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    Summary
    EudraCT Number:2018-000665-36
    Sponsor's Protocol Code Number:20180015
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-01-22
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2018-000665-36
    A.3Full title of the trial
    A Randomized, Open-label, Phase 3 Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination with Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma (A.R.R.O.W.2)
    Estudio de fase 3 aleatorizado y abierto en el que se compara el tratamiento con carfilzomib una vez por semana frente a dos veces por semana en combinación con lenalidomida y dexametasona en sujetos con mieloma múltiple en recaída o refractario (A.R.R.O.W.2)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study Comparing Once-weekly vs Twice-weekly Carfilzomib in Combination with Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
    Estudio en el que se compara el tratamiento con carfilzomib una vez por semana frente a dos veces por semana en combinación con lenalidomida y dexametasona en sujetos con mieloma múltiple en recaída o refractario
    A.3.2Name or abbreviated title of the trial where available
    A.R.R.O.W.2
    A.4.1Sponsor's protocol code number20180015
    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, P.O 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 Yes
    D.2.1.1.1Trade name Kyprolis
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/08/548
    D.3 Description of the IMP
    D.3.1Product nameCarfilzomib Lyophilisate for Solution for Injection
    D.3.2Product code PR-171
    D.3.4Pharmaceutical form Powder 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 INNcarfilzomib
    D.3.9.1CAS number 868540-17-4
    D.3.9.2Current sponsor codePR-171
    D.3.9.3Other descriptive nameCARFILZOMIB
    D.3.9.4EV Substance CodeSUB32911
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relapsed or Refractory Multiple Myeloma
    mieloma múltiple en recaída o refractario
    E.1.1.1Medical condition in easily understood language
    Bone marrow Cancer
    Cáncer de Médula Ósea
    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 LLT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    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
    compare efficacy of
    56 mg/m2 carfilzomib administered
    once-weekly in combination with
    lenalidomide and dexamethasone
    (KRd 56 mg/m2) to
    27 mg/m2 carfilzomib administered
    twice-weekly in combination with
    lenalidomide and dexamethasone
    (KRd 27 mg/m2) in subjects with
    RRMM with 1 to 3 prior lines of
    therapy
    Comparar la eficacia del tratamiento con 56 mg/m2 de carfilzomib administrado una vez por semana en combinación con lenalidomida y dexametasona (56 mg/m2 de KRd) con la del tratamiento con 27 mg/m2 de carfilzomib administrado dos veces por semana en combinación con lenalidomida y dexametasona (27 mg/m2 de KRd) en sujetos con mieloma múltiple en recaída o refractario (MMRR) con 1 a 3 líneas de tratamiento previas.
    E.2.2Secondary objectives of the trial
    *compare progression-free survival
    (PFS) between treatment arms
    *compare patient-reported
    convenience with carfilzomib-dosing
    schedule between treatment arms
    *Comparar la supervivencia libre de progresión (SLP) entre los grupos de tratamiento.
    *Comparar la comodidad notificada por los pacientes con la pauta de administración de carfilzomib entre los grupos de tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    *Subject has provided informed consent prior to initiation of any study-specific
    activities or procedures or subject’s legally acceptable representative has
    provided informed consent prior to any study-specific activities/procedures being
    initiated when the subject has any kind of condition that, in the opinion of the
    Investigator, may compromise the ability of the subject to give written informed
    consent.
    *Males or females ≥ 18 years of age.
    *Documented relapse or progressive multiple myeloma on or after any treatment
    (subjects refractory to the most recent line of therapy are eligible, unless last
    treatment contained PI or lenalidomide and dexamethasone).
    *Subjects must have at least PR to at least 1 line of prior therapy.
    *Subjects must have received at least 1 but not more than 3 prior lines of therapy
    for multiple myeloma (induction therapy followed by stem cell transplant and
    consolidation maintenance therapy will be considered as 1 line of therapy). See
    Section 12.8 for guidelines for documenting prior treatment.
