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    Summary
    EudraCT Number:2012-003101-10
    Sponsor's Protocol Code Number:CD-ON-CAT-80151036
    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:2013-05-08
    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 number2012-003101-10
    A.3Full title of the trial
    A Phase 2, Multicenter, Single-arm Study of Moxetumomab Pasudotox in Pediatric Subjects with Relapsed or Refractory Pediatric Acute Lymphoblastic Leukemia (pALL) or Lymphoblastic Lymphoma of B-cell Origin
    Studio di Fase 2, multicentrico, a braccio singolo di Moxetumomab Pasudotox in soggetti pediatrici affetti da leucemia linfoblastica acuta pediatrica (Pediatric Acute Lymphoblastic Leukemia, pALL) recidivante o refrattaria o da linfoma linfoblastico originato da cellule B
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2, Multicenter Study in Pediatric Subjects with Relapsed or Refractory Pediatric Acute Lymphoblastic Leukemia (pALL) or Lymphoblastic Lymphoma
    Studio di Fase 2, multicentrico, in soggetti pediatrici affetti da leucemia linfoblastica acuta pediatrica (Pediatric Acute Lymphoblastic Leukemia, pALL) recidivante o refrattaria o da linfoma linfoblastico
    A.4.1Sponsor's protocol code numberCD-ON-CAT-80151036
    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 SponsorMedImmune, LLC
    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 supportMedImmune, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedImmune, LLC
    B.5.2Functional name of contact pointClinical Trial Enquiries
    B.5.3 Address:
    B.5.3.1Street AddressOne MedImmune Way
    B.5.3.2Town/ cityGaithersburg, Maryland
    B.5.3.3Post code20878
    B.5.3.4CountryUnited States
    B.5.6E-mailclinicaltrialenquiries@medimmune.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 nameMoxetumomab Pasudotox
    D.3.2Product code CAT-8015
    D.3.4Pharmaceutical form Solution for infusion
    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 INNMoxetumomab Pasudotox
    D.3.9.1CAS number 1020748-57-5
    D.3.9.2Current sponsor codeCAT-8015
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number0.85
    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 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 Pediatric Acute Lymphoblastic Leukemia (pALL) or Lymphoblastic Lymphoma of B-cell Origin
    Leucemia linfoblastica acuta pediatrica (Pediatric Acute Lymphoblastic Leukemia, pALL) recidivante o refrattaria o da linfoma linfoblastico originato da cellule B
    E.1.1.1Medical condition in easily understood language
    Pediatric Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
    Leucemia linfoblastica acuta pediatrica o linfoma linfoblastico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10000845
    E.1.2Term Acute lymphoblastic leukemia
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10003939
    E.1.2Term B-lymphoblastic lymphoma (Kiel Classification)
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assess the efficacy defined as Composite Complete Response (CRc)
    Valutare l’efficacia misurata tramite la risposta completa composita (composite complete response, CRc)
    E.2.2Secondary objectives of the trial
    • Assess safety and tolerability
    • Assess immunogenicity and pharmacokinetics
    • Progression-free survival (PFS), overall survival (OS), Duration of complete response (DOCR), Duration of overall response (DOR)
    • Minimal residual disease negative CRc rate
    • Number eligible for stem cell transplant
    • Overall response rate (ORR)
    • Hematologic activity
    • Valutare la sicurezza e la tollerabilità
    • Valutare l'immunogenicità e la farmacocinetica
    • La sopravvivenza senza progressione (Progression-free survival, PFS), la sopravvivenza complessiva (overall survival, OS),
    la durata della risposta completa (duration of complete response, DOCR), la durata della risposta complessiva (duration of overall response, DOR).
    • Tasso della malattia residua minima negativa come risposta completa composita (composite complete response, CRc)
    • Numero elegibili per il trapianto di cellule staminali
    • Il tasso di risposta complessivo (overall response rate, ORR)
    • L'attività ematologica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following criteria:
    1) Between the ages of ≥ 6 months and < 18 years of age
    2) Written informed consent and written informed assent (if applicable)
    3) Must have histologically proven B-cell ALL or B-cell lymphoblastic lymphoma
    4) Measurable or evaluable disease
    5) Disease status:
    • Subjects must have relapsed or refractory disease and received at least 1 standard chemotherapy and either 1 salvage regimen or allogeneic HSCT.
    • In event of relapse after prior allogeneic HSCT, subjects must be at least 3 months post-transplant, have no evidence of active graft-vs-host disease, and been off immunosuppression for at least 4 weeks
    • Must have resolution of the acute toxic effects to ≤ Grade 2 from prior chemotherapy before entry, in the opinion of the investigator
    6) For non-leukemic subjects, an absolute neutrophil count (ANC) > 1000/µL, and platelet count > 50,000/mm2 are required, unless cytopenias are judged by the investigator to be due to underlying disease (ie, potentially reversible with anti-neoplastic therapy).
    7) Adequate Performance status.
