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    Summary
    EudraCT Number:2014-002117-28
    Sponsor's Protocol Code Number:ACE-LY-004
    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:2021-02-10
    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 number2014-002117-28
    A.3Full title of the trial
    An Open-label, Phase 2 Study of ACP-196 in Subjects
    with Mantle Cell Lymphoma
    Studio di Fase 2 in Aperto su ACP-196 in Soggetti affetti da Linfoma Mantellare
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Trial to See the Effects of ACP-196 (the test drug) in Patients who have Mantle Cell Lymphoma
    Una Sperimentazione per Osservare gli Effetti ACP-196 (il farmaco test) in Pazienti con Linfoma Mantellare
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberACE-LY-004
    A.5.4Other Identifiers
    Name:IND NumberNumber:118717
    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 SponsorACERTA PHARMA BV
    B.1.3.4CountryNetherlands
    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 supportAcerta Pharma BV
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcerta Pharma BV
    B.5.2Functional name of contact pointACE-LY-004 Clincial Team
    B.5.3 Address:
    B.5.3.1Street AddressPivot Park, Kloosterstraat 9
    B.5.3.2Town/ cityOss
    B.5.3.3Post code5319AB
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+16505912800
    B.5.5Fax number0000000000000000
    B.5.6E-mailace-ly-004@acerta-pharma.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 nameacalabrutinib
    D.3.2Product code ACP-196
    D.3.4Pharmaceutical form Capsule, hard
    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 INNacalabrutinib
    D.3.9.1CAS number 00-00-0
    D.3.9.2Current sponsor codeACP-196
    D.3.9.3Other descriptive nameACP-196
    D.3.9.4EV Substance CodeSUB166233
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Mantle Cell Lymphoma
    Linfoma Mantellare
    E.1.1.1Medical condition in easily understood language
    lymphoma (nodes of the neck, chest, armpit or groin) cancer
    cancro linfoma (linfonodi di collo, petto, ascelle o inguine)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10026798
    E.1.2Term Mantle cell lymphomas
    E.1.2System Organ Class 100000004851
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10026798
    E.1.2Term Mantle cell lymphomas
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the activity of ACP-196 in subjects with relapsed or refractory MCL as measured primarily by response rate. In addition, activity of ACP-169 will be assessed by duration of response, progression-free survival, and overall survival.
    Determinare l¿attivit¿ di ACP-196 in soggetti con MCL recidivante e refrattaria, come primariamente misurata mediante il tasso di di risposta. Inoltre, l¿attivit¿ di ACP-196 sar¿ valutata utilizzando la durata della risposta, la sopravvivenza senza progressione e la sopravvivenza complessiva.
    E.2.2Secondary objectives of the trial
    ¿ To characterize the safety profile of ACP-196
    ¿ To characterize the pharmacokinetic (PK) profile of ACP-196
    ¿ To evaluate the PD effects of ACP-196
    ¿ Caratterizzare il profilo di sicurezza di ACP-196
    ¿ Caratterizzare il profilo di PK di ACP-196
    ¿ Valutare gli effetti di PD di ACP-196
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Men and women aged 18 years.
    • Pathologically confirmed MCL, with documentation of monoclonal B cells
    die have a chromosomal translocation t (11; 14) (q13; q32) and / or one
    overexpression of cyclin Dl.
    • Relapsing disease after, or refractory to, 1 previous therapy for [V1CL and now
    requesting further treatment.
    • Failure to document at least one RP with the regime of
    recent pki treatment or progression of the disease documented after the regimen
    of more recent treatment.
    • Presence of lymphadenopathy or extranodal lymphoid malignancy
    radiologically measurable (defined as the presence of 1 lesion that measures
    2.0 cm in the longest dimension and 1.0 cm in the perpendicular dimension
    long standing evaluated by computerized tomography [TC]).
    • At least 1, but no more than 5, previous treatment regimens for MCL. (Note: I
    subjects who received 2 dcli of previous treatment with bortezomib or
    any other commercially available proteasome inhibitor, either as an agent
    in monotherapy or as part of a combination therapeutic regimen, they will come
    considered exposed to proteasome inhibitor).
    Status of validity according to the Eastern Group of Cooperative Oncology (Eastern
    Cooperative Oncology Group, ECOG) <2.
    • Sexually active women who are able to conceive children must accept
    use highly effective forms of contraception during the study and for 2 days
    after the last dose of the study drug
    • This criterion is removed as per protocol version 8Volontà and possibility of
    participate in all assessments and procedures required by this protocol
    study, including the ability to swallow the capsules without difficulty.
    • Ability to understand the purpose and risks of the study and to provide a consensus
    informed signed and dated and authorization to use health information
    protected (in compliance with national and local regulations concerning the privacy of the
    subject).
    • Uomini e donne di eta 18 anni.
