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    Summary
    EudraCT Number:2019-002784-10
    Sponsor's Protocol Code Number:ML41599
    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:2019-10-21
    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 number2019-002784-10
    A.3Full title of the trial
    A PHASE IIIb, SINGLE ARM STUDY OF CARBOPLATIN OR CISPLATIN PLUS ETOPOSIDE WITH ATEZOLIZUMAB (ANTI-PD-L1 ANTIBODY) IN PATIENTS WITH UNTREATED EXTENSIVE-STAGE SMALL CELL LUNG CANCER
    ESTUDIO FASE IIIb, DE UN SOLO BRAZO DE CARBOPLATINO O CISPLATINO MÁS ETOPÓSIDO CON ATEZOLIZUMAB (ANTICUERPO ANTI-PD-L1) EN PACIENTES CON CÁNCER DE PULMÓN MICROCÍTICO EN ETAPA AVANZADA NO TRATADO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study in patients with untreated extensive-stage small cell lung cancer with carboplatin or cisplatin plus etoposide with Atezolizumab
    Estudio para pacientes con cáncer de pulmón microcítico en etapa avanzada no tratado con carboplatino o cisplatino más etopósido con Atezolizumab
    A.4.1Sponsor's protocol code numberML41599
    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 SponsorRoche Farma S.A. (Soc. Unipersonal)
    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 supportRoche Farma S.A. (Soc. Unipersonal)
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRoche Farma S.A. (Soc. Unipersonal)
    B.5.2Functional name of contact pointInmaculada Bermejo
    B.5.3 Address:
    B.5.3.1Street AddressC/Ribera del Lora 50
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28042
    B.5.3.4CountrySpain
    B.5.4Telephone number+34913253700
    B.5.5Fax number------
    B.5.6E-mailspain.start_up_unit@roche.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 Tecentriq.
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Products 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.3.2Product code RO5541267/F03
    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.3.9.2Current sponsor codeRO5541267
    D.3.9.3Other descriptive nameMPDL3280A
    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) Yes
    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
    First-line treatment for extensive-stage small cell lung cancer
    Primera línea de tratamiento en pacientes con Cáncer de pulmón microcítico en etapa avanzada
    E.1.1.1Medical condition in easily understood language
    Untreated extensive-stage small cell lung cancer
    Cáncer de pulmón de célula pequeña en etapa avanzada no tratado
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10041068
    E.1.2Term Small cell lung cancer extensive stage
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10041067
    E.1.2Term Small cell lung cancer
    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
    Main objective is to evaluate the safety of atezolizumab + carboplatin or cisplatin + etoposide
    El objetivo principal de este estudio es evaluar la seguridad de atezolizumab + carboplatino o cisplatino + etopósido
    E.2.2Secondary objectives of the trial
    To evaluate:
    •The efficacy of atezolizumab + carboplatin or cisplatin + etoposide in the intent-to-treat (ITT) population as measured by investigator-assessed progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
    •The efficacy of atezolizumab + carboplatin or cisplatin + etoposide in the ITT population as measured by overall survival (OS)
    •The efficacy of atezolizumab + carboplatin or cisplatin + etoposide in the ITT population as measured by investigator-assessed objective response rate (ORR) according to RECIST v1.1
    •The efficacy of atezolizumab + carboplatin or cisplatin + etoposide in the ITT population as measured by investigator-assessed duration of response (DOR) according to RECIST v1.1
    •The PFS rate at 6 months and at 1 year for the ITT population
    •The OS rate at 6, 12 and 18 months for the ITT population
