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    Summary
    EudraCT Number:2013-005542-11
    Sponsor's Protocol Code Number:20130109
    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:2014-06-11
    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 number2013-005542-11
    A.3Full title of the trial
    A Randomized, Double-Blind Study Evaluating the Efficacy, Safety and Immunogenicity of ABP 798 Compared with Rituximab in Subjects with CD20 Positive B-Cell Non-Hodgkin Lymphoma (NHL)
    Studio Randomizzato in Doppio Cieco per Valutare l’Efficacia, la Sicurezza e l’Immunogenicità di ABP 798 Rispetto a Rituximab in Soggetti affetti da Linfoma Non-Hodgkin (NHL) a Cellule B CD20 Positivo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The trial is designed to determine the efficacy and safety of ABP 798 compared with rituximab in subjects with CD 20 positive B-cell non Hodgkin lymphoma
    La sperimentazione è stata effettuata per determinare l’efficacia e la sicurezza di ABP 798 rispetto a rituximab in soggetti affetti da Linfoma Non-Hodgkin (NHL) a Cellule B CD20 Positivo
    A.3.2Name or abbreviated title of the trial where available
    Not Applicable
    Non Applicabile
    A.4.1Sponsor's protocol code number20130109
    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 SponsorAmgen 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 supportAmgen Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmgen (EUROPE) GmbH
    B.5.2Functional name of contact pointIHQ Medical Info-Clinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressDammstrasse 23, PO Box 1557
    B.5.3.2Town/ cityZug
    B.5.3.3Post codeCH-6300
    B.5.3.4CountrySwitzerland
    B.5.6E-mailMedinfointernational@amgen.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 nameABP 798
    D.3.2Product code ABP 798
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Intracartilaginous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNrituximab
    D.3.9.1CAS number 1446410-99-6
    D.3.9.2Current sponsor codeABP 798
    D.3.9.3Other descriptive nameABP 798 - Biosimilar to rituximab
    D.3.9.4EV Substance CodeSUB130918
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Rituxan
    D.2.1.1.2Name of the Marketing Authorisation holderGenentech, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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.3.4Pharmaceutical form Concentrate for 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 INNRituximab
    D.3.9.1CAS number 174722-31-7
    D.3.9.4EV Substance CodeSUB12570MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    CD20 positive B-cell non-Hodgkin lymphoma
    Linfoma Non-Hodgkin a Cellule B CD20 Positivo
    E.1.1.1Medical condition in easily understood language
    CD20 positive B-cell non-Hodgkin lymphoma
    Linfoma Non-Hodgkin a Cellule B CD20 Positivo
    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 17.0
    E.1.2Level HLGT
    E.1.2Classification code 10025320
    E.1.2Term Lymphomas non-Hodgkin's B-cell
    E.1.2System Organ Class 10005329 - Blood and lymphatic system 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 evaluate the efficacy of ABP 798 compared with rituximab
    Valutare l’efficacia di ABP 798 rispetto a rituximab
    E.2.2Secondary objectives of the trial
    To assess the pharmacokinetics (PK), pharmacodynamics, safety, tolerability, and immunogenicity of ABP 798 compared with rituximab
    Valutazione dei profili di farmacocinetica (PK), farmacodinamica, sicurezza, tollerabilità e immunogenicità di ABP 798 rispetto a rituximab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Males and females ≥ 18 and < 80 years of age

    Histological confirmed, Grade 1, 2 follicular B-cell NHL expressing CD20 within 3 months before randomization

    Stage 2, 3, or 4 (per Cotswold’s Modification of Ann Arbor Staging System) with measurable disease (per International Working Group)
    • subjects must have a baseline scan (computed tomography [CT]) of the neck (if palpable lymph node > 1.0 cm), chest, abdomen, and pelvis to assess disease burden within 28 days before randomization
    • subjects must have had a baseline bone marrow biopsy within 3 months before randomization

    Low tumor burden based on the Groupe d'Etudes des Lymphomes Folliculaires (GELF) criteria

    Blood counts:
    • absolute neutrophil count (ANC) ≥ 1.5 x 109 g/dL (1,500/μL)
    • lymphocytes < 1.5 x the upper limit of normal (ULN)
    • platelets ≥ 100 x 109 g/dL (100,000/μL)
    • hemoglobin ≥ 10.0 g/dL

    Adequate hepatic function as defined by:
    • aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2 × ULN

