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    Summary
    EudraCT Number:2018-000390-67
    Sponsor's Protocol Code Number:ACT15377
    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:2018-06-27
    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 number2018-000390-67
    A.3Full title of the trial
    A Phase 1/2 open-label, multi-center, safety, preliminary efficacy and pharmacokinetic (PK) study of isatuximab (SAR650984) in combination with atezolizumab or isatuximab alone in patients with advanced malignancies
    Estudio en fase 1/2, abierto, multicéntrico, para evaluar la seguridad, eficacia preliminar y farmacocinética de isatuximab (SAR650984) en combinación con atezolizumab o solo isatuximab en pacientes con enfermedades malignas avanzadas
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety, Preliminary Efficacy and PK of Isatuximab (SAR650984) Alone or in Combination with Atezolizumab in Patients with Advanced Malignancies
    Seguridad, eficacia preliminar y farmacocinética de isatuximab (SAR650984) en combinación con atezolizumab o solo isatuximab en pacientes con enfermedades malignas avanzadas
    A.4.1Sponsor's protocol code numberACT15377
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1202-0839
    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 SponsorSanofi-aventis recherche & développement
    B.1.3.4CountryFrance
    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 supportSanofi-aventis recherche & développement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi-aventis, s.a.
    B.5.2Functional name of contact pointUnidad Estudios Clínicos
    B.5.3 Address:
    B.5.3.1Street Addressc/ Josep Pla nº2, 4ª planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08019
    B.5.3.4CountrySpain
    B.5.4Telephone number93 485 94 00
    B.5.6E-mailES-unidadestudiosclinicos@sanofi.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 nameisatuximab
    D.3.2Product code SAR650984
    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 INNisatuximab
    D.3.9.2Current sponsor codeSAR650984
    D.3.9.4EV Substance CodeSUB119676
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 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 Tecentriq
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration 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 nameatezolizumab
    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 INNATEZOLIZUMAB
    D.3.9.3Other descriptive nameTecentriq
    D.3.9.4EV Substance CodeSUB178312
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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
    Neoplasm
    Neoplasias
    E.1.1.1Medical condition in easily understood language
    Neoplasm
    Neoplasias
    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 PT
    E.1.2Classification code 10028980
    E.1.2Term Neoplasm
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    -Phase1: To characterize the safety and tolerability of isatuximab in combination with atezolizumab in participants with unresectable hepatocellular carcinoma (HCC), platinum-refractory recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN), platinumresistant/ refractory epithelial ovarian cancer (EOC), or recurrent glioblastoma multiforme (GBM), and to determine the recommended Phase 2 dose (RP2D).
    - Phase2: To assess response rate (RR) of isatuximab in combination with atezolizumab in participants with HCC or SCCHN or EOC.
    - Phase2: To assess the progression free survival rate at 6 months (PFS-6) of isatuximab in combination with atezolizumab, or as a single agent in participants with GBM.
    Fase 1: Caracterizar la seguridad y la tolerabilidad de isatuximab en combinación con atezolizumab en participantes con carcinoma hepatocelular (CHC) irresecable, carcinoma de células escamosas de cabeza y cuello (CCECC) metastásico/recurrente refractario al platino, cáncer epitelial de ovario (CEO) refractario/resistente al platino, o glioblastoma multiforme (GBM) recurrente, y determinar la dosis recomendada para la fase 2 (DRF2)
    Fase 2: Evaluar la tasa de respuesta (TR) de isatuximab en combinación con atezolizumab en participantes con CHC o CCECC o CEO
    Fase 2: evaluar la tasa de supervivencia sin progresión a los 6 meses (SSP-6) de isatuximab en combinación con atezolizumab, o como agente único en participantes con GBM
    E.2.2Secondary objectives of the trial
    -To evaluate the safety profile of isatuximab monotherapy (GBM only), or in combination with atezolizumab in Phase 2.
    -To evaluate the immunogenicity of isatuximab and atezolizumab
    -To characterize the pharmacokinetic (PK) profile of isatuximab single agent (GBM only) and atezolizumab in combination with isatuximab.
