di Crohn nel bambino ha un decorso pi¿ aggressivo che nell¿adulto; pertanto necessita di terapia altrettanto aggressive precocemente.
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10042759
    E.1.2Term Symptoms involving digestive system
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the effectiveness of weekly subcutaneously administered MTX for maintaining relapse-free sustained steroid/EN-free 1-year
    remission compared with:
    ¿ daily oral AZA/6MP in low risk paediatric CD
    ¿ subcutaneously administered adalimumab in high risk paediatric CD
    Paragonare l¿efficacia della somministrazione settimanale sottocutanea del Methotrexate nel mantenimento dello stato di remissione libero da ricadute per almeno un anno senza impiego di steroidi o nutrizione enterale con:
    -Somministrazione orale giornaliera di Azatioprina/6Mercaptopurina in pazienti pediatrici con Malatita di Crohn a basso rischio
    -Somministrazione sottocutanea di Adalimumab in pazienti pediatrici con Malattia di Crohn ad alto rischio
    E.2.2Secondary objectives of the trial
    Comparison between the two treatment arms per risk group (high risk or
    low risk for aggressive disease evolution) (and inter-risk group analysis for MTX-
    treated patients)
    Paragonare i due bracci di trattamento stratificati per classi di rischio (alto rischio o basso rischio per evoluzione aggressiva di malattia)(ed analisi tra i gruppi di rischio per i pazienti trattati con Methotrexate).