    Adequate renal function as defined by creatinine < 1.5 x ULN or estimated creatinine clearance ≥ 50 mL/min calculated by the Cockcroft-Gault method
    Pazienti di ambo i sessi, di età ≥ 18 e < 80 anni
    Diagnosi istologica di linfoma NHL follicolare a cellule B di Grado 1 o 2, CD20-positivo nei 3 mesi precedenti la randomizzazione
    Malattia di stadio 2, 3 o 4 (in base al sistema Cotswold’s Modification of Ann Arbor Staging System) con lesione misurabile (in base ai criteri International Working Group)
    •è richiesta la disponibilità di una scansione basale (tomografia computerizzata [TAC]) del collo (in presenza di linfonodo rilevato alla palpazione di dimensioni > 1,0 cm), torace, addome e bacino per una valutazione del carico tumorale nei 28 giorni precedenti la randomizzazione
    •è richiesta la disponibilità di una biopsia midollare basale nei 3 mesi precedenti la randomizzazione
    Carico tumorale basso in base ai criteri GELF (Groupe d'Etudes des Lymphomes Folliculaires)
    •linfonodo o lesione extranodale maggiore di dimensioni < 7 cm
    •interessamento di non più di 3 strutture linfonodali che misurino > 3 cm di diametro
    •assenza di splenomegalia (ovvero, dimensioni della milza < 16 cm secondo misurazione TAC; Brice et al., 1997)
    •assenza di versamenti di siero confermata da TAC
    •livelli normali di lattato deidrogenasi (LDH)
    Punteggio ECOG (Eastern Cooperative Oncology Group) pari a 0 o 1
    Parametri di laboratorio:
    •conta assoluta dei neutrofili (ANC) ≥ 1,5 x 109 g/dL (1.500/μL)
    •linfociti < 1,5 x volte il limite superiore della norma (ULN)
    •piastrine ≥ 100 x 109 g/dL (100.000/μL)
    •emoglobina ≥ 10,0 g/dL
    Funzione epatica adeguata determinata in base ai seguenti parametri:
    •bilirubina totale < 1,5 × ULN
    •aspartato aminotransferasi (AST) e alanina aminotransferasi (ALT) < 2 × ULN
    •i soggetti con elevazione dei livelli di bilirubina indiretta (sindrome di Gilbert) saranno considerati idonei se i rimanenti enzimi e test di funzionalità epatica (AST, ALT ed alcalina fosfatasi) rientrano nel range di normalità e in assenza di evidenza di emolisi.
    Funzione renale adeguata determinata in base a livelli di creatinina < 1,5 x ULN oppure clearance della creatinina stimata ≥ 50 mL/min calcolata mediante formula Cockcroft-Gault
    Soggetti che abbiano firmato il modulo di consenso informato approvato dal Comitato Etico Indipendente prima che sia stata eseguita qualsiasi procedura specifica per la sperimentazione
    E.4Principal exclusion criteria
    Diffuse large cell component and/or Grade 3 follicular NHL

    History or known presence of central nervous system metastases

    Malignancy other than NHL within 5 years (except treated in-situ cervical cancer, or squamous or basal cell carcinoma of the skin)

    Any of the following before randomization:
    • clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure [New York Heart Association ≥ Class III], serious uncontrolled cardiac arrhythmia);
    • peripheral vascular disease, cerebrovascular accident, or transient ischemic attack in the previous 6 months

    Medically uncontrolled hypertension or systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg

    Known active or history of active tuberculosis (TB)

    Positive for hepatitis B surface antigen, hepatitis B core antibody, or hepatitis C virus antibody at screening

    Known to be human immunodeficiency virus positive

    Recent infection requiring a course of systemic anti-infective agents that was completed ≤ 7 days before randomization (with the exception of uncomplicated urinary tract infection)

    Subject is currently enrolled in or has not yet completed at least 30 days or 5 half-lives (whichever is longer) since ending other investigational device or drug study(s), including vaccines, or subject is receiving other investigational agent(s)

    Previous use of either commercially available or investigational chemotherapy, biological, or immunological therapy for NHL (including rituximab or biosimilar rituximab, or other anti-CD20 treatments)

    Live vaccines within 28 days prior to the first dose of IP

    History of neurologic symptoms suggestive of central nervous system demyelinating disease

    Woman of childbearing potential who is pregnant or is breastfeeding

    Woman of childbearing potential who does not consent to use highly effective methods of birth control (eg, true abstinence, sterilization, birth control pills, Depo Provera injections, or contraceptive implants) during treatment and for an additional 12 months after the last administration of the protocol specified-treatment

    Man with a partner of childbearing potential who does not consent to use highly effective methods of birth control (eg, true abstinence, vasectomy, or a condom in combination with hormonal birth control or barrier methods used by the woman) during treatment and for an additional 12 months after the last administration of the protocol specified treatment