    8) Subjects with central nervous system (CNS) status 1 or 2 are eligible only in the absence of neurologic symptoms, such as cranial nerve palsy, suggestive of CNS leukemia.
    9) Sexually active subjects must agree to use an approved method of contraception or abstinence to meet eligibility criteria.
    I soggetti devono soddisfare tutti i seguenti criteri:
    1) Età compresa tra ≥ 6 mesi < 18 ann.
    2) Consenso informato scritto e assenso informato scritto (laddove previsto)
    3) Presenza di ALL a cellule B o linfoma linfoblastico a cellule B
    4) Malattia misurabile o valutabile.
    5) Stato di malattia:
    • i soggetti devono presentare malattia recidivante o refrattaria ed essere stati sottoposti ad almeno un trattamento chemioterapico standard e a un regime di salvataggio oppure a un trapianto allogenico di cellule staminali;
    • in caso di recidiva successiva a pregresso HSCT allogenico, il periodo post-trapianto dei soggetti deve essere di almeno 3 mesi, i soggetti non devono presentare evidenze di malattia acuta da rigetto (GVHD, Graft versus Host Disease) in fase attiva e la terapia immunosoppressiva deve essere sospesa da almeno 4 settimane;
    • gli effetti tossici acuti dovuti a pregressa chemioterapia prima dell’ingresso nello studio devono essere risolti a un grado ≤ 2, secondo l’opinione dello sperimentatore.
    6) Per i soggetti non leucemici si richiede una conta assoluta dei neutrofili (ANC) > 1000/µl e una conta piastrinica > 50.000/mm2, a meno che un’eventuale citopenia non sia, a giudizio dello sperimentatore, dovuta a una patologia di base (ossia, potenzialmente reversibile con una terapia antineoplastica)..
    7) Stato prestazionale adeguato
    8) I soggetti con CNS 1 o 2 sono idonei solo in assenza di sintomi neurologici, come paralisi dei nervi cranici, indicativa di leucemia con interessamento del CNS.
    9) I soggetti sessualmente attivi dovranno, per essere elegibili,acconsentire all’adozione di un metodo contraccettivo approvato oppure praticare l’astinenza.
    E.4Principal exclusion criteria
    Any of the following would exclude the subject from participation in the study:
    1) Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
    2) Concurrent enrollment in another clinical study, unless it is a non-interventional, observational study or the subject is in the follow-up period from a previous study, or prior sponsor approval is obtained
    3) Employees of the study site directly involved with the study at the site of enrollment, or immediate family members of such individuals
    4) Isolated testicular or CNS ALL
    5) Inadequate hepatic function
    6) Inadequate renal function
    7) Radiologically-detected CNS lymphoma
    8) Laboratory findings consistent with Grade ≥ 3 disseminated intravascular coagulation (DIC) or any Grade 2 DIC that does not correct
    9) Hyperleukocytosis (WBC ≥ 50,000/μL) or rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy
    10) Pregnant or breast-feeding females
    11) Prior treatment with CAT-3888 (BL22), moxetumomab pasudotox, or any pseudomonas-exotoxin-containing compound
    12) Prior treatment with any anticancer biologic therapy within 2 weeks prior to enrollment, including but not limited to therapeutic monoclonal antibodies or antibody-drug conjugates
    13) Systemic chemotherapy ≤ 2 weeks (6 weeks for nitrosoureas) and radiation therapy ≤ 3 weeks prior to starting study drug with exceptions per protocol
    14) Other investigational antineoplastic agents within 30 days prior to Cycle 1, Dose of study treatment
    15) Human immunodeficiency virus (HIV) positive serology
    16) Seropositivity for hepatitis B (HBsAg) or hepatitis C (HCV antibody)
    17) Clinically significant ophthalmologic findings during the screening
    18) Uncontrolled, symptomatic, intercurrent illness that would limit study compliance
    19) Presence of a second invasive malignancy
    20) Any physical, social, or psychiatric condition, or any other condition which in the opinion of the investigator would prevent effective study cooperation or participation
    21) Uncontrolled pulmonary infection, presence of pulmonary edema
    22) Inadequate oxygen saturation
    23) Serum albumin < 2 g/dL
    24) Radioimmunotherapy within 2 years prior to study enrollment
    25) Subject with prior history of thrombotic microangiopathy or HUS.
    La presenza di una delle seguenti condizioni comporta l’esclusione del soggetto dalla partecipazione allo studio:
    1) Qualsiasi stato che, secondo l’opinione dello sperimentatore, potrebbe interferire con la valutazione del prodotto sperimentale o con l’interpretazione dei risultati dello studio o dei risultati relativi alla sicurezza del soggetto.
    2) Iscrizione concomitante ad un altro studio clinico, a meno che non si tratti di uno studio osservazionale non interventistico, oppure che il soggetto non si trovi nel periodo di follow-up di uno studio precedente, o non si ottenga la previa approvazione da parte dello sponsor.