    -To assess the overall efficacy of isatuximab in combination with atezolizumab, or single agent (GBM only).
    - Evaluar el perfil de seguridad (en la Fase 2) de isatuximab en monoterapia (solo GBM), o en combinación con atezolizumab
    - Evaluar la inmunogenicidad de isatuximab y atezolizumab
    - Caracterizar el perfil farmacocinético (FC) de isatuximab como agente único (solo GBM) y de atezolizumab en combinación con isatuximab.
    - Evaluar la eficacia general de isatuximab en combinación con atezolizumab, o como agente único (solo GBM)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients must have a known diagnosis of either unresectable hepatocellular carcinoma (HCC), platinum-refractory recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN), platinum-resistant/refractory epithelial ovarian cancer (EOC) with evidence of measurable disease
    or recurrent glioblastoma multiforme (GBM).
    - ≥18 years of age.
    -For patients with HCC: Documentation of progressive disease (PD) during or after treatment with either sorafenib or lenvatinib, or intolerance to the therapy.
    -For patients with SCCHN: Received and failed up to 2 lines of prior systemic anti-cancer therapy with documentation of tumor recurrence or PD within 6 months of last platinum-based therapy in primary, recurrent, or metastatic setting.
    -For patients with EOC: Received and failed up to 3 lines of prior platinum-containing therapy when the disease was platinum-sensitive, and the patients should not have received any systemic therapy for platinum-resistant/refractory disease.
    -For patients with GBM: Documentation of PD or first recurrence during or after temozolomide maintenance therapy for newly diagnosed GBM treated with 1st line radiotherapy plus concurrent temozolomide.
    - Los pacientes deben tener un diagnóstico conocido de carcinoma hepatocelular (CHC) irresecable, carcinoma de células escamosas de cabeza y cuello (CCECC) metastásico/recurrente refractario al platino, cáncer epitelial de ovario (CEO) refractario/resistente al platino, o glioblastoma multiforme (GBM) recurrente
    - Superior o igual a 18 años de edad.
    -Para pacientes con CHC: Documentación de enfermedad progresiva (EP) durante o después del tratamiento con sorafenib o lenvatinib, o intolerancia a la terapia.
    -Para pacientes con CCECC: Recibieron y fallaron hasta 2 líneas de terapia anticancerígena sistémica anterior con documentación de recurrencia tumoral o EP dentro de los 6 meses posteriores a la última terapia basada en platino en entornos primarios, recurrentes o metastásicos.
    -Para pacientes con CEO: Recibieron y fallaron hasta 3 líneas de terapia previa que contenía platino cuando la enfermedad era sensible al platino, y los pacientes no debieron haber recibido ningún tratamiento sistémico para la enfermedad refractario/resistente al platino.
    -Para pacientes con GBM: Documentación de EP o primera recurrencia durante o después del tratamiento de mantenimiento con temozolomida para GBM recién diagnosticada tratada con radioterapia de primera línea más temozolomida concurrente.
    E.4Principal exclusion criteria
    - Prior exposure to agent that blocks CD38 or participation in clinical studies with isatuximab
    - For patients with HCC, SCCHN, EOC or GBM prior exposure to any agent (approved or investigational) that blocks the PD-1/PD-L1 pathway.
    - Evidence of other immune related disease /conditions.
    - History of non-infectious pneumonitis requiring steroids or current pneumonitis; history of the thoracic radiation.
    - Has received a live-virus vaccination within 28 days of planned treatment start. Seasonal flu vaccines that do not contain live virus are permitted.
    - Prior solid organ or bone marrow transplantation.
    - Eastern Cooperative Oncology Group performance status (PS) ≥2 for patients with HCC, SCCHN or EOC or Karnofsky performance score ≤ 70 for patients with GBM
    - Poor bone marrow reserve.
    - Poor organ function.
    - Exposición previa al agente que bloquea CD38 o participación en estudios clínicos con isatuximab
    - Para pacientes con CHC, CCECC, CEO o GBM previa exposición a cualquier agente (aprobado o en investigación) que bloquea la vía PD-1 / PD-L1.
