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    Summary
    EudraCT Number:2011-001240-29
    Sponsor's Protocol Code Number:C25002
    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:2012-04-03
    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 number2011-001240-29
    A.3Full title of the trial
    A Phase 1/2 Study of brentuximab vedotin (SGN-35) in Pediatric Patients With Relapsed or Refractory Systemic Anaplastic Large-Cell Lymphoma or Hodgkin Lymphoma
    Studio di fase 1/2 su brentuximab vedotin (SGN-35) in pazienti pediatrici con linfoma a grandi cellule anaplastico sistemico o linfoma di Hodgkin recidivo o refrattario
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Brentuximab Vedotin in Children and Adolescents With Relapsed or Refractory Systemic Anaplastic Large-Cell Lymphoma or Hodgkin Lymphoma
    Studio su vedotin brentuximab in bambini e adolescenti con linfoma a grandi cellule anaplastico sistemico o linfoma di Hodgkin recidivo o refrattario
    A.4.1Sponsor's protocol code numberC25002
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/059/2011
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMILLENNIUM PHARMACEUTICALS, 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 supportMillenium Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMillenium Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointJeanenne Chung (PM)
    B.5.3 Address:
    B.5.3.1Street Address40 Landsdowne Street
    B.5.3.2Town/ cityCambridge, MA
    B.5.3.3Post code02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1 617 4443331
    B.5.5Fax number+1 617 4442399
    B.5.6E-mailjeanenne.chung@mpi.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 nameBrentuximab vedotin
    D.3.2Product code SGN-35
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBrentuximab vedotin
    D.3.9.1CAS number 914088-09-8
    D.3.9.2Current sponsor codeSGN-35
    D.3.9.3Other descriptive nameSGN-35
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    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) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relapsed or Refractory Systemic Anaplastic Large-Cell Lymphoma or Hodgkin Lymphoma
    Linfoma a grandi cellule anaplastico sistemico o linfoma di Hodgkin recidivo o refrattario
    E.1.1.1Medical condition in easily understood language
    Rare blood cancer requiring treatment
    Tumore raro del sangue che richiede trattamento
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase 1: •To assess the safety profile and determine the pediatric maximum tolerated dose and/or recommended phase 2 dose of brentuximab vedotin •To assess the pharmacokinetics of brentuximab vedotin Phase 2: •To determine the overall response rate (complete remission, partial remission) with brentuximab vedotin at the recommended phase 2 dose
    Obiettivo principale: Fase I °per stabilire il profilo di sicurezza e determinare la dose massima pediatrica tollerata e/o la fase II raccomandata di brentuximab vedotin °Stabilire la farmacocinetica di brentuximab vedotin Fase II: °Determinare il tasso complessivo di risposta (remissione completa, remissione parziale), con vedotin brentuximab alla dose raccomandata di fase 2
    E.2.2Secondary objectives of the trial
    Phase 1: •To determine the immunogenicity of brentuximab vedotin •To determine the overall response rate (complete remission, partial remission) with brentuximab vedotin •To determine the time to progression, time to response, duration of response, and event-free, progression-free, and overall survival with brentuximab vedotin Phase 2: •To determine the time to progression, time to response, duration of response, and event-free, progression-free, and overall survival with brentuximab vedotin •To assess the pharmacokinetics and safety profile of brentuximab vedotin •To determine the immunogenicity of brentuximab vedotin
    Fase I ° determinare l'immunogenicità di brentuximab vedotin °determinare il tasso complessivo di risposta (remissione completa, remissione parziale) con brentuximab vedotin °determinare il tempo di progressione, tempo di risposta, durata della risposta, e libero da evento, libero da progressione, e sopravvivenza globale con brentuximab vedotin °stabilire la farmacocinetica e il profilo di sicurezza di brentuximab vedotin °determinare l’immunogenicità di brentuximab vedotin
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients aged 2 to < 18 years (5 to < 18 years for patients with HL). 2. Have a diagnosis of systemic anaplastic large-cell lymphoma, or Hodgkin lymphoma for which standard, curative, life-prolonging, or palliative treatment does not exist or is no longer effective. (Patients diagnosed with any relapsed or refractory CD30+ hematological malignancy [eg, primary mediastinal B-cell lymphoma] may be included in phase 1 of the study.) 3. Patients with sALCL must have documented anaplastic lymphoma kinase (ALK) status. 4. Patients with HL must be in their second or later relapse, have failed systemic chemotherapy either as induction therapy for advanced stage disease or salvage therapy, and were ineligible for, refused, or previously received a stem cell transplant. 5. Patients with relapsed or refractory sALCL must be beyond first remission or refractory to front-line chemotherapy. 6. Performance score ≥ 60 from Lansky Play Performance Scale if ≤ 16 years 7. Female patients who: • Are postmenopausal for at least 1 year before the screening visit, OR • Are surgically sterile, OR • If they are of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form (ICF) through 6 months after the last dose of study drug, or agree to completely abstain from heterosexual intercourse Male patients, even if surgically sterile, who: • Agree to practice effective barrier contraception during the entire study treatment period and through 6 months after the last dose of study drug, OR • Agree to completely abstain from heterosexual intercourse 8. Voluntary written consent (and institution-specific assent as appropriate based upon patient comprehension) must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent/assent may be withdrawn by the patient or patient guardian at any time without prejudice to future medical care. 9. Suitable venous access for the study-required procedures. 10. Clinical laboratory values as specified below within 14 days before the first dose of study drug: • Absolute neutrophil count greater than or equal to 1,500/μL. • Platelet count greater than or equal to 75,000/μL. • Serum bilirubin level less than or equal to 1.5 x upper limits of normal (ULN). • Serum creatinine less than or equal to 1.5 x ULN. • Alanine aminotransferase (ALT or SGPT) and aspartate aminotransferase (AST or SGOT) less than or equal to 2.5 x ULN. 11. Patients must have a radiographically or clinically evaluable tumor per the IWG(1) criteria.