    Subject has known sensitivity to any of the products to be administered during the study, including mammalian cell derived drug products
    NHL con componente diffusa a grandi cellule e/o follicolare di Grado 3
    Storia o presenza nota di metastasi a carico del sistema nervoso centrale
    Radioterapia palliativa nei 3 mesi precedenti la randomizzazione
    Neoplasia maligna diversa da NHL nei 5 anni precedenti (con l’eccezione delle seguenti neoplasia trattate: carcinoma cervicale in situ, carcinoma cutaneo squamocellulare o basocellulare)
    interventi chirurgici maggiori programmati per il periodo di trattamento
    Presenza di una delle seguenti condizioni prima della randomizzazione:
    •patologia cardiovascolare clinicamente significativa (compreso infarto del miocardio, angina instabile, scompenso cardiaco congestizio sintomatico [Classe NYHA ≥ III], aritmia cardiaca seria e non controllata);
    •vasculopatia periferica, evento cerebrovascolare o attacco ischemico transitorio nei 6 mesi precedenti
    Ipertensione non controllata farmacologicamente oppure pressione arteriosa sistolica > 160 mmHg o pressione diastolica > 100 mmHg
    Storia di tubercolosi oppure presenza nota di tubercolosi (TBC) in forma attiva
    Positività all’antigene di superficie per l’epatite B, all’anticorpo anti-core dell’epatite B, o per l’anticorpo al virus dell’epatite C allo screening
    Nota positività al virus dell’immunodeficienza umana
    Recente infezione che abbia richiesto un ciclo di trattamento sistemico con agenti antiinfettivi terminato ≤ 7 giorni prima della randomizzazione (con l’eccezione delle infezioni non complicate delle vie urinarie)
    Durante la partecipazione a questa sperimentazione non è permesso sottoporsi a procedure previste da altre sperimentazioni
    Soggetto attualmente arruolato in una sperimentazione o in precedenza arruolato in una sperimentazione ma per cui non siano ancora trascorsi almeno 30 giorni o un periodo equivalente a 5 emivite (quale dei due periodi sia il più lungo) dalla conclusione del trattamento con l’altro dispositivo o farmaco/farmaci sperimentali (compresi vaccini), o soggetto che attualmente stia ricevendo uno o più agenti sperimentali
    Uso pregresso di agenti chemioterapici commercializzati o sperimentali, agenti biologici o terapia immunologica per NHL (compreso rituximab o biosimilare di rituximab, oppure altri trattamenti anti-CD20)
    Uso di corticosteroidi sistemici nei 3 mesi precedenti la randomizzazione (sono permessi corticosteroidi per inalazione)
    Immunizzazione con vaccini vivi nei 28 giorni precedenti la somministrazione della prima dose dell’IMP
    Storia di sintomi neurologici indicativi della presenza di patologie demielinizzanti a carico del sistema nervoso centrale
    Pazienti di sesso femminile in età fertile in stato di gravidanza o che stanno allattando al seno
    Pazienti di sesso femminile in età fertile che non acconsentono a fare uso di metodi efficaci di contraccezione (ovvero astinenza reale, sterilizzazione chirurgica, uso di contraccettivi orali, iniezione di Depo Provera oppure contraccettivi impiantabili) nel corso del trattamento e per ulteriori 12 mesi dopo l’ultima somministrazione del trattamento previsto dal protocollo
    Pazienti di sesso maschile con partner di sesso femminile in età fertile, che non acconsentono a fare uso di metodi contraccettivi efficaci (ovvero astinenza reale, vasectomia oppure preservativo utilizzato in associazione a contraccettivo ormonale oppure metodo di barriera utilizzato dalla partner) nel corso del trattamento e per ulteriori 12 mesi dopo l’ultima somministrazione del trattamento previsto dal protocollo
    Soggetto con nota sensibilità a uno dei prodotti che saranno somministrati nel corso della sperimentazione, compresi agenti farmacologici derivati da cellule di mammiferi
    Soggetto randomizzato in precedenza nell’ambito di questa sperimentazione
    Soggetto per cui non è possibile escludere difficoltà a portare a termine tutte le visite e/o procedure previste dal protocollo
    Storia o evidenza di altri disturbi, condizioni o patologie clinicamente significativi (ad eccezione di quelli elencati sopra) che a giudizio dello Sperimentatore o, se consultato, del medico di Amgen, costituirebbe un rischio per la sicurezza del soggetto o interferirebbe con le valutazioni, le procedure o il completamento della sperimentazione
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint: (risk difference [RD] of objective response rate [ORR] by week 28
    Differenza di rischio (risk difference - RD) del tasso di risposta globale (overall response rate - ORR) entro la settimana 28
    E.5.1.1Timepoint(s) of evaluation of this end point
    Clinical disease assessment & PK sampling: v1 (D1), v2 (w2), v3 (w3), v4 (w4), v5 (w12), v6 (w20), end of study (w28)

    CT Scan: screening, v5 (w12), end of study (w28)