    - Evidencia de otras enfermedades / afecciones relacionadas con el sistema inmune.
    - Antecedentes de neumonitis no infecciosa que requiere esteroides o neumonitis actual; historia de la radiación torácica.
    - Ha recibido una vacuna de virus vivo dentro de los 28 días de iniciado el tratamiento planificado. Se permiten vacunas contra la gripe estacional que no contengan virus vivos.
    - Trasplante de órgano sólido o médula ósea previo.
    - Estado de desempeño del Eastern Cooperative Oncology Group (PS) ≥2 para pacientes con CHC, CCECC, CEO o puntuación de rendimiento de Karnofsky ≤ 70 para pacientes con GBM
    - Pobre reserva de médula ósea.
    - Pobre función del órgano.
    E.5 End points
    E.5.1Primary end point(s)
    1) Dose Limiting Toxicities (DLTs): DLTs as observed during DLT-observation period
    2) Adverse events (AEs): Number of patients with AEs based on standard and systematic assessment including changes in laboratory tests and vital signs, according to the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) version 4.03 Grade scaling
    3) Maximum tolerated dose (MTD): MTD determined during Phase 1
    4) Recommended Phase 2 dose (RP2D): Dose selected for the Phase 2 portion
    5) Response Rate: In patients with unresectable hepatocellular carcinoma (HCC), platinum-refractory recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN), platinumresistant/refractory epithelial ovarian cancer assessed by using RECIST 1.1
    6) Progression free survival: In patients with glioblastoma multiforme (GBM) assessed by using Response Assessment for Neuro-Oncology (RANO) criteria at 6 months
    1) Toxicidad limitante de dosis (TLD): TLD observados durante el período de observación DLT
    2) Acontecimientos adversos (AA): Número de pacientes con AA según la evaluación estándar y sistemática, incluidos los cambios en las pruebas de laboratorio y los signos vitales, según el Instituto Nacional del Cáncer - Criterios de toxicidad comunes (NCI-CTC) versión 4.03 Escalado de grado
    3) Dosis máxima tolerada (DMT): DMT determinada durante la Fase 1
    4) Dosis recomendada de Fase 2 (RP2D): Dosis seleccionada para la parte de Fase 2
    5) Tasa de respuesta: en pacientes con carcinoma hepatocelular (CHC) irresecable, carcinoma de células escamosas de cabeza y cuello (CCECC) metastásico/recurrente refractario al platino, cáncer epitelial de ovario (CEO) refractario/resistente al platino evaluado mediante RECIST 1.1
    6) Supervivencia libre de progresión: en pacientes con glioblastoma multiforme (GBM) recurrente evaluado mediante el uso de los criterios de Evaluación de respuesta para Neuro-Oncología (RANO) a los 6 meses
    E.5.1.1Timepoint(s) of evaluation of this end point
    1), 3) and 4) Up to 3 weeks after first study treatment administration
    2) Up to 90 days after last study treatment administration (Up to approximately 27 months after first study treatment administration)
    5) Up to 6 months after last patient's first treatment in a given cohort
    6) Up to 6 months after last patient's first treatment
    1), 3) y 4) Hasta 3 semanas después de la primera administración del tratamiento del estudio
    2) Hasta 90 días después de la última administración del tratamiento del estudio (Hasta aproximadamente 27 meses después de la administración del primer estudio de tratamiento)
    5) Hasta 6 meses después del primer tratamiento del último paciente en una cohorte dada
    6) Hasta 6 meses después del primer tratamiento del último paciente
    E.5.2Secondary end point(s)
    1) Immunogenicity: isatuximab: Levels of anti-drug antibody against isatuximab
    2) Immunogenicity: atezolizumab: Levels of anti-drug antibody against atezolizumab
    3) Tumor burden change: The best percent-change from baseline in a sum of the diameters (longest for non-nodal lesion, short axis for nodal lesions) for all target lesions in participants with HCC, SCCHN and EOC, and in a sum of products of diameters for all target lesions in participants with GBM.
