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    Summary
    EudraCT Number:2011-004914-40
    Sponsor's Protocol Code Number:A3921103
    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:2012-09-21
    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 number2011-004914-40
    A.3Full title of the trial
    AN OPEN-LABEL MULTIPLE DOSE STUDY TO EVALUATE THE
    PHARMACOKINETICS, SAFETY AND TOLERABILITY OF CP-690,550 IN
    PEDIATRIC PATIENTS FROM 2 TO LESS THAN 18 YEARS OF AGE WITH
    JUVENILE IDIOPATHIC ARTHRITIS (JIA)
    STUDIO IN APERTO CON SOMMINISTRAZIONE DI DOSI MULTIPLE PER VALUTARE LA FARMACOCINETICA, SICUREZZA E TOLLERABILITA’ DI CP-690,550 IN PAZIENTI PEDIATRICI DI ETA’ COMPRESA TRA 2 E 18 ANNI NON COMPIUTI CON ARTRITE IDIOPATICA GIOVANILE (AIG)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 1 Study to Characterize the Pharmacokinetics of CP-690,550 in Pediatric JIA Patients aged 2-18
    Studio di fase 1 per valutare la farmacocinetica di CP-690,550 in pazienti pediatrici con AIG di eta' compresa tra 2-18 anni
    A.4.1Sponsor's protocol code numberA3921103
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01513902
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/162/2011
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPFIZER INC.
    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 supportPfizer Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc.
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number001 800 718021
    B.5.5Fax number001 303 7391119
    B.5.6E-mailclinicaltrials.govcallcenter@pfizer.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 nameTofacitinib
    D.3.2Product code CP-690,550-10
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTofacitinib
    D.3.9.1CAS number 540737-29-9
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.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 nameTofacitinib
    D.3.2Product code CP-690,550-10
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTofacitinib
    D.3.9.1CAS number 540737-29-9
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    JUVENILE IDIOPATHIC ARTHRITIS
    ARTRITE IDIOPATICA GIOVANILE
    E.1.1.1Medical condition in easily understood language
    JUVENILE IDIOPATHIC ARTHRITIS
    ARTRITE IDIOPATICA GIOVANILE
    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 15.0
    E.1.2Level SOC
    E.1.2Classification code 10028395
    E.1.2Term Musculoskeletal and connective tissue disorders
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10059176
    E.1.2Term Juvenile idiopathic arthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue 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 characterize the pharmacokinetics (PK) and safety of CP-690,550 following multiple oral doses in pediatric patients (from 2 to less than 18 years) with active JIA.
    o Caratterizzare le proprietà farmacocinetiche (PK) e la sicurezza di CP-690,550 in seguito a somministrazione di dosi orali multiple in pazienti pediatrici (di età compresa tra 2 e 18 anni non compiuti) con AIG in fase attiva.
    E.2.2Secondary objectives of the trial
    To evaluate taste acceptability of the oral formulation of CP-690,550 in pediatric patients with JIA.
    o Valutare la gradevolezza,in termini di gusto,della formulazione orale di CP-690,550 nei pazienti pediatrici con AIG.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study: Pediatric patients with JIA aged from 2 to less than 18 years with active JIA (extended oligoarthritis, polyarthritis rheumatoid factor positive or negative, psoriatic arthritis,enthesitis related arthritis), in 5 or more joints (using ACR definition of active joint) at the time of the first study drug administration. 1. The patient has discontinued prohibited concomitant medications for the required time prior to the first dose of study drug, as defined in Appendix 4, and is taking only those concomitant medications in doses and frequency allowed by the protocol. 