    *Prior therapy with a PI or lenalidomide and dexamethasone is allowed, as long
    as the patient had at least a PR to most recent therapy with PI or lenalidomide
    and dexamethasone, was not removed due to toxicity, and will have at least a
    6-month PI or lenalidomide and dexamethasone treatment-free interval from last
    dose received until first study treatment. (Patients may receive maintenance
    therapy with lenalidomide during this 6-month PI or lenalidomide and
    dexamethasone treatment-free interval).
    *Previous treatment with a lenalidomide and dexamethasone containing regimen
    is allowed, as long as the subject did not progress during the first 3 months after
    initiating lenalidomide and dexamethasone containing therapy.
    Measurable disease with at least 1 of the following assessed within 21 days prior
    to randomization:
     IgG multiple myeloma: serum monoclonal protein (M-protein) level ≥ 1.0 g/dL
     IgA, IgD, IgE multiple myeloma: serum M-protein level ≥ 0.5 g/dL
     urine M-protein ≥ 200 mg per 24 hours
     in subjects without measurable serum or urine M-protein, serum-free light
    chain (SFLC) ≥ 100 mg/L (involved light chain) and an abnormal serum
    kappa lambda ratio
    *Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0  2
    (see Section 12.9).
    *El sujeto ha proporcionado su consentimiento informado antes de iniciar cualquier actividad o procedimiento específico del estudio o el representante legal autorizado del sujeto ha proporcionado el consentimiento informado antes de iniciar cualquier actividad o procedimiento específico del estudio cuando el sujeto presenta algún tipo de trastorno que, según el criterio del investigador, impide al sujeto proporcionar su consentimiento informado por escrito.
    *Hombres o mujeres ≥ 18 años de edad.
    *Mieloma múltiple en recaída o progresivo documentado durante o después de cualquier tratamiento (los sujetos refractarios a la línea más reciente de tratamiento son elegibles, a no ser que el último tratamiento contuviera IP o lenalidomida y dexametasona).
    *Los sujetos deben tener como mínimo una RP a al menos 1 línea de tratamiento previa.
    *Los sujetos deben haber recibido entre 1 y 3 líneas de tratamiento previas para el mieloma múltiple (el tratamiento de inducción seguido de trasplante de células madre y tratamiento de consolidación/mantenimiento se considerará como 1 línea de tratamiento). Consulte el apartado 12.8 para obtener directrices para documentar el tratamiento previo.
    *El tratamiento previo con IP o lenalidomida y dexametasona está permitido, siempre que el paciente haya experimentado como mínimo una RP al tratamiento más reciente con IP o lenalidomida y dexametasona, no fuera retirado debido a toxicidad y tenga un intervalo de como mínimo 6 meses sin tratamiento con IP o lenalidomida y dexametasona desde la última dosis recibida hasta el primer tratamiento del estudio. (Los pacientes pueden recibir tratamiento de mantenimiento con lenalidomida durante este intervalo de 6 meses sin tratamiento con IP o lenalidomida y dexametasona.)
    *El tratamiento previo con un régimen que contenga lenalidomida y dexametasona está permitido, siempre que el sujeto no haya progresado durante los primeros 3 meses después de iniciar un tratamiento que contenga lenalidomida y dexametasona.
    *Enfermedad medible con, como mínimo, 1 de los siguientes parámetros evaluados durante los 21 días previos a la aleatorización:
    •Mieloma múltiple de tipo IgG: nivel de proteína monoclonal en suero (proteína M) ≥ 1,0 g/dl.
    •Mieloma múltiple de tipo IgA, IgD, IgE: nivel de proteína M en suero ≥ 0,5 g/dl.
    •Proteína M en orina ≥ 200 mg en 24 horas.
    •En sujetos sin proteína M medible en suero u orina, cadena ligera libre en suero (SFLC) ≥ 100 mg/l (cadena ligera afectada) y una proporción kappa lambda anormal en suero.
    *Estado funcional (EF) del Eastern Cooperative Oncology Group (ECOG) de 0 ≤ 2 (consulte el apartado 12.9).