    Bone marrow biopsy: screening, end of study (w28)

    Serum chemistry & Hematology: screening, v1 (D1), v2 (w2), v3 (w3), v4 (w4), v5 (w12), v6 (w20), end of study (w28)

    Pharmacodynamic (CD19) and IgG and IgM: v1 (D1), v2 (w2), v3 (w3), v4 (w4), end of study (w28)
    Esame obiettivo e Campioni per esami di farmacocinetica v1 (g1), v2 (s2), v3 (s3),
    v4 (s4), v5 (s12), v6 (s20), fine studio (s28)

    TAC : screening, V5 (s12) , fine studio (s28)

    Biopsia del midollo osseo: screening, fine studio (s28)

    Test emetologici e chimici : screening, v1 (g1), v2 (s2), v3 (s3),
    v4 (s4), v5 (s12), v6 (s20), fine studio (s28)

    Farmacodinamica (CD19) e IgG e IgM: v1 (g1), v2 (s2), v3 (s3),
    v4 (s4), fine studio (s28)
    E.5.2Secondary end point(s)
    Secondary Efficacy Criteria: Risk difference (RD) of overall response rate (ORR) at week 12

    Pharmacokinetic and Pharmacodynamic Criteria:
    • Serum concentrations at predose and immediately after the end of infusion at weeks 4, 12, and 20.
    • Percent of subjects with complete depletion of CD19 cell count, from baseline to study day 8, and total IgG and IgM antibody levels

    Safety Criteria:
    • Treatment-emergent adverse events (AEs) and serious AEs (SAEs)
    • Clinically significant changes in laboratory values and vital signs
    • Incidence of anti-drug antibodies
    • On study progression-free survival (PFS)
    • On study overall survival (OS)
    Differenza di rischio (RD) del tasso di risposta globale (ORR) alla settimana 12
    Criteri di Farmacocinetica e Farmacodinamica
    • Concentrazioni sieriche misurate prima e immediatamente dopo l’infusione, alle settimane 4, 12 e 20.
    • Percentuale di soggetti con deplezione totale delle cellule CD19 nel periodo intercorrente fra baseline e giorno 8 della sperimentazione
    Criteri di Sicurezza:
    • Eventi avversi emergenti dal trattamento (AE) ed eventi avversi seri (SAE)
    • Alterazioni clinicamente significative di parametri di laboratorio e segni vitali
    • Incidenza di anticorpi anti-farmaco
    • Sopravvivenza libera da progressione (PFS) in corso di sperimentazione
    • Sopravvivenza globale (OS) in corso di sperimentazione
    E.5.2.1Timepoint(s) of evaluation of this end point
    Clinical disease assessment & PK sampling: v1 (D1), v2 (w2), v3 (w3), v4 (w4), v5 (w12), v6 (w20), end of study (w28)

    CT Scan: screening, v5 (w12), end of study (w28)

    Bone marrow biopsy: screening, end of study (w28)

    Serum chemistry & Hematology: screening, v1 (D1), v2 (w2), v3 (w3), v4 (w4), v5 (w12), v6 (w20), end of study (w28)

    Pharmacodynamic (CD19) and IgG and IgM: v1 (D1), v2 (w2), v3 (w3), v4 (w4), end of study (w28)

    Antidrug antibodies: v1 (D1), v5 (w12), v6 (w20), end of study (w28)
    Esame obiettivo e Campioni per esami di farmacocinetica v1 (g1), v2 (s2), v3 (s3),
    v4 (s4), v5 (s12), v6 (s20), fine studio (s28)

    TAC : screening, V5 (s12) , fine studio (s28)

    Biopsia del midollo osseo: screening, fine studio (s28)

    Test emetologici e chimici : screening, v1 (g1), v2 (s2), v3 (s3),
    v4 (s4), v5 (s12), v6 (s20), fine studio (s28)

    Farmacodinamica (CD19) e IgG e IgM: v1 (g1), v2 (s2), v3 (s3),
    v4 (s4), fine studio (s28)

    Anticorpi antifarmaco v1 (g1), v5 (s12), v6 (s20), fine studio (s28)
    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 Yes
    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
    Immunogenicity
    immunogenicità
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) Yes
    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 concerned18
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA63
    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
    Belarus
    Bulgaria
    Canada
    Czech Republic
    France
    Germany
    Hungary
    Italy
    Japan
    Mexico
    New Zealand
    Poland
    Romania
    Russian Federation
    Serbia
    Spain
    Taiwan
    Ukraine
    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
    LVLS
    LVLS
    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 months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    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: 125
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 125
    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 122
    F.4.2.2In the whole clinical trial 250
    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
    nessuno
    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 Decision2014-08-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-29
    P. End of Trial
    P.End of Trial StatusCompleted
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