2. Fertility: a. Sterile male, or non sterile male. If the patient is a non sterile male receiving MTX treatment and is sexually active with a female partner of child-bearing potential, he and his partner must be using an acceptable method of contraception during the study, and after therapy for the duration according to the local drug label. b. Females of childbearing potential must be using an acceptable method of contraception (abstinence being a possible option) starting at least 14 days prior to the first dose of study drug and continuing for at least one ovulatory cycle after the last dose of study drug. 3. For patients receiving MTX treatment, minimum duration of therapy is 4 months and dose stable for at least 6 weeks prior to first dose of study drug. MTX may be administered either orally or parenterally at doses up to the lesser of 20 mg/wk or 15 mg/m2/week. 4. A negative QuantiFERON-TB Gold In-Tube test6 performed within the 3 months prior to screening. A negative PPD test can be substituted for the QuantiFERON-TB Gold In-Tube test only if the central laboratory is unable to perform the test or cannot determine the results to be positive or negative and the Pfizer medical monitor approves it, on a case-by-case basis. 5. Written informed consent for study participation obtained from parents or legal guardian, with assent as appropriate by the patient, depending on the level of the patient’s understanding. 6. Patients who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
    Per essere considerati idonei all’arruolamento, i soggetti dovranno soddisfare tutti i seguenti criteri d’inclusione: Pazienti pediatrici con AIG, di età compresa tra 2 anni a 18 anni non compiuti, con AIG in fase attiva (oligoartrite estesa, poliartrite positiva o negativa per il fattore reumatoide, artrite psoriasica, artrite correlata ad entesite) in 5 o più articolazioni (utilizzando la definizione ACR di articolazione attiva) al momento della prima somministrazione del farmaco in studio. 1. Il paziente ha sospeso l’assunzione di farmaci concomitanti vietati per il tempo previsto prima della prima dose di farmaci in studio, secondo quanto riportato in Appendice 4, ed assume esclusivamente i farmaci concomitanti alla dose e alla frequenza consentite dal protocollo. 2. Fertilità: a. Soggetti di sesso maschile sterili o non sterili. Se il paziente è un soggetto di sesso maschile non sterile trattato con MTX ed è sessualmente attivo con una partner potenzialmente fertile, sia il paziente che la partner sono tenuti ad utilizzare un metodo contraccettivo approvato nel corso dello studio e dopo la fine della terapia per il periodo indicato nella scheda tecnica locale del prodotto. b. Le pazienti potenzialmente fertili devono utilizzare un metodo contraccettivo approvato (l’astinenza rappresenta una delle opzioni possibili) a partire da almeno 14 giorni prima della prima dose di farmaco in studio e continuando per almeno un ciclo ovulatorio dopo l’ultima dose di farmaco in studio. 3. Per i pazienti che ricevono il trattamento con MTX, la durata minima della terapia è di 4 mesi e la dose deve essere stabile da almeno 6 settimane prima dell’assunzione della prima dose di farmaco in studio. La somministrazione di MTX può avvenire sia per via orale che parenterale fino al raggiungimento della dose più bassa tra 20 mg/settimana e 15 mg/m2/settimana. 4. Negatività al test QuantiFERON-TB Gold In-Tube6 da eseguire nei 3 mesi precedenti lo screening. In alternativa, è accettabile la negatività al test PPD invece del QuantiFERON-TB Gold In-Tube solo nei casi in cui il laboratorio centralizzato non sia in grado di eseguire tale esame o non possa stabilire se i risultati siano positivi o negativi, e previa approvazione da parte del monitor medico di Pfizer, che effettuerà la sua valutazione caso per caso. 5. Consenso informato scritto per la partecipazione allo studio da parte dei genitori o del tutore legale, con l’eventuale assenso del paziente a seconda del livello di comprensione dello stesso. 6. Pazienti che sono intenzionati e in grado di rispettare le visite programmate, il piano di trattamento, gli esami di laboratorio e le altre procedure dello studio.