    4) Disease control rate: The sum of complete responses (CR) + partial responses (PR) + stable disease (SD)
    5) Duration of response: The time from the date of the first response (PR or CR in radiographic objective response) that is subsequently confirmed to the date of first confirmed disease progression or death, whichever occurs first.
    6) Progress free survival: The time from the first study treatment administration to the date of first documentation of progressive disease (RECIST 1.1 for participants with HCC, SCCHN, EOC and RANO criteria for participants with GBM) or the date of death from any cause
    7) Response Rate: In GBM assessed by RANO criteria
    8) Pharmacokinetic (PK) parameters: Area under the curve (AUC0-T): AUC is the area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval (T; i.e., 7 days for isatuximab)
    9) Assessment of PK parameter: Cmax: Cmax is maximum drug concentration observed
    10) Assessment of PK parameter: tmax : Time to reach Cmax
    1) Inmunogenicidad: isatuximab: niveles de anticuerpos antifármaco contra isatuximab
    2) Inmunogenicidad: atezolizumab: niveles de anticuerpos antifármaco contra atezolizumab
    3) Cambio de la carga tumoral: el mejor porcentaje de cambio desde la basal en una suma de los diámetros (más largo para lesión no-nodal, eje corto para lesiones nodales) para todas las lesiones diana en participantes con CHC, CCECC, CEO , y en una suma de productos de diámetros para todas las lesiones diana en participantes con GBM.
    4) Tasa de control de la enfermedad: suma de respuestas completas (RC) + respuestas parciales (RP) + enfermedad estable (ES)
    5) Duración de la respuesta: el tiempo transcurrido desde la fecha de la primera respuesta (RP o RC en la respuesta objetiva radiográfica) que se confirma posteriormente hasta la fecha de la primera progresión confirmada de la enfermedad o la muerte, lo que ocurra primero.
    6) Supervivencia libre de progresión: el tiempo desde la primera administración del tratamiento del estudio hasta la fecha de la primera documentación de enfermedad progresiva (RECIST 1.1 para participantes con criterios CHC, CCECC, CEO y RANO para participantes con GBM) o la fecha de muerte por cualquier causa
    7) Tasa de respuesta: En GBM evaluada por los criterios de RANO
    8) Parámetros farmacocinéticos (PK): área bajo la curva (AUC0-T): AUC es el área bajo la curva de concentración plasmática versus tiempo calculada usando el método trapezoidal durante el intervalo de dosificación (T, es decir, 7 días para isatuximab)
    9) Evaluación del parámetro PK: Cmax: Cmax es la concentración máxima de fármaco observada
    10) Evaluación del parámetro PK: tmax: tiempo para alcanzar Cmax
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Up to 90 days following the last administration of study treatment (Up to approximately 27 months after first study treatment administration)
    2) Up to 30 days following the last administration of study treatment (Up to approximately 25 months after first study treatment administration)
    3) to 7) Up to 12 months after last patient's first treatment in a given cohort
    8) to 10) Cycle 1, week 1
    1) Hasta 90 días después de la última administración del tratamiento del estudio (Hasta aproximadamente 27 meses después de la administración del primer estudio de tratamiento)
    2) Hasta 30 días después de la última administración del tratamiento del estudio (Hasta aproximadamente 25 meses después de la administración del primer estudio de tratamiento)
    3) a 7) Hasta 12 meses después del primer tratamiento del último paciente en una cohorte dada
    8) a 10) Ciclo 1, semana 1
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Combination with atezolizumab
    Combinación con atezolizumab
    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 trial7
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA29
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Canada
    Czech Republic
    France
    Greece
    Italy
    Netherlands
    Spain
    Taiwan
    United States
    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
    LVLS
    Última visita del último paciente
    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 months
    E.8.9.1In the Member State concerned days24
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial days24
    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: 289
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 96
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 211
    F.4.2.2In the whole clinical trial 385
    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
    Ninguno
    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 Decision2018-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-22
    P. End of Trial
    P.End of Trial StatusOngoing
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