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria

    - Children 6-17, with a new-onset CD diagnosed according to established criteria, requiring a steroid-based or EN based induction therapy
    2. At initial diagnosis, wPCDAI >40
    3. all wPCDAI scores (0-120) are possible at inclusion (patients in remission and patients with active disease)
    4. Luminal active CD (B1) with or without B2 and/or B3 disease behavior
    5. Initial exposure to 5-ASA and derivate is tolerated
    6. Exposure to antibiotics is tolerated
    7. No evidence of active or latent TB ie,
    i) A negative QuantiFERON TB-Gold In-Tube test at screening, AND
    ii) A chest radiograph (views as per local guidelines) taken at screening or within the 3 months prior to screening (with the report or films available for investigator review) without evidence of active or latent TB infection, AND
    iii) No history of either untreated or inadequately treated latent or active TB infection
    b) Previously treated for TB: i.e., if a subject has previously received an adequate course of therapy as per local standard of care for either latent TB or active TB. In these cases, no QuantiFERON TB-Gold In-Tube test (or equivalent assay) need be obtained, but a chest radiograph must be obtained if not done so within 3 months prior to screening.
    8. If one of the following criteria is present, patients are allocated to the high risk group prior randomization:
    • Complex fistulizing perianal disease
    • Panenteric disease phenotype
    • Severe growth impairment (height z-score <-2 percentiles) likely related to CD
    • Significant hypoalbuminemia (12.5 despite 3 weeks of optimized induction therapy with steroids or EEN
    • B2, B3 or B2B3 disease behavior
    • Overall cumulative disease extend of =60 cm 8.
    9. Informed and signed consent
    - Bambini di età compresa tra 6 e 17 anni con nuova diagnosi di MC secondo i criteri riconosciuti, in trattamento con terapia di induzione con corticosteroidi o Nutrizione Enterale.
    - Alla diagnosi malattia attiva (wPCDAI>40)
    - Tutti i wPCDAI score (0-120) sono possibili al momento dell’inclusione
    - MC e attiva a livello luminale con o senza presentazione di tipo B2 e/o B3.
    - Concesso l’iniziale impiego di 5-ASA e derivati e l’esposizione ad antibiotici
    - - Esclusa una infezione da Mycobacterium tubercolosis, ovvero:
    a.Nessuna evidenza di tubercolosi attiva o latente,
    b. Test QuantiFERON® TB Gold negativo al momento dello screening
    c. Radiografia del torace alla visita di screening o entro i 3 mesi prima dello screening senza evidenza di infezione da TBC attiva o latente
    d. Nessun precedente di una infezione da TB latente o attiva non trattata o non
    adeguatamente trattata
    - In caso di soggetti precedentemente trattati per la tubercolosi, oltre al test QuantiFERON® TB Gold negativo alla visita di screening, deve essere documentata una radiografia del torace negativa, entro non oltre 3 mesi prima dello screening
    - In caso di pazienti nei quali viene riscontrata una TB latente durante lo screening (definita come un test QuantiFERON TB Gold in provetta [o test equivalente] positivo) in cui la tubercolosi attiva è stato esclusa, è possibile l’arruolamento solo se il trattamento profilattico per la TB è stato avviato per un minimo di 4 settimane prima della prima somministrazione del farmaco in studio.
    Se uno dei seguenti criteri è presente il paziente viene allocato nel gruppo ad “alto rischio”:
    1. Malattia perianale complessa
    2. Malattia panenterica
    3. Severo ritardo di crescita (height z-score <2) verosimilmente dovuto alla MC
    4. Ipoalbuminemia significativa (<30g/L) elevata PCR (valori> ad almeno 2 volte la norma) o wPCDAI>12.5 nonostante 3 settimane di terapia di induzione ottimizzata con steroidi o nutrizione enterale
    5. Malattia complicata (B2,B3 o B2B3)
    6. estensione di malattia complessivamente >60 cm
    - Accettazione della partecipazione allo studio con firma del consenso informato
    E.4Principal exclusion criteria
    1. Patients with wPCDAI<42,5 at initial diagnosis
    2. No induction therapy with steroids or enteral nutrition
    3. Previous therapy with any IBD-related medications other than induction therapy
    as detailed in this protocol (except 5-ASA).
    4. Pregnancy or refusal to use contraceptives during the study period in pubertal
    patients (both boys and girls) unless absolute abstinence (no sexual activity) is
    confirmed at each study visit. Positive pregnancy testing throughout the study will
    trigger prompt withdrawal of the patient from the study.
    5. Lactating mothers
    6. Children with perianal fistulising disease who require surgical therapy (drainage,
    seton placement)
    7. Patients homozygous for TPMT or those with TPMT activity <6 nmol/h/ml
    erythrocytes or <9nmol 6MTG/g Hb/h), unless they qualify as high risk patients
    8. Evidence of un-drained and un-controlled abscess/phlegmon
    9. Contraindication to any drugs used in the trial (thiopurines, methotrexate or adalimumab)
    10. Current or previous malignancy
    11. Serious comorbidities (such as renal insufficiency, hepatitis, respiratory
    insufficiency)
    12. patients with suspected of sepsis, cytomegalovirus infection, listeriosis and other opportunistic infections
    12. Infection with mycobacterium tuberculosis, hepatitis B or C, HIV
    13. Moderate to severe heart failure (NYHA class III/IV)
    14. Oral anticoagulant therapy, anti-malaria therapy
    15. Live vaccines exposure (including yellow fever) less than 3 weeks prior inclusion
    -Pazienti con wPCDAI<42,5 alla diagnosi
    - Pazienti non trattati con steroidi o nutrizione enterale per l’induzione della remissione
    - Precedente terapia con altri farmaci impiegati per IBD diversi da quelli precedenti (accetto 5-ASA)
    - Gravidanza o rifiuto di usare i contraccettivi durante il periodo di studio in pazienti in età puberale (maschi e femmine) a meno che l'astinenza assoluta (nessuna attività sessuale) sia confermata ad ogni visita di studio. Un test di gravidanza positivo nel corso dello studio determinerà il ritiro del paziente dallo studio.
    - Donne in allattamento
    - Bambini con malattia anale fistolizzante che richiede prevalentemente trattamento della malattia perianale e malattia non luminale
    - Pazienti in omozigosi per TPMT (o con attività TPMT molto bassa: <6 nmol/h/ml eritrociti o <9nmol 6MTG/g Hb/h)
    - Evidenza di ascessi o flemmoni non drenati
    Controindicazioni per uno dei farmaci usati nel trial (adalimumab, methotrexate o azatioprina)
    - Attuali o precedenti tumori
    - - Serie comorbidità (come insufficienza renale, epatite, insufficienza respiratoria) che possano interferire con la terapia medica
    - Infezione attiva da Mycobacterium tubercolosis
    - Pazienti con sospetta sepsi, infezione da cytomegalovirus, listeriosi o altre infezioni da agenti opportunisti
    - Pazienti HIV, HCV e HBV
    - Insufficienza cardiaca moderata-severa (classe NYHA III/IV)
    - Terapia anticoagulante orale o anti-amalaria
    - Esposizione a vaccini vivi nelle 3 settimane precedenti all’ingresso nello studio
    E.5 End points
    E.5.1Primary end point(s)
    Comparing the two treatment arms per group
    for sustained steroid/EN-free remission at Month 12, where sustained remission is defined as wPCDAI S12.5 and CRP S1,5-fold upper limit
    without a relapse or need for EEN/steroids since week 12.
    Paragonare l’efficacia dei due gruppi di trattamento per gruppo nel mantenimento di una remissione prolungata a 12 mesi senza ricorso a terapia steroidea e/o nutrizione enterale, dove per remissione prolungata si intende un wPCDAI=12.5 e una PCR=1,5 volte il limite massimo senza recidive o bisogno di steroidi/nutrizione enterale dalla settimana 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    At months 12
    12 mesi
    E.5.2Secondary end point(s)
    Comparing the 2 treatment arms per risk group and comparing methotrexate treatment between high and low risk group
    Paragonare i due gruppi di trattamento stratificati per rischio di malattia severa e valutare l¿efficacia del methotrexate nei pazienti ad ad alto e basso rischio di malattia severa.

    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months
    12 mesi
    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 No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Assicurare il cieco in un secondo medico che valuter¿ il wPCDAI, PCDAI e PGA ad ogni visita
    To ensure blinding of a 2nd physician who scores wPCDAI, PCDAI & PGA at each visit
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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
    Belgium
    France
    Germany
    Hungary
    Italy
    Netherlands
    Poland
    United Kingdom
    Czechia
    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
    At the end of enrolement, treatment and monitoring
    Fine del periodo di arruolamento, trattamento e monitoraggio
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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 Yes
    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: 156
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 156
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state26
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 312
    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)
    patient will be followed as per the regular treatment of their disease.
    I pazienti continueranno ad essere seguiti regolarmente per le esigenze legate alla loro patologia
    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 Decision2017-02-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-15
    P. End of Trial
    P.End of Trial StatusOngoing
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