    E.4Principal exclusion criteria
    Disease-related
    *Waldenström macroglobulinemia.
    *Multiple myeloma of IgM subtype.
    *POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal
    protein, and skin changes).
    *Plasma cell leukemia (> 2.0 × 109/L circulating plasma cells by standard
    differential).
    *Primary amyloidosis (patients with multiple myeloma with asymptomatic
    deposition of amyloid plaques found on biopsy would be eligible if all other
    criteria are met).
    *Myelodysplastic syndrome.
    Other Medical Conditions
    *History of other malignancy within the past 5 years, with the following exceptions:
     Malignancy treated with curative intent and with no known active disease
    present for ≥ 3 years before enrollment and felt to be at low risk for
    recurrence by the treating physician
     Adequately treated non-melanoma skin cancer or lentigo maligna without
    evidence of disease
     Adequately treated cervical carcinoma in situ without evidence of disease
     Adequately treated breast ductal carcinoma in situ without evidence of
    disease
     Prostatic intraepithelial neoplasia without evidence of prostate cancer
     Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in
    situ
     Treated medullary or papillary thyroid cancer
     Similar neoplastic conditions with an expectation of > 95% 5-year
    disease-free survival
    *Known HIV infection, hepatitis C infection (subjects with hepatitis C that achieve
    a sustained virologic response after antiviral therapy are allowed), or hepatitis B
    infection (subjects with hepatitis B surface antigen or core antibody that achieve
    sustained virologic response with antiviral therapy are allowed). Tests to be
    performed if required per local country regulations.
    *Ongoing graft-vs-host disease.
    *Acute active infection requiring systemic antibiotics, antifungal, antiviral (except
    antiviral therapy directed at hepatitis B) agents within 14 days prior to
    randomization.
    *Known cirrhosis.
    *Significant neuropathy (grades 3 to 4, or grade 2 with pain) within 14 days prior
    to randomization.
    *Subjects with pleural effusions requiring thoracentesis or ascites requiring
    paracentesis within 14 days prior to randomization.
    Cardiopulmonary Conditions
    *Uncontrolled hypertension, defined as an average systolic blood pressure
    ≥ 160 mmHg or diastolic ≥ 100 mmHg despite optimal treatment (measured
    following European Society of Hypertension/European Society of Cardiology
    2013 guidelines; Section 12.10).
    *Active congestive heart failure (New York Heart Association Class III to IV),
    symptomatic ischemia, uncontrolled arrhythmias, screening ECG with corrected
    QT interval (QTc) of > 470 msec, pericardial disease, or myocardial infarction
    within 4 months prior to randomization.
    *Intolerance to hydration due to pre-existing pulmonary or cardiac impairment.
    *History of interstitial lung disease or ongoing interstitial lung disease.
    Prior/Concomitant Therapy
    *Immunotherapy within 21 days prior to randomization.
    *Monoclonal antibody therapy within 21 days prior to randomization.
    *Chemotherapy with approved anticancer therapeutic within 21 days prior to
    randomization.
    *Glucocorticoid therapy within 14 days prior to randomization that exceeds a
    cumulative dose of 160 mg of dexamethasone or equivalent dose of other
    corticosteroids.
    *Focal radiation therapy within 7 days prior to randomization. Radiation therapy to
    an extended field involving a significant volume of bone marrow within 21 days
    prior to randomization (ie, prior radiation must have been to < 30% of the bone
    marrow).
    *Major surgery (except kyphoplasty) within 28 days prior to randomization.
    *Autologous or allogeneic stem cell transplant within 90 days prior to
    randomization.
    *Contraindication or intolerance to lenalidomide, dexamethasone, or carfilzomib.
    *Known history of allergy to Captisol (a cyclodextrin derivative used to solubilize
    carfilzomib).
    *Subject has known hypersensitivity to any of the products or components to be
    administered during dosing, including hypersensitivity to antiviral drugs.