    • MCL confermata patologicamente, con Ia documentazione di cellule monoclonali B
    die hanno una traslocazione cromosomica t (11;14)(q13;q32) e/o una
    sovraespressione della ciclina Dl.
    • Malattia recidivante dopo, o refrattaria a, 1 precedente terapia per ii [V1CL e ora
    richiedente un ulteriore trattamento.
    • Mancato raggiungimento documentato di almeno una RP con ii regime di
    trattamento pki recente o progressione della malattia documentata dopo ii regime
    di trattamento pià recente.
    • Presenza di linfoadenopatia o neoplasia maligna linfoide extranodale
    radiologicamente misurabile (definita come Ia presenza di 1 lesione che misuri
    2,0 cm nella dimensione pi’i lunga e 1,0 cm nella dimensione perpendicolare
    pii lunga valutata mediante tomografia computerizzata [TC]).
    • Almeno 1, ma non pià di 5, precedenti regimi di trattamento per ii MCL. (Nota: I
    soggetti che hanno ricevuto 2 dcli di trattamento precedenti con bortezomib o
    qualsiasi altro inibitore della proteasoma disponibile in commercio, sia come agente
    in monoterapia o come parte di un regime terapeutico di combinazione, verranno
    considerati esposti a inibitore della proteasoma).
    Stato di validità secondo il Gruppo Orientale di Oncologia Cooperativa (Eastern
    Cooperative Oncology Group, ECOG) < 2.
    • Le donne sessualmente attive e in grado di concepire figli devono accettare di
    utilizzare forme di contraccezione altamente efficaci durante lo studio e per 2 giorni
    dopo l’ultima dose del farmaco dello studio
    • Questo criterio viene rimosso come da protocollo versione 8Volontà e possibilità di
    partecipare a tutte le valutazioni e le procedure richieste da questo protocollo di
    studio, inclusa Ia capacità di inghiottire Ie capsule senza difficoltà.
    • Capacità di comprendere lo scopo e i rischi dello studio e di fornire un consenso
    informato firmato e datato e l’autorizzazione all’utilizzo di informazioni sanitarie
    protette (in conformità alle normative nazionali e locali riguardanti Ia privacy del
    soggetto).
    E.4Principal exclusion criteria
    1. Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for = 2 years or which will not limit survival to < 2 years. Note: these cases must be discussed with the Medical Monitor.
    2. A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of ACP-196, or put the study outcomes at undue risk.
    3. Significant cardiovascular disease such as uncontrolled or
    symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or or corrected QT interval (QTc)> 480 msec.
    4. Malabsorption syndrome, disease significantly affecting
    gastrointestinal function, or resection of the stomach or small bowel, gastric bypass, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
    5. Any immunotherapy within 4 weeks of first dose of study drug.
    6. The time from the last dose of the most recent chemotherapy or experimental therapy to the first dose of study drug is < 5 times the half-life of the previously administered agent(s).
    7. Prior exposure to a BCR inhibitor (eg, Btk, phosphoinositide- 3 kinase (PI3K), or Syk inhibitors) or BCL-2 inhibitor (eg, ABT-199).
    8. Ongoing immunosuppressive therapy, including systemic or enteric corticosteroids for treatment of MCL or other conditions. Note: Subjects may use topical or inhaled corticosteroids or low-dose steroids (= 10 mg of prednisone or equivalent per day) as therapy for comorbid conditions.
    During study participation, subjects may also receive systemic or enteric corticosteroids as needed for treatment-emergent comorbid conditions.
    9. Grade = 2 toxicity (other than alopecia) continuing from prior
    anticancer therapy including radiation.
    10. Known history of human immunodeficiency virus (HIV) or active infection with hepatitis C virus (HCV) or hepatitis B virus (HBV) or any uncontrolled active systemic infection.
    11. Major surgery within 4 weeks before first dose of study drug.
    12. Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura.
    13. Known history of a bleeding diathesis (eg, hemophilia, von Willebrand disease)
    14. History of stroke or intracranial hemorrhage within 6 months before the first dose of study drug.
    15. Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonist (eg, phenprocoumon) within 7 days of first dose
    of study drug.
    16. Requires treatment with proton pump inhibitors (eg, omeprazole, esomeprazole, lansoprazole, exlansoprazole, rabeprazole,or pantoprazole).
    17. ANC < 0.75 x 109/L or platelet count < 50 x 109/L; for subjects with disease involvement in the bone marrow, ANC < 0.50 x 109/L or platelet
    count < 30 x 109/L.
    18. Creatinine > 2.5 x institutional upper limit of normal (ULN); total bilirubin > 2.5 x ULN ; and aspartate aminotransferase (AST) or alanine
    aminotransferase (ALT) > 3.0 x ULN.
