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    Summary
    EudraCT Number:2016-002584-33
    Sponsor's Protocol Code Number:CINC424C2301
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-11-17
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2016-002584-33
    A.3Full title of the trial
    A phase III randomized open-label multi-center study of ruxolitinib vs. best available therapy in patients with corticosteroid-refractory acute graft vs. host disease after allogenic stem cell transplantation
    Estudio de fase III, aleatorizado, abierto y multicéntrico de ruxolitinib frente a la mejor terapia disponible en pacientes con enfermedad de injerto contra huésped aguda y refractaria a corticosteroides en trasplante alogénico de progenitores hematopoyéticos
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and efficacy of ruxolitinib versus best available therapy in patients with corticosteroid-refractory acute graft vs. host disease after allogeneic stem cell transplantation
    Estudio de eficacia y seguridad de Ruxolitinib frente a la mejor terapia disponible (BAT) en pacientes con enfermedad de injerto contra huésped aguda y refractaria a esteroides de Grado II-IV
    A.4.1Sponsor's protocol code numberCINC424C2301
    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 SponsorNovartis Farmacéutica S.A.
    B.1.3.4CountrySpain
    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 supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmacéutica, S.A.
    B.5.2Functional name of contact pointDepartamento Médico (ICRO)
    B.5.3 Address:
    B.5.3.1Street AddressGran Vía de les Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number+ 34 90 0353036
    B.5.5Fax number+ 34 93 2479903
    B.5.6E-maileecc.novartis@novartis.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 Jakavi
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRuxolitinib
    D.3.2Product code INC424
    D.3.4Pharmaceutical form Tablet
    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 INNruxolitinib
    D.3.9.1CAS number 1092939-17-7
    D.3.9.2Current sponsor codeINC424
    D.3.9.3Other descriptive nameRUXOLITINIB PHOSPHATE
    D.3.9.4EV Substance CodeSUB32897
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) 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
    corticosteroid-refractory acute graft vs. host disease after allogeneic stem cell transplantation
    Enfermedad de injerto contra huésped aguda y refractaria a corticosteroides en trasplante alogénico de progenitores hematopoyéticos
    E.1.1.1Medical condition in easily understood language
    acute Graft versus host disease
    enfermedad de injerto contra huésped aguda
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10066260
    E.1.2Term Acute graft versus host disease
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10066262
    E.1.2Term Acute graft versus host disease in skin
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10066264
    E.1.2Term Acute graft versus host disease in intestine
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10066263
    E.1.2Term Acute graft versus host disease in liver
    E.1.2System Organ Class 10021428 - Immune 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
    The main objective of the trial is to compare the efficacy of ruxolitinib with best available therapy in patients with corticosteroid refractory acute Graft vs. Host Disease by assessing the overall response rate (either complete or partial response without requiring additional systemic therapies) based on organ stage scoring.
    El objetivo principal del ensayo es comparar la eficacia de ruxolitinib frente a la Mejor Terapia Disponible en pacientes con
    Enfermedad de injerto contra huésped aguda y refractaria a
    esteroides evaluando la Tasa de Respuesta Global (respuesta completa o respuesta parcial sin necesidad de terapias
    sistémicas adicionales) basado en el estadio del órgano
    E.2.2Secondary objectives of the trial
    The key secondary objectif of the trial is to measure the durable response rate of patients who are corticosteroid refractory acute graft vs. host disease and to compare those patients treated with ruxolitinib vs. best available therapy.
    The other secondary objectives relate to further measurements comparing patients treated with ruxolitinib vs. best available therapy:
    Their survival over a 2 year time period.
    Whether steroids are successfully tapered to lower doses.
    Whether they develop chronic graft vs. host disease, and other standard transplant outcomes including control of their underlying hematologic disease for which the transplant was performed.
    The safety of ruxolitinib and best available therapy.
    Measurements of each patient’s reported quality of life will be compared in patients treated with ruxolitinib vs. best available therapy for their corticosteroid refractory acute graft vs. host disease.
    Medir la tasa de respuesta duradera de los pacientes con enfermedad de injerto contra huésped aguda y refractaria a corticosteroides y comparar aquellos pacientes tratados con ruxolitinib frente a la mejor terapia disponible.
    Los otros objetivos secundarios se refieren a otras mediciones que comparan a los pacientes tratados con ruxolitinib frente a la mejor terapia disponible:
    Supervivencia durante un período de tiempo de 2 años.