    • Time to Treatment Discontinuation (TTD)
    Evaluar eficacia de:
    -Atezolizumab + carboplatino o cisplatino + etopósido en la población por intención de tratar (ITT), basándose en la supervivencia libre de progresión (SLP) determinada por el investigador de acuerdo con los Criterios de Evaluación de la Respuesta en Tumores Sólidos, Versión 1.1 (RECIST v1.1)
    -Atezolizumab + carboplatino o cisplatino + etopósido en la población ITT, basándose en la supervivencia global (SG)
    -atezolizumab + carboplatino o cisplatino + etopósido en la población ITT, basándose en la tasa de respuesta objetiva (TRO) determinada por el investigador de acuerdo con los criterios RECIST v1.1
    -Atezolizumab + carboplatino o cisplatino + etopósido en la población ITT, basándose en la duración de la respuesta (DR) determinada por el investigador de acuerdo con los criterios RECIST v1.1
    -Tasa de SLP a 6 meses y 1 año en la población ITT
    -Tasa de SG a 6, 12 y 18 meses en la población ITT
    - Tiempo hasta la suspensión del tratamiento
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Male or female, 18 years of age or older
    •ECOG 0-2
    •Histologically or cytologically confirmed ES-SCLC
    •No prior systemic treatment for ES-SCLC
    •Patients who have received prior chemoradiotherapy for limited-stage SCLC must have been treated with curative intent and experienced a treatment-free interval of at least 6 months since last chemotherapy, radiotherapy, or chemoradiotherapy cycle from diagnosis of extensive-stage SCLC
    •Measurable disease, as defined by RECIST v1.1
    •Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to enrollment
    • A pre-treatment tumor tissue sample must be submitted when available
    •For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 5 months after the last dose of study treatment
    •For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures
    •Ser varón o mujer de ≥ 18 años
    •Estado funcional ECOG de 0-2
    •Presentar CPM-EA confirmado histológica o citológicamente
    •No haber recibido tratamiento sistémico previo para CPM-EA
    •Pacientes que hayan recibido quimiorradioterapia previa para CPM en etapa limitada deben haber sido tratados con intención curativa y haber tenido un intervalo sin tratamiento de al menos 6 meses entre la fecha del diagnóstico de CPM en etapa avanzada y la administración del último ciclo de quimioterapia, radioterapia o quimiorradioterapia
    •Enfermedad medible, definida de acuerdo con los criterios RECIST v1.1
    •Función hematológica y de órganos diana adecuada, definida por los resultados de laboratorio siguientes obtenidos en los 14 días previos a la inclusión en el estudio
    • Se debe enviar una muestra de tejido tumoral previa al tratamiento, cuando esté disponible.
    •Las mujeres potencialmente fértiles deben comprometerse a practicar la abstinencia sexual (es decir, no mantener relaciones heterosexuales) o a usar métodos anticonceptivos que tengan una tasa de fallos anual <1%, durante el período de tratamiento y como mínimo hasta 5 meses después de la administración de la última dosis del tratamiento del estudio
    •Los varones deben comprometerse a practicar la abstinencia sexual (es decir, no mantener relaciones heterosexuales) o a usar métodos anticonceptivos
    E.4Principal exclusion criteria
    •Active or untreated symptomatic CNS metastases which do not fulfill the inclusion criteria as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments
    •Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >=1 week prior to enrollment
    •Leptomeningeal disease
    •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
    •Uncontrolled or symptomatic hypercalcemia
    Patients who are receiving denosumab prior to enrollment must be willing and eligible to discontinue its use and replace it with a bisphosphonate while in the study.