    E.4Principal exclusion criteria
    Patients presenting with any of the following will not be included in the study: 1. Systemic JIA, persistent oligoarthritis, and undifferentiated arthritis. 2. Blood dyscrasias, including: a. Hgb <11 g/dL or Hct <33%.b. WBC <3.0 x 109/L. c. Neutrophil count <1.2 x 109/L. d. Platelet count <100 x 109/L. 3. Estimated GFR <40 mL/min calculated using the Schwartz formula (Appendix 3) at the Screening Visit. 4. Current or recent history of uncontrolled clinically significant renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, or neurological disease. 5. AST or ALT >/-1.5 times the upper limit of normal or any other clinically significant laboratory abnormality. 6. History of any other rheumatic autoimmune disease. 7. History or current symptoms suggestive of any lymphoproliferative disorder, such as Epstein Barr Virus (EBV) related lymphoproliferative disorder, history of lymphoma, leukemia, or signs and symptoms suggestive of current lymphatic disease. 8. Infections: a. Latent or active TB or any history of previous TB. b. Chronic infections. c. Any infection requiring hospitalization, parenteral antimicrobial therapy or judged to be opportunistic by the investigator within the 6 months prior to the first dose of study drug. d. Any treated infections within 2 weeks. e. A patient known to be infected with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus. f. History of infected joint prosthesis with prosthesis still in situ. 9. History of recurrent (more than one episode) herpes zoster or disseminated (a single episode) herpes zoster or disseminated (a single episode) herpes simplex. 10. Any condition possibly affecting drug absorption (eg, gastrectomy). 11. Patients taking potent and moderate CYP3A4 inhibitors (Appendix 4). 12. Patients taking potent and moderate CYP3A4 inducers (Appendix 4). 13. The following biologic agents and DMARDs are disallowed at any time during this study. If a patient needs to be treated with one of these agents, the patient should be discontinued from the study:  Anakinra (Kineret) and etanercept (Enbrel) must be discontinued for 4 weeks prior to first dose of study drug;  Adalimumab (Humira) must be discontinued for 6 weeks prior to first dose of study drug;  Infliximab (Remicade) must be discontinued for 8 weeks prior to first dose of study drug;  Golimumab (Simponi TM) must be discontinued for 10 weeks prior to first dose of study drug;  Abatacept (Orencia), tocilizumab (Actemra) and certolizumab pegol (Cimzia) must be discontinued for 12 weeks prior to first dose of study drug;  Auranofin (oral gold), aurothioglucose (injectable gold), aurothiomalate (injectable gold) must be discontinued for 8 weeks prior to first dose of study drug;  Leflunomide (Arava) must be discontinued 8 weeks prior to first dose of study drug. Alternatively, a washout procedure using cholestyramine may be performed (eg, 240 mg/kg/24 hr divided TID, not to exceed 8 g/24 hours for 11 days. Cholestyramine to be given in a slurry in water, juice, or milk before meals for tolerability);  Sulfasalazine, d-penicillamine, azathioprine, chloroquine, hydroxychloroquine, cyclosporine, tacrolimus, and staphylococcal protein A immuno-absorbant pheresis columns (eg, PROSORBA device/column) must be discontinued for 4 weeks prior to first dose of study drug.
    I pazienti che presenteranno una qualunque delle seguenti condizioni verranno esclusi dallo studio: 1. AIG sistemica, oligoartrite persistente e artrite indifferenziata. 2. Discrasie ematiche, quali: a. Hgb &lt;11 g/dl o Hct &lt;33%. b. WBC &lt;3,0 x 109/l. c. Conta dei neutrofili &lt;1,2 x 109/l. d. Conta piastrinica &lt;100 x 109/l. 3. GFR stimato &lt;40 ml/min, calcolato con la formula di Schwartz (Appendice 3) alla visita di Screening. 4. Storia attuale o recente di malattia renale, epatica, ematologica, gastrointestinale, endocrina, polmonare, cardiaca o neurologica non controllata e clinicamente significativa. 5. Valori di AST o ALT ≥1,5 volte il limite superiore della norma, oppure qualunque altra anomalia clinicamente significativa dei parametri di laboratorio. 6. Presenza all’anamnesi di qualunque altra patologia autoimmune reumatica. 7. Storia o presenza attuale di sintomi indicativi di un disordine linfoproliferativo, come il disordine linfoproliferativo correlato al virus di Epstein Barr (EBV), storia di linfoma, leucemia o segni e sintomi che suggeriscano la presenza di una malattia linfatica in corso. 8. Infezioni: a. TB in fase latente o attiva, oppure storia di TB pregressa. b. Infezioni croniche. c. Qualunque infezione che richieda ospedalizzazione, terapia antimicrobica per via parenterale o che sia giudicata di tipo opportunistico dallo sperimentatore nei 6 mesi precedenti la prima assunzione del farmaco in studio. d. Presenza di qualsiasi infezione trattata nelle 2 settimane precedenti. e. Infezione accertata con il virus dell’immunodeficienza umana (HIV), con il virus dell’epatite B o con quello dell’epatite C. f. Storia di protesi articolare infetta con presenza attuale della protesi in situ. 9. Storia di herpes zoster ricorrente (più di un episodio) o disseminato (episodio singolo) o di herpes simplex disseminato (episodio singolo). 