    Si los esteroides se reducen con éxito a dosis más bajas.
    Si desarrollan enfermedad crónica de injerto contra huésped, y otros resultados estándar de trasplante, incluyendo el control de la enfermedad hematológica subyacente para la que se realizó el trasplante.
    La seguridad de ruxolitinib y la mejor terapia disponible.
    Las mediciones de la calidad de vida de cada paciente se compararán en pacientes tratados con ruxolitinib frente a la mejor terapia disponible para su enfermedad de injerto contra huésped aguda y refractaria a corticosteroides.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Have undergone alloSCT from any donor source (matched unrelated donor, sibling, haplo-identical) using bone marrow, peripheral blood stem cells, or
    cord blood. Recipients of non- myeloablative, myeloablative, and reduced intensity conditioning are eligible
    - Clinically diagnosed Grades II to IV acute GvHD as per standard criteria occurring after alloSCT requiring systemic immune suppressive
    therapy. Biopsy of involved organs with aGvHD is encouraged but not required for study screening.
    - Confirmed diagnosis of corticosteroid refractory aGvHD (confirmed within 48h prior to study treatment start) defined as:
    • Patients administered high-dose systemic corticosteroids (methylprednisolone 2 mg/kg/day [or equivalent prednisone dose 2.5 mg/kg/day]), given alone or combined with calcineurin inhibitors (CNI) and either:
    • Progressing based on organ assessment after 5 days compared to organ stage at the time of initiation of high-dose systemic corticosteroid +/- CNI for the treatment of Grade II-IV aGvHD,
    OR
    • Failure to achieve at a minimum partial response based on organ assessment after 7 days compared to organ stage at the time of initiation of high-dose systemic corticosteroid +/- CNI for the treatment of Grade II-IV aGvHD,
    OR
    • Patients who fail corticosteroid taper defined as fulfilling either one of the following criteria:
    • Requirement for an increase in the corticosteroid dose to methylprednisolone ≥2 mg/kg/day (or equivalent prednisone dose ≥2.5 mg/kg/day)
    OR
    • Failure to taper the methylprednisolone dose to <1 mg/kg/day (or equivalent prednisone dose <1.25 mg/kg/day) for a minimum 7 days.
    - Que hayan sido sometidos a trasplante alogénico de
    progenitores hematopoyéticos (alloSCT) de cualquier fuente de
    donante (donante compatible no emparentado, hermano,
    haploidéntico) utilizando médula ósea, células progenitoras
    hematopoyéticas de sangre periférica, o sangre de cordón
    umbilical. Los receptores de trasplante no mieloablativo,
    mieloablativo y de intensidad reducida son elegibles.
    -Diagnosticados clínicamente de GvHD agudo de Grados II a IV
    según criterios estándar que aparece tras alloSCT
    que precisa terapia inmunosupresora sistémica. Se recomienda
    la biopsia de los órganos implicados con aGvHD, pero no es
    necesario para la selección del estudio.
    -Diagnóstico confirmado de aGvHD refractario a esteroides
    (confirmado en las 48h previas al inicio del tratamiento del
    estudio) definido como pacientes que han recibido dosis altas de
    corticosteroides sistémicos (metilprednisolona 2 mg/kg/día [o
    dosis equivalente de prednisona 2.5 mg/kg/día]), administrado
    solo o en combinación con inhibidores de calcineurina (CNI) y
    cualquiera de los siguientes:
    A. Progresión basada en la evaluación del órgano después de 5
    días en comparación con el estadio del órgano en el momento
    del inicio de esteroides sistémicos a dosis altas +/- CNI para
    el tratamiento de aGvHD de Grado II-IV,
    O
    B. Fallo en alcanzar como mínimo una respuesta parcial en base
    a la evaluación del órgano después de 7 días en comparación
    con el estadio del órgano en el momento del inicio de
    esteroides sistémicos a dosis altas +/- CNI para el tratamiento
    de aGvHD de Grado II-IV,
    O
    C. Pacientes en quienes no funciona la disminución progresiva
    de corticosteroides definidos como los que cumplen alguno
    de los siguientes criterios:
    1. Precisar un aumento de la dosis de corticosteroides a
    metilprednisolona >/= 2 mg/kg/día (o dosis equivalente de
    prednisona >/= 2,5 mg/kg/día), O
    2. Fallo al disminuir la dosis de metilprednisolona a < 1
    mg/kg/día (o dosis equivalente de prednisona < 1,25
    mg/kg/día) durante un mínimo de 7 días
    E.4Principal exclusion criteria
    - Has received more than one systemic treatment for aGvHD, other than corticosteroids +/- CNI (prophylaxis or treatment).