    1.Maschi o femmine di età compresa tra i 2 e i 18 anni (da 5 ai 18 anni per pazienti con linfoma di Hodgkin). 2.Avere una diagnosi di linfoma a grandi cellule anaplastico sistemico o linfoma di Hodgkin, recidivo o refrattario per il quale il trattamento standard, curativo, prolungativo della vita, o palliativo non esiste o non ha più effetto.(I pazienti con una diagnosi CD30+ malattia ematologica recidiva o refrattaria [ad es. Linfoma primitivo al mediastino cellule B] devono essere inclusi nella fase I dello studio. 3.Pazienti con sALCL devono avere una documentazione di stato di chinasi linfoma anaplastico 4.Pazienti con linfoma di Hodgkin devono essere alla loro seconda o successiva ricaduta, devono aver hanno fallito la chemioterapia sistemica sia come induzione di terapia per la malattia in fase avanzata o la terapia di salvataggio, e non sono eleggibili per o hanno rifiutato , o hanno ricevuto in precedenza un trapianto di cellule staminali. 5.I pazienti con recidiva o refrattaria sALCL deve essere al di là della prima remissione o refrattario al front-line chemioterapico 6.Avere un punteggio 60 della Lansky Play Performance Scale se  16 anni 7.Le pazienti femmine che: Sono chirurgicamente sterili O Se sono potenzialmente fertili, devono accettare di praticare due metodi di contraccezione effettivi, allo stesso tempo, dal momento in cui hanno firmato il consenso informato sino ai sei mesi successivi all’ultima dose del farmaco in studio, o essere d’accordo di astenersi completamente da relazioni eterosessuali. Pazienti maschi, anche se chirurgicamente sterili, devono: Accettare di praticare una contraccezione a barriera durante tutta la durata dello studio e dopo i sei mesi successivi all’ultima dose del farmaco in studio O Decidere di astenersi completamente da rapporti eterosessuali 8.Dare volontariamente il proprio consenso (e lo specifico assenso sulla base della comprensione del paziente) deve essere effettuata una prima esecuzione di qualsiasi procedura di studio non riferibile alle cure mediche standard, con la comprensione che il consenso / assenso può essere ritirato dal paziente o del tutore del paziente in qualunque momento senza pregiudicare le cure mediche future 9.Avere un accesso venoso adatto alle procedure dello studio 10.Avere valori di laboratorio clinicamente accettabili come specificato in seguito, entro 14 giorni prima della prima dose dello studio: Conta assoluta dei neutrofili più grande o uguale a 1500/µL. Conta piastrinica più grande o uguale a 75,000/µL. Livello di siero bilirubina minore o uguale a 1.5 ai limiti superiori o normali (ULN) Creatinina siero minore o uguale a 1.5 x ULN. Alanina aminotransferasi (ALT o SGPT) e aspartate aminotransferasi (AST o SGOT) minore o uguale a 2.5 x ULN. 11.I pazienti devono avere un tumore valutabile per criterio IWG(1) radiografico o clinico
    E.4Principal exclusion criteria
    1. Current diagnosis of primary cutaneous ALCL (those with systemic ALCL are eligible). 2. Received an allogeneic stem cell transplant < 1 year prior to first dose of study medication, or presence of polymerase chain reaction (PCR)-detectable CMV in any post-allogeneic transplant patient. (Prior PCR positivity that was successfully treated is acceptable provided the baseline PCR result is negative prior to first dose of study drug.) 3. Receiving immunosuppressive therapy. 4. Receiving systemic therapy for chronic graft-versus-host disease (topical therapy is allowed). 5. Previous treatment with any anti-CD30 antibody. 6. Therapeutic monoclonal antibody use within the longer of 6 weeks or 5 plasma half-lives. 