    19. Breastfeeding or pregnant.
    20. Concurrent participation in another therapeutic clinical trial.
    21. Known central nervous system (CNS) lymphoma or leptomeningeal
    disease.
    22. Requires treatment with a strong CYP3A4 inhibitor/inducer.
    23. Presence of a gastrointestinal ulcer diagnosed by endoscopy within 3
    months prior to screening.
    1. Precedente neoplasia maligna, ad eccezione dei casi di carcinoma cutaneo basocellulare o squamocellulare, carcinoma in situ della cervice uterina o altro tumore adeguatamente trattato, per cui il soggetto sia libero da malattia da >= 2 anni o che non limiti la sopravvivenza a < 2 anni. Nota: questi casi devono essere discussi con il responsabile del Monitoraggio Medico di Acerta Pharma.
    2. Malattia, condizione medica o disfunzione di organo potenzialmente letale che, a giudizio dello sperimentatore, possano compromettere la sicurezza del soggetto, interferire con l’assorbimento o il metabolismo di ACP-196 o esporre gli esiti dello studio a un rischio eccessivo.
    3. Malattia cardiovascolare significativa, come aritmie non controllate o sintomatiche, insufficienza cardiaca congestizia o infarto del miocardio nei 6 mesi precedenti lo screening oppure qualsiasi cardiopatia di classe 3 o 4 secondo quanto definito in base alla Classificazione funzionale della New York Heart Association o o intervallo QT corretto (QTc)> 480 ms.
    4. Sindrome da malassorbimento, malattia che influisca significativamente sulla funzione gastrointestinale o resezione gastrica o dell’intestino tenue, bypass gastrico, malattia infiammatoria intestinale sintomatica, oppure ostruzione intestinale parziale o completa.
    5. Qualsiasi immunoterapia nelle 4 settimane precedenti alla prima dose del farmaco dello studio.
    6. Il tempo intercorrente tra l’ultima dose di chemioterapia o terapia sperimentale più recente e la prima dose del farmaco dello studio deve essere 5 volte inferiore all’emivita di uno o più degli agenti precedentemente somministrati.
    7. Precedente esposizione a un inibitore del BCR (ad esempio, inibitori della Btk o inibitori della fosfoinositide-3 chinasi [Phosphoinositide-3 Kinase, PI3K], o inibitori della proteina tirosin chinasi della milza (Spleen Tyrosine Kinase, SYK) o inibitore della proteina BCL-2 [B-Cell Lymphoma 2]) (ad esempio, ABT-199).
    8. Terapia immunosoppressiva in corso, inclusi corticosteroidi per via sistemica o enterale, per il trattamento del MCL o di altre condizioni. Nota: i soggetti possono utilizzare corticosteroidi per uso topico o inalatorio o basse dosi di steroidi (<= 10 mg di prednisone o equivalente al giorno) come terapia per le patologie concomitanti. Durante la partecipazione allo studio, inoltre, i soggetti potranno ricevere corticosteroidi per via sistemica o enterale al bisogno per comorbilità emergenti dal trattamento.
    9. Tossicità di grado >= 2 (eccetto alopecia) persistente dopo la terapia antitumorale precedente, inclusa la radioterapia.
    10. Anamnesi nota di infezione da virus dell’immunodeficienza umana (Human Immunodeficiency Virus, HIV) o di infezione attiva da virus dell’epatite C (Hepatitis C Virus, HCV) o dell’epatite B (Hepatitis B Virus, HBV) o di qualunque infezione sistemica attiva non controllata.
    11. Intervento chirurgico rilevante nelle 4 settimane precedenti la prima dose di ACP-196.
    12. Anemia emolitica autoimmune non controllata o porpora trombocitopenica idiopatica.
    13. Nota anamnesi di una diatesi emorragica (ad esempio, emofilia, malattia di von Willebrand)
    14. Anamnesi di ictus o emorragia intracranica nei 6 mesi precedenti la prima dose di ACP-196.
    15. Richiede o riceve terapia anticoagulante con warfarin o antagonista equivalente della vitamina K (ad esempio, fenprocumone) entro 7 giorni dalla prima dose del farmaco dello studio.
    16. Richiede il trattamento con inibitori della pompa protonica (ad esempio, omeprazolo, esomeprazolo, lansoprazolo, dexlansoprazolo, rabeprazolo, o pantoprazolo)
    17. Conta assoluta dei neutrofili (Absolute Neutrophil Count, ANC) < 0,75 x 109/l o conta piastrinica < 50 x 109/l; per i soggetti con coinvolgimento patologico del midollo osseo, ANC < 0,50 x 109/o conta piastrinica < 30 x 109/l.
    18. Creatinina 2,5 volte superiore al limite superiore di normalità (Upper Limit Of Normal, ULN) istituzionale, bilirubina totale 2,5 volte superiore all’ULN o aspartato aminotransferasi (AST) o alanina aminotransferasi (ALT) 3,0 volte superiore all’ULN.