    - Clinical presentation resembling de novo chronic GvHD or GvHD overlap syndrome with both acute and chronic GvHD features (as defined by Jagasia, et al. 2015)
    - Presence of an active uncontrolled infection including significant bacterial, fungal, viral or parasitic infection requiring treatment. Infections are considered controlled if appropriate therapy has been instituted and, at the time of screening, no signs of progression are present. Progression of infection is defined as hemodynamic instability attributable to sepsis, new symptoms, worsening physical signs or radiographic findings attributable to infection.
    Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
    - Evidence of active viral infection (confirmed by peripheral blood viral load) including CMV, EBV, HHV-6, HBV, or HCV. Patients with pre-transplant positive serology results indicative of high risk for viral reactivation must have negative viral load results within 28 days prior to randomization. Patients whose immune status is unknown or uncertain (e.g. serologies not obtained prior to transplant) must have viral load results confirming no evidence of active viral infection within 28 days prior to randomization.
    - Presence of relapsed primary malignancy, or who have been treated for relapse after the alloHSCT was performed, or who may require rapid immune suppression withdrawal as pre-emergent treatment of early malignancy relapse.
    Other protocol-defined inclusion/exclusion criteria may apply.
    - Ha recibido más de un tratamiento sistémico para aGvHD aparte
    de corticosteroides +/- CNI (profilaxis o tratamiento).
    - Presentación clínica asimilable a GvHD crónico de novo o
    síndrome de superposición a GvHD con rasgos de GvHD agudo
    y crónico (según definido por Jagasia et al. 2015).
    - Presencia de una infección no controlada activa incluyendo
    infección significativa bacteriana, fúngica, vírica o parasitaria que
    precisa tratamiento. Las infecciones se consideran controladas si
    se ha instituido terapia adecuada y, en el momento de la
    selección, no hay presencia de signos de progresión. La
    progresión de la infección se define como inestabilidad
    hemodinámica atribuible a sepsis, nuevos síntomas, signos de
    empeoramiento físico o hallazgos radiológicos atribuibles a
    infección. Fiebre persistente sin otros signos o síntomas no se
    interpretará como progresión de la infección.
    - Evidencia de infección vírica activa (confirmada por carga viral en
    sangre periférica) incluyendo CMV, EBV, HHV-6, HBV, o HCV.
    Los pacientes con resultados de serología positiva pre-trasplante
    indicativa de elevado riesgo de reactivación vírica deben tener
    resultados de carga viral negativa en los 28 días previos a la
    aleatorización. Los pacientes cuya situación inmunológica sea
    desconocida o incierta (p.ej., serologías no obtenidas antes del
    trasplante) deben tener resultados de carga viral que confirmen
    no evidencia de infección vírica activa en los 28 días previos a la
    aleatorización.
    - Presencia de recaída del tumor, o que haya sido tratado para la
    recaída después de haber realizado el trasplante alogénico o
    que pueden precisar retirada rápida de la inmunosupresión como
    tratamiento previo a la aparición de recaída prematura de tumor
    primario.
    Otros criterios de inclusión/exclusión definidos en el protocolo pueden aplicar.
    E.5 End points
    E.5.1Primary end point(s)
    Overall Response Rate (ORR)
    • ORR is defined as the proportion of patients with a best overall response defined as complete response or partial response without requirement for additional systemic therapy for an early progression, mixed response, or non response.
    Tasa de Respuesta Global (ORR)
    - ORR se define como la proporción de pacientes con la mejor respuesta global definida como respuesta completa o respuesta parcial sin necesidad de terapias sistémicas adicionales por una progresión prematura, respuesta mixta o sin respuesta.
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 Days
    28 Días
    E.5.2Secondary end point(s)
    1. Durable Overall Response Rate
    o Proportion of all patients in each arm who achieve a complete response (CR) or partial response (PR) at Day 28 and maintain a CR or PR at Day 56.
    2. ORR
    o Proportion of patients who achieved ORR (CR+PR) at Day 14, Day 56.
    3. Duration of response
    o DOR is the time from first response until aGvHD progression or the date of additional systemic therapies for aGvHD.