7. Symptomatic cardiac disease including ventricular dysfunction, coronary artery disease, or arrhythmias, if this would, in the opinion of the investigator or medical monitor, interfere with assessment of efficacy or safety of the drug. 8. History of another primary malignancy not in remission for at least 3 years. (The following are exempt from the 3-year limit: nonmelanoma skin cancer and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Pap smear) 9. Known cerebral/meningeal disease. 10. History of cirrhosis. 11. Active systemic viral, bacterial, or fungal infection requiring antimicrobial, antiviral therapy or antifungal therapy within 2 weeks prior to first dose of study drug (routine antimicrobial prophylaxis is acceptable). 12. Concurrent therapy with other anti-neoplastic or experimental agents. 13. Concurrent corticosteroid therapy at greater than or equal to 0.5 mg/kg or 10 mg/day prednisone. 14. Any serious underlying medical condition that, in the opinion of the investigator or medical monitor, would impair their ability to receive or tolerate the planned treatment. 15. Known hypersensitivity to recombinant proteins, murine proteins, or any excipient contained in the drug formulation. 16. Received nitrogen mustard agents, melphalan, or BCNU therapy within 6 weeks prior to first study dose. 17. Prior autologous hematopoietic stem cell infusion < 8 weeks prior to first study dose. 18. Grade 2 or greater unresolved toxicity from prior antineoplastic therapy. 19. Received a strong inhibitor of CYP3A4 < 2 weeks prior to first study dose.
    1.Diagnosi corrente di ALCL cutaneo primario (coloro che hanno un ALCL sistemico sono eleggibili) 2.Aver ricevuto un trapianto di cellule staminali allogeniche&gt; 1 anno prima della prima dose del farmaco in studio, o la presenza di reazione a catena della polimerasi (PCR)- CMW rilevabile in ogni post-trapianto allo enico. (Precedente PCR positiva che sia stata trattata con successo è accettabile, sempre che chela PCR al basale sia negativa prima dell’inizio della prima dose) 3.Ricevere terapia immunosoppressiva 4.Ricevere una terapia sistemica per Graft versus host disease (la terapia topica è consentita). 5.Trattamento precedente con qualsiasi anti-CD 30 anticorpo. 6.Anticorpo terapeutico monoclonale utilizzato al più per 6 settimane o 5 emivite plasmatiche. 7.Malattia cardiaca sintomaticaincluso disfunzioni ventricolari, malattia coronarica, o aritmia, se questo possa, secondo l’opinione dello sperimentatore o medical monitor, interferire con la valutazione di efficacia o di sicurezza del farmaco 8.Storia di un altro tumore primario maligno non in remissione per almeno 3 anni ( i seguenti sono esenti dal limite dei tre anni: nonmelanoma cancro alla pelle e carcinoma cervicale in situ alla biopsia o Lesione squamosa intraepiteliale al Pap-test) 9.Riconosciuta malattia celebrale o meningite 10.Storia di cirrosi 11.Infezione attiva sistemica virale, batterica o fungo che necessitino di antimicrobici, terapia antivirale o fungicida entro due settimane prima della prima dose di farmaco in studio (la profilassi per la terapia antimicrobica è accettabile). 12.Terapia concomitante con altri anti-neoplastici o agenti sperimentali 13.Terapia corticosteroidale maggiore o uguale a 0.5 mg/kg o 10 mg/giorno prednisone. 14.Qualsiasi seria condizione medica di base che, a giudizio del ricercatore o del monitor medica, possano pregiudicare la loro capacità di ricevere o di tollerare il trattamento previsto. 15.Ipersensibilità nota alle proteine ricombinanti, alle proteine murine o qualsiasi eccipiente contenuto nella formulazione dei farmaci. 16.Aver ricevuto agenti azotate vescicanti, melfalan, o la terapia BCNU entro 6 settimane prima dalla prima dose in studio. 17.Prima infusione autologa di cellule staminali ematopoietiche &lt; 8 settimane prima della prima dose in studio 18.Grado 2 o maggiore di tossicità irrisolta per la prima terapia antineoplastica 19.Ricevere un forte inibitore di CYP3A4 &lt;2 settimane prima della prima dose in studio.