    19. Gravidanza o allattamento.
    20. Partecipazione concomitante ad altra sperimentazione clinica terapeutica.
    21 Noto linfoma del sistema nervoso centrale (SNC) o malattia leptomeningeale.
    22 Necessità di trattamento con un potente inibitore/induttore del
    citocromo P450 3A4 (CYP3A4).
    23 Presenza di ulcera gastrointestinale diagnosticata tramite
    endoscopia nei 3 mesi precedenti lo screening.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is the overall response rate (ORR),
    defined as a subject achieving either a partial response (PR) or complete
    response (CR) according to the Lugano Classification for NHL as
    assessed by investigators.
    L’endpoint primario dello studio è il tasso di risposta complessiva
    (Overall Response Rate, ORR), definito come un soggetto che
    raggiunga una risposta parziale (RP) o una risposta completa (RC)
    in accordo ai Criteri di classificazione di Lugano per i LNH (Cheson
    2014), secondo il giudizio degli sperimentatori.
    E.5.1.1Timepoint(s) of evaluation of this end point
    @ 30 days after stopping study treatment
    30 gg dopo l'interruzione del trattamento in studio
    E.5.2Secondary end point(s)
    Efficacy:
    • Response time (DR)
    • Progressive Free Survival (Progression-Free Survival, PFS)
    • Overall Survival (Overall Survival, OS)
    Safety:
    • Frequency and severity of adverse events
    • Frequency of EAs requiring discontinuation of the study or study
    dose reductions
    • Effect of acalabrutininb on peripheral T / B / NK cell counts
    • Effect of acalabrutinib on serum immunoglobulin levels
    Pharmacokinetics:
    • Plasmatic pharmacokinetics of acalabrutinib
    Exploration endpoint:
    • Results reported by the patient (Patient Reported Outcomes, PRO):
    • Quality of life related to health (Health-Related Quality of Life); Safety:
    ¿ frequency, severity, and relatedness of adverse events
    ¿ frequency of adverse events requiring discontinuation of study drug or
    dose reductions
    ¿ effect of ACP-196 on peripheral T/B/NK cell counts
    ¿ effect of ACP-196 on serum immunoglobulin levels; Pharmacokinetics:
    ¿ plasma pharmacokinetics of ACP-196; Patient Reported Outcomes (PRO):
    ¿ health-related quality of life
    Efficacia:
    • Durata della risposta (DR)
    • Sopravvivenza libera da progressione (Progression-Free Survival, PFS)
    • Sopravvivenza complessiva (Overall Survival, OS)
    Sicurezza:
    • Frequenza e gravità degli eventi avversi
    • Frequenza degli EA che richiedono l’interruzione del farmaco deMo studio o
    riduzioni della dose
    • Effetto di acalabrutininb sulle conte delle cellule T/B/NK periferiche
    • Effetto di acalabrutinib sui livelli sierici di immunoglobuline
    Farmacocinetica:
    • Farmacocinetica plasmatica di acalabrutinib
    Endpoint esplorativo:
    • Esiti riferiti dal paziente (Patient Reported Outcomes, PRO):
    • Qualità della vita correlata alla salute (Health-Related Quality of Life); Sicurezza:
    ¿ Frequenza, gravit¿ e correlazione degli eventi avversi (EA)
    ¿ Frequenza degli EA che richiedono l¿interruzione del farmaco dello studio o riduzioni della dose
    ¿ Effetto di ACP-196 sulle conte delle cellule T/B/NK periferiche
    ¿ Effetto di ACP-196 sui livelli sierici di immunoglobuline; Farmacocinetica:
    ¿ Farmacocinetica plasmatica di ACP-196; Esiti riferiti dal paziente (Patient Reported Outcomes, PRO):
    ¿ Qualit¿ della vita correlata alla salute (Health-Related Quality of Life)
    E.5.2.1Timepoint(s) of evaluation of this end point
    @ 30 days after stopping study treatment; @ 30 days after stopping study treatment; @ 30 days after stopping study treatment; @ 30 days after stopping study treatment
    30 giorni dopo l'interruzione del trattamento in studio; 30 giorni dopo l'interruzione del trattamento in studio; 30 giorni dopo l'interruzione del trattamento in studio; 30 giorni dopo l'interruzione del trattamento in 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 Yes
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Australia
    Israel
    United States
    Belgium
    France
    Italy
    Spain
    Sweden
    United Kingdom
    Czechia
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 59
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 58
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 117
    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)
    None defined. The clinical trial continues while subjects continue to
    receive clinical benefit.
    Nessuno definito. Lo studio clinico continua fin tanto che i pazienti ne traggono beneficio clinico
    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 Decision2015-06-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-15
    P. End of Trial
    P.End of Trial StatusOngoing
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