    3) I soggetti sono dipendenti del centro dello studio e direttamente coinvolti nella conduzione dello studio stesso presso il centro di iscrizione, oppure sono familiari diretti di un tale dipendente.
    4) ALL testicolare isolata o con interessamento del CNS
    5) Funzionalità epatica inadeguata.
    6) Funzionalità renale inadeguata.
    7) Linfoma del CNS rilevato all’esame radiologico.
    8) Dati di laboratorio in linea con coagulazione intravascolare disseminata (CID) di grado ≥ 3 o eventuale CID di grado 2 non suscettibile di correzione.
    9) Iperleucocitosi (definita come conta leucocitaria totale ≥ 50.000/μl) o malattia in rapida progressione che, nelle previsioni dello sperimentatore e dello sponsor, comprometterebbe la capacità di portare a termine la terapia prevista dallo studio.
    10) Soggetti in stato di gravidanza o allattamento.
    11) Pregresso trattamento con CAT-3888 (BL22), moxetumomab pasudotox o qualsiasi altro composto contenente esotossine di Pseudomonas.
    12) Pregresso trattamento con terapia antineoplastica biologica nelle 2 settimane precedenti all’iscrizione incluse, ma non soltanto, terapie con anticorpi monoclonali o coniugati farmaco-anticorpo.
    13) Chemioterapia sistemica ≤ 2 settimane (6 settimane in caso di nitrosouree) e radioterapia ≤ 3 settimane prima di avviare l’assunzione del farmaco in studio, fatta eccezione per i casi previsti dal protocollo.
    14) Altri agenti antineoplastici sperimentali somministrati nei 30 giorni precedenti alla somministrazione della Dose 1, Ciclo 1 del farmaco in studio.
    15) Sieropositività al virus dell’immunodeficienza umana (HIV).
    16) Sieropositività per epatite B (HBsAg) o epatite C (anticorpi anti-HCV).
    17) Dati oftalmologici clinicamente significativi emersi allo screening.
    18) Patologia concomitante sintomatica non controllata che limiti la compliance ai requisiti dello studio.
    19) Presenza di seconda malignità invasiva.
    20) Qualsiasi condizione fisica, sociale o psichiatrica o di altro genere che, secondo l’opinione dello sperimentatore, impedirebbe la partecipazione o la cooperazione effettiva durante lo studio.
    21) Infezione polmonare non controllata, presenza di edema polmonare.
    22) Saturazione di ossigeno inadeguata.
    23) Albumina sierica < 2 g/dl.
    24) Radioimmunoterapia nei 2 anni precedenti alla data di arruolamento in studio.
    25) Soggetto con anamnesi pregressa di microangiopatia trombotica o HUS.
    E.5 End points
    E.5.1Primary end point(s)
    Assess the efficacy defined as composite complete response (CRc)
    Valutare l’efficacia misurata dalla risposta completa composita (composite complete response, CRc)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Disease assessments will be completed prior to the first cycle and subsequent cycles
    Le valutazioni della malattia saranno completate prima del primo ciclo e cicli successivi
    E.5.2Secondary end point(s)
    • Assess safety and tolerability
    • Assess immunogenicity and pharmacokinetics
    • PFS, OS, DOCR, DOR
    • Minimal residual disease negative CRc rate
    • Number eligible for stem cell transplant
    • ORR
    • Hematologic activity
    • Valutare la sicurezza e la tollerabilità
    • Valutare l'immunogenicità e la farmacocinetica
    • sopravvivenza senza progressione (Progression-free survival, PFS), sopravvivenza complessiva (overall survival, OS),
    durata della risposta completa (duration of complete response, DOCR), durata della risposta complessiva (duration of overall response, DOR).
    • Tasso della malattia residua minima negativa come risposta completa composita (composite complete response, CRc)
    • Numero elegibili per il trapianto di cellule staminali
    • Risposta complessiva (overall response rate, ORR)
    • Attività ematologica
    E.5.2.1Timepoint(s) of evaluation of this end point
    Duration of study
    Durata dello studio
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others 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) Yes
    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.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA29
    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
    Australia
    Canada
    France
    Germany
    Italy
    Netherlands
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    12 months after last subject begins treatment or earlier if interim analysis performed after enrollment of the first 33 evaluable subjects shows CRc ≤ 21%
    12 mesi dopo che l'ultimo soggetto inizia il trattamento o prima se l'esecuzione delle analisi ad interim dopo l'arruolamento dei primi 33 soggetti valutabili mostra una risposta completa composita (composite complete response, CRc) ≤ 21%
    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 days24
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days9
    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: 76
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 6
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 35
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 35
    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
    Pediatric subjects
    Soggetti pediatrici
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 33
    F.4.2.2In the whole clinical trial 76
    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)
    Standard of Care
    Standard di Cura
    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 Innovative Therapies for Children with Cancer (ITCC)
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-07-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-11-03
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