    E.5 End points
    E.5.1Primary end point(s)
    Phase 1 Primary Endpoints: • Adverse events (AEs), serious adverse events (SAEs), assessments of clinical laboratory values, and vital sign measurements • Plasma concentrations of brentuximab vedotin, total therapeutic antibody, and MMAE Phase 2 Primary Endpoints: The primary endpoints in phase 2 include: • Overall response rate (CR, PR) as determined by an IRF using PET, CT, and clinical assessment according to IWG revised response criteria
    • Gli eventi avversi (EA), eventi avversi gravi (SAE), le valutazioni dei valori clinici di laboratorio, e misurazioni delle funzioni vitali • Le concentrazioni plasmatiche di vedotin brentuximab, totale degli anticorpi terapeutici e MMAE Fase II endpoint primari: Gli endpoint primari nella fase II sono: • tasso di risposta globale (CR, PR), come determinato da un IRF utilizzando PET, CT, e la valutazione clinica secondo criteri di risposta IWG rivisti
    E.5.1.1Timepoint(s) of evaluation of this end point
    Does not have a specific timepoint.
    Fase I endpoint primario: • Gli eventi avversi (EA), eventi avversi gravi (SAE), le valutazioni dei valori clinici di laboratorio, e misurazioni delle funzioni vitali • Le concentrazioni plasmatiche di vedotin brentuximab, totale degli anticorpi terapeutici e MMAE Fase II endpoint primari: Gli endpoint primari nella fase II sono: • tasso di risposta globale (CR, PR), come determinato da un IRF utilizzando PET, CT, e la valutazione clinica secondo criteri di risposta IWG rivisti
    E.5.2Secondary end point(s)
    Phase 1 Secondary Endpoints: • Anti-therapeutic antibody (ATA) titer and neutralizing ATA titer • Overall response rate (CR, PR) as determined by an independent review facility (IRF) using positron emission tomography (PET), computed tomography (CT), and clinical assessment, according to International Working Group (IWG) revised response criteria • Time to progression • Time to response • Duration of response • Event-free survival • Progression-free survival • Overall survival Phase 2 Secondary Endpoints: • Time to progression • Time to response • Duration of response • Event-free survival • Progression-free survival • Overall survival • Adverse events, serious adverse events, assessments of clinical laboratory values, and vital sign measurements • Plasma concentrations of brentuximab vedotin, total therapeutic antibody, and MMAE • Anti-therapeutic antibody (ATA) titer and neutralizing ATA titer
    • titolo anti-terapeutico degli anticorpi (ATA) e neutralizzare titolo ATA • tasso di risposta globale (CR, PR), come determinato da un indipendente revisione impianto (IRF) utilizzando la tomografia ad emissione di positroni (PET), tomografia computerizzata (TC) e la valutazione clinica, secondo ilGruppo di lavoro internazionale (IWG) rivisti i criteri di risposta • Il tempo alla progressione • Tempo di risposta • Durata della risposta • sopravvivenza libera da eventi • sopravvivenza libera da progressione • La sopravvivenza globale Fase 2 endpoint secondario: • Il tempo alla progressione • Tempo di risposta • Durata della risposta • sopravvivenza libera da eventi • sopravvivenza libera da progressione • La sopravvivenza globale • Gli eventi avversi, eventi avversi gravi, le valutazioni di clinici valori di laboratorio, e misura delle funzioni vitali • Le concentrazioni plasmatiche di vedotin brentuximab, terapeutico totale anticorpi, e MMAE • Anti-terapeutico degli anticorpi (ATA), titolo e neutralizzare ATA titolo
    E.5.2.1Timepoint(s) of evaluation of this end point
    Does not have a specific timepoint.
    Non c'è uno specifico timepoint.
    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 Yes
    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
    Immunogenicity and biomarker analysis
    Immunogenicità e l'analisi dei biomarcatori
    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
    pediatric dose finding
    nuova indicazione
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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 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 No
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    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
    Last visit of the last subject
    Ultima visita dell'ultimo soggetto
    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 months63
    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 months63
    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: 42
    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: 14
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 28
    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
    Ensure each patient's parents/legal guardian provides signed and dated informed consent before conducting any study specific procedure
    Assicurarsi che i genitori/rappresentanti legali del paziente abbiano dato il loro consenso datato e firmato prima di condurre qualsiasi procedura studio specifica
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 27
    F.4.2.2In the whole clinical trial 42
    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)
    Not different from the expected normal treatment conditions
    Non differenti dal normale trattamento di tale condizione
    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 Decision2012-01-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-13
    P. End of Trial
    P.End of Trial StatusOngoing
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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