    Prior/Concurrent Clinical Study Experience
    *Currently receiving treatment in another investigational device or drug study, or
    < 28 days since ending treatment on another investigational device or drug
    study(ies).
    Organ Function Assessments
    *Hepatic dysfunction within 21 days prior to randomization:
     bilirubin  1.5x the upper limit of normal (ULN)
     aspartate aminotransferase (AST) or alanine aminotransferase (ALT)  2.5x
    ULN
    *Left ventricular ejection fraction < 40% assessed by transthoracic
    echocardiogram (ECHO).
    *Absolute neutrophil count (ANC) < 1 x 109/L within 21 days prior to
    randomization. Screening ANC should be independent of growth factor support
    for ≥ 1 week.
    *Relacionados con la enfermedad*
    Macroglobulinemia de Waldenström
    Mieloma múltiple de subtipo IgM
    Síndrome de POEMS
    Leucemia de células plasmáticas(>2,0x109/l de células plasmáticas circulantes mediante diferencial estándar)
    Amiloidosis primaria (los pacientes con mieloma múltiple y una acumulación asintomática de placas amiloides observada en una biopsia podrían ser elegibles si cumplen el resto de criterios)
    Síndrome mielodisplásico
    *Otras enfermedades*
    Ante. de otras neoplasias malignas en los últimos 5 años, con las excepciones siguientes
    •Tumor maligno tratado con intención curativa y sin presencia de enfermedad activa confirmada durante≥3 años antes de la inclusión y que el médico encargado del trm considere de bajo riesgo de recurrencia
    •Cáncer de piel no melanomatoso o lentigo maligno trtd adecuadamente sin evidencia de enfermedad
    •Carcinoma insitu de cuello uterino trtd adecuadamente sin evidencia de enfermedad
    •Carcinoma ductal in situ de mama trtd adecuadamente sin evidencia de enfermedad
    •Neoplasia intraepitelial prostática sin evidencia de cáncer de próstata
    •Carcinoma urotelial papilar no invasivo o carcinoma insitu tratados adecuadamente
    •Cáncer papilar o medular de tiroides trtd
    •Una enfermedad neoplásica similar con expectativa de>95%de supervivencia libre de enfermedad durante5años
    Infección conocida por el VIH,infección por hepatitisC(los sujetos con hepatitisC que alcanzan una respuesta virológica sostenida después del trm antivírico sí están permitidos) o infección por hepatitis B (los sujetos con antígeno de superficie de la hepatitisB o anticuerpo core que alcanzan una respuesta virológica sostenida con trm antivírico sí están permitidos).Si es necesario se deben realizar pruebas según las normativas locales
    Enfermedad del injerto contra el huésped en curso
    Infección activa aguda que requiera antibióticos,antifúngicos,agentes antivíricos(salvo tratamiento antivírico destinado a la hepatitisB)sistémicos en los14días previos a la aleatorización
    Cirrosis conocida
    Neuropatía significativa(grados3a4,o grado2 con dolor)en los14días previos a la aleatorización
    Sujetos con derrames pleurales que requieran toracocentesis o con ascitis que requiera paracentesis en los14días previos a la aleatorización
    *Enfermedades cardiopulmonares*
    Hipertensión no controlada, definida como el promedio de la PA sistólica≥160mmHg o diastólica≥100mmHg a pesar de un tratamiento óptimo(determinada según las directrices de2013de la SociedadEuropeadeHipertensión/SociedadEuropeadeCardiología;apartado12.10)
    Insuficiencia cardíaca congestiva activa(de claseIII a IV, según la NewYorkHeartAssociation), isquemia sintomática, arritmias no controladas,ECG de selección con un intervalo QTcorregido> 470ms,enfermedad del pericardio o infarto de miocardio durante los4meses previos a la aleatorización
    Intolerancia a la hidratación debido a un deterioro pulmonar o cardíaco ya existente
    Ante. de enfermedad pulmonar intersticial o en curso
    *Trm previo/concomitante*
    Inmunoterapia en los21días previos a la aleatorización
    Trm con anticuerpos monoclonales en los21días previos a la aleatorización
    Quimioterapia con un agente terapéutico anticanceroso aprobado en los 21días previos a la aleatorización.