    4. Cumulative steroid dose
    o Weekly cumulative steroid dose for each subject up to Day 56 or end of treatment
    5. Overall Survival (OS)
    o OS is defined as the time from the date of randomization to the date of death due to any cause.
    6. Event-free survival
    o Event-free survival, defined as the time from the date of randomization to the date of hematologic disease relapse/progression, graft failure, or death due to any cause.
    7. Failure-Free survival (FFS)
    o FFS is defined as the time from the date of randomization to date of hematologic disease relapse/progression, non- relapse mortality, or addition of new systemic aGvHD treatment.
    8. Non Relapse Mortality (NRM)
    o NRM is defined as the time from date of randomization to date of death not preceded by hematologic disease relapse/progression
    9. Malignancy Relapse/Progression (MR)
    o MR is defined as the time from date of randomization to hematologic malignancy relapse/progression.
    Calculated for patients with underlying hematologic malignant disease.
    10. Incidence of cGvHD
    o cGvHD, defined as the diagnosis of any cGvHD including mild, moderate, severe
    11. Pharmacokinetics (PK) of ruxolitinib in Steroid Refractory -acute GvHD patients
    o Ruxolitinib plasma concentrations after a single dose and at steady state.
    12. Exposure-response relationship of ruxolitinib in SR-aGvHD
    o Pharmacokinetics (exposure) and efficacy (ORR, OS) relationship. Pharmacokinetics (exposure) and safety (AEs) relationship.
    13. Patient Reported Outcomes (PROs): Change in FACT-BMT from baseline, only in adults
    14. Patient Reported Outcomes (PROs): Change in EQ-5D from baseline
    1. Tasa de Respuesta Global duradera
    2. ORR
    3. Duración de respuesta
    4. Dosis acumulada de esteroides
    5. Supervivencia Global (OS)
    6. Supervivencia Libre de Acontecimientos
    7. Supervivencia Libre de Fallo (FFS)
    8. Mortalidad Sin Recidivas (NRM)
    9. Recidiva/Progresión de la Enfermedad (MR)
    10. Incidencia de cGvHD
    11.Farmacocinética (PK) de ruxolitinib en pacientes SRaGvHD
    12. Relación exposición-respuesta de ruxolitinib en SRaGvHD
    13. Resultados Notificados por el Paciente
    (PROs): cambio en FACT-BMT desde momento basal, sólo en adultos
    14. Resultados Notificados por el Paciente
    (PROs): cambio en EQ-5D desde el momento basal
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Day 56
    2. Day 14, Day 56
    3. Up to 24 weeks
    4. 56 Days
    5. Up to 24 months
    6. Up to 24 months
    7. Up to 24 months
    8. Up to 24 months
    9. Up to 24 months
    10. Up to 24 months
    11. 168 Days
    12. 168 Days
    13. Baseline, Up to 30 day follow-up visit
    14. Baseline, Up to 30 day follow-up visit
    1. Día 56
    2. Día 14, día 56
    3. Hasta 24 semanas
    4. 56 Días
    5. Hasta 24 meses
    6. Hasta 24 meses
    7. Hasta 24 meses
    8. Hasta 24 meses
    9. Hasta 24 meses
    10. Hasta 24 meses
    11. 168 Días
    12. 168 Días
    13. Basal, hasta visita de seguimiento día 30
    14. Basal, hasta visita de seguimiento día 30
    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 No
    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) 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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    Mejor Terapia Disponible (BAT)
    Best available therapy (BAT)
    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 EEA54
    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
    Austria
    Canada
    France
    Germany
    Hong Kong
    Israel
    Italy
    Japan
    Korea, Republic of
    Norway
    Saudi Arabia
    Spain
    Sweden
    Taiwan
    United Kingdom
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    End of Study (EoS) will occur when all patients have reached Month 24 (i.e., the end of the long-term follow-up observation period), unless the patient withdraws consent.
    El final del estudio (EoS) ocurrirá cuando todos los pacientes hayan alcanzado el Mes 24 (es decir el final del periodo de observación del seguimiento a largo plazo) a no ser que el paciente retire el consentimiento.
    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 months6
    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
    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: 15
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 15
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 281
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 206
    F.4.2.2In the whole clinical trial 308
    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)
    No plans for treatment or care after completion of participation in the trial.
    No hay planes para tratamiento o cuidado después de completar la participación en el estudio.
    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 Decision2017-02-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-04-23
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