10. Qualunque condizione che potrebbe influire sull’assorbimento del farmaco (es. gastrectomia). 11. Pazienti che assumono inibitori potenti e moderati del CYP3A4 (Appendice 4). 12. Pazienti che assumono induttori potenti e moderati del CYP3A4 (Appendice 4). 13. I seguenti farmaci biologici e DMARD non sono ammessi in nessun momento dello studio. Qualora un paziente abbia necessità di assumere uno di tali farmaci, dovrà essere ritirato dallo studio: o Anakinra (Kineret) ed etanercept (Enbrel) dovranno essere sospesi 4 settimane prima dell’assunzione della prima dose di farmaco in studio; o Adalimumab (Humira) dovrà essere sospeso 6 settimane prima dell’assunzione della prima dose di farmaco in studio; o Infliximab (Remicade) dovrà essere sospeso 8 settimane prima dell’assunzione della prima dose di farmaco in studio; o Golimumab (SimponiTM) dovrà essere sospeso 10 settimane prima dell’assunzione della prima dose di farmaco in studio; o Abatacept (Orencia), tocilizumab (Actemra) e certolizumab pegol (Cimzia) dovranno essere sospesi 12 settimane prima dell’assunzione della prima dose di farmaco in studio; o Auranofina (sale d’oro per via orale), aurotioglucosio (sale d’oro per via iniettabile) ed aurotiomalato (sale d’oro per via iniettabile) dovranno essere sospesi 8 settimane prima dell’assunzione della prima dose di farmaco in studio; o Leflunomide (Arava) dovrà essere sospeso 8 settimane prima dell’assunzione della prima dose di farmaco in studio. In alternativa, è possibile eseguire una procedura di washout utilizzando la colestiramina (es. 240 mg/kg/24 ore in dosi refratte TID, senza superare 8 g/24 ore per 11 giorni. La colestiramina deve essere sciolta in acqua, succo o latte prima dei pasti per questioni di tollerabilità); o Sulfasalazina, d-penicillamina, azatioprina, clorochina, idrossiclorochina, ciclosporina, tacrolimus e colonne per aferesi di immunoassorbimento con proteina A stafilococcica es.disp/colonna PROSORBA dovranno essere sospesi 4 sett. prim
    E.5 End points
    E.5.1Primary end point(s)
     Oral clearance (CL/F) on Day 5.
     Safety and tolerability.
    o Clearance orale (CL/F) valutata al Giorno 5.
    o Sicurezza e tollerabilità
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline/Day 1 and Day 5
    Basale/Giorno 1 e Giorno 5
    E.5.2Secondary end point(s)
    Area under the plasma concentration-time profile over the dosing interval τ, at steady
    state (AUC), maximum plasma concentration (Cmax), Time for Cmax (tmax), apparent
    volume of distribution (Vz/F), and terminal elimination half-life (t1/2).
     Evaluation of taste acceptability of oral formulation.
    o Profilo dell’area sotto la curva concentrazione plasmatica/tempo nell’intervallo τ tra una somministrazione e l’altra allo steady state (AUCτ), concentrazione plasmatica massima (Cmax), Tempo al raggiungimento del Cmax (tmax), volume apparente di distribuzione (Vz/F) ed emivita di eliminazione terminale (t1/2).
    o Valutazione della gradevolezza, in termini di gusto, della formulazione orale.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline/Day 1 and Day 5
    Basale/Giorno 1 e Giorno 5
    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 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 Yes
    E.6.13.1Other scope of the trial description
    tolerability
    tollerabilità
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Characterize the pharmacokinetics of CP-690,550 in Pediatric Patients
    Caratterizzare farmacocinetica di CP-690,550 in pazienti pediatrici
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial0
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    Mexico
    Russian Federation
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months15
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months15
    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: 24
    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: 16
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 8
    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
    Minors incapable of giving informed consent
    minori non in grado di dare il consenso
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 18
    F.4.2.2In the whole clinical trial 24
    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)
    Subjects will be eligible to enrol into A3921145, long term efficacy study
    I soggetti potranno essere arruolati nello studio A3921145, studio di efficacia a lungo termine
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation PRINTO
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-11-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-24
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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