    Trm con glucocorticoides en los14días previos a la aleatorización que supere una dosis acumulativa de160mg de dexametasona o una dosis equivalente de otros corticosteroides
    Radioterapia focal en los7días previos a la aleatorización.Radioterapia ampliada del campo con afectación de un volumen significativo de médula ósea en los21días previos a la aleatorización(es decir, la irradiación previa debe haber sido<30%de la médula ósea)
    Cirugía mayor(salvo cifoplastia) en los28días previos a la aleatorización
    Traspl. autólogo o alogénico de células progenitoras en los90días previos a la aleatorización
    Contraindicación o intolerancia a lenalidomida, dexametasona o carfilzomib
    Ante. conocidos de alergia a Captisol(un derivado de la ciclodextrina utilizado para solubilizar carfilzomib)
    El sujeto presenta hipersensibilidad conocida a alguno de los productos o componentes que se deben administrar durante el trm, incluida la hipersensibilidad a fármacos antivíricos
    Experiencia previa/concomitante en ensayos clínicos
    Estar recibiendo trm en otro estudio de un fármaco o dispositivo en investigación o haber transcurrido<28días desde el fin del trm en otro estudio de un fármaco o dispositivo en investigación
    *Evaluaciones de la función orgánica*
    Disfunción hepática en los21días previos a la aleatorización
    •Bilirrubina≥1,5veces el límite superior de la normalidad
    •Aspartato aminotransferasa y alanina aminotransferasa≥2,5veces el LSN
    Fracción de eyección ventricular izquierda<40%,determinada con un ecocardiograma transtorácico
    Recuento absoluto de neutrófilos<1x109/l en los21días previos a la aleatorización.El RAN de la selección debe ser independiente del tratamiento de apoyo con factor de crecimiento durante≥1sem
    E.5 End points
    E.5.1Primary end point(s)
    overall response rate (ORR, defined
    as the proportion of best overall
    response of stringent complete
    response [sCR], complete response
    [CR], very good partial response
    [VGPR], and partial response [PR] per
    International Myeloma Working Group
    Uniform Response Criteria [IMWG-URC]) over the duration of the study
    Indice de Respuesta General (ORR, definido como la proporción entre la mejor respuesta general estricta completa [sCR], la respuesta completa [CR], la respuesta parcial muy buena [VGPR] y la respuesta parcial [PR] según los Criterios de Respuesta Uniforme del Grupo Internacional Especializado en Mieloma [IMWG-URC]) durante la duración del estudio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Over the duration of the study
    Por encima de la duración del estudio
    E.5.2Secondary end point(s)
    *1-year PFS
    *convenience as measured by the
    Patient-reported Convenience With
    Carfilzomib-dosing Schedule Question
    after cycle 4 of treatment
    *1 año PFS
    *la comodidad es medida a partir del cuestionario de comodidad del paciente con el horario de dosis de Carfilzomib despues de 4 ciclos de tratamiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    *1-year PFS
    *convenience as measured by the
    Patient-reported Convenience With
    Carfilzomib-dosing Schedule Question
    after cycle 4 of treatment
    *1 año PFS
    *la comodidad es medida a partir del cuestionario de comodidad del paciente con el horario de dosis de Carfilzomib despues de 4 ciclos de tratamiento.
    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) 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 Yes
    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) 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA47
    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
    Bulgaria
    Canada
    Czech Republic
    France
    Germany
    Greece
    Japan
    Korea, Republic of
    Netherlands
    Romania
    Russian Federation
    Spain
    Sweden
    Turkey
    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
    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 months3
    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: 230
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 230
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 254
    F.4.2.2In the whole clinical trial 460
    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
    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 Decision2019-03-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-08
    P. End of Trial
    P.End of Trial StatusOngoing
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