    •Malignancies other than SCLC within 5 years prior to enrollment, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
    Women who are pregnant, lactating, or intending to become pregnant during the study
    •History of autoimmune disease are allowed if controlled and on stable treatment for the last 12 weeks

    •History of idiopathic pulmonary fibrosis, organizing pneumonia drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active
    pneumonitis on screening chest CT scan
    History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
    •Patients with active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen [HBsAg] test result at screening) or hepatitis C virus (HCV)
    •Active tuberculosis
    •Severe infections at the time of enrollment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
    •Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction, or cerebrovascular accident within 3 months prior to enrollment, unstable arrhythmias, or unstable angina
    •Major surgical procedure other than for diagnosis within 28 days prior to enrollment or
    anticipation of need for a major surgical procedure during the course of the study
    •Prior allogeneic bone marrow transplantation or solid organ transplant
    •Any other diseases, metabolic dysfunction, physical examination finding, or clinical
    laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk for treatment complications
    •Patients with illnesses or conditions that interfere with their capacity to understand, follow, and/or comply with study procedures
    •Treatment with any other investigational agent with therapeutic intent within 28 days prior to enrollment
    •Administration of a live, attenuated vaccine within 4 weeks before enrollment or
    anticipation that such a live attenuated vaccine will be required during the study
    •Prior treatment with CD137 agonists or immune checkpoint blockade therapies, anti-PD-1, and anti-PD-L1 therapeutic antibodies
    •Specifically for patients without autoimmune disease: treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to study treatment initiation or anticipated requirement for systemic immunosuppressive medications during the study treatment period
    – For patients with CNS metastases, use of prednisone at a dose (or dose equivalent) of ≤ 20 mg/day is acceptable
    – Chronic use of prednisone or equivalent should be discussed with the Medical Monitor
    – The use of inhaled corticosteroids for chronic obstructive pulmonary disease, mineralocorticoids for patients with orthostatic hypotension, and low-dose supplemental corticosteroids for adrenocortical insufficiency and topical steroids for cutaneous diseases are allowed
    •History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
    •Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
    •History of allergic reactions to carboplatin, cisplatin or etoposide
    •Presencia de metástasis en SNC sintomáticas, activas o no tratadas que no cumplan los criterios de inclusión
    •Compresión de médula espinal no tratada definitivamente con cirugía y/o radioterapia o diagnosticada y tratada previamente, sin evidencia de estabilización clínica de la enfermedad durante >=1 semana, antes de la inclusión en el estudio
    •Enfermedad leptomeníngea
    •Derrame pleural, derrame pericárdico o ascitis no controlados que requieran procedimientos de drenaje repetidos
    •Hipercalcemia no controlada o sintomática:Los pacientes que estén recibiendo denosumab antes de la inclusión deben estar dispuestos y ser capaces de suspender su uso y reemplazarlo por un bifosfonato mientras estén en el estudio.
    •Neoplasias malignas distintas de CPM en los 5 años previos a la inclusión, exceptuando aquellas que tengan un riesgo insignificante de metástasis o muerte y hayan sido tratadas con intención curativa con el resultado esperado
    •Mujeres embarazadas, en período de lactancia o que tengan intención de quedarse embarazadas durante el estudio
    •Está permitida la inclusión de pacientes con antecedentes de enfermedades autoinmunes si están controladas y el tratamiento no se ha modificado en las 12 últimas semanas
    •Antecedentes de fibrosis pulmonar idiopática, neumonía organizada, neumonitis inducida por fármacos, neumonitis idiopática o evidencia de neumonitis activa en el TAC de tórax realizado en el período de selección
    •Pacientes con infección activa por virus de hepatitis B (crónica o aguda, que se define por un resultado positivo en el análisis del antígeno de superficie de la hepatitis B [HBsAg] realizado en el período de selección) o hepatitis C (VHC)
    •Tuberculosis activa
    •Infecciones graves en el momento de la inclusión, incluyendo, aunque no exclusivamente, infecciones complicadas que requieren hospitalización, bacteriemia o neumonía grave
    •Enfermedad cardiovascular significativa, como cardiopatías (de clase II o superior) de la New York Heart Association (NYHA), infarto de miocardio o accidente cerebrovascular en los 3 meses previos a la inclusión, arritmias inestables o angina de pecho inestable
    •Procedimiento de cirugía mayor que no sea con fines diagnósticos en los 28 días previos a la inclusión o que se requiera previsiblemente en el transcurso del estudio
    •Pacientes sometidos previamente a trasplante alogénico de médula ósea o trasplante de órganos sólidos
    •Cualquier otra enfermedad, alteración metabólica, hallazgo en la exploración física o resultado de las pruebas de laboratorio clínico que lleve a sospechar de forma razonable la existencia de una enfermedad o proceso que contraindique el uso de un fármaco en investigación o que pueda afectar a la interpretación de los resultados o que suponga para el paciente un alto riesgo de sufrir complicaciones del tratamiento
    •Pacientes con enfermedades o condiciones que interfieran en su capacidad de entender, seguir y/o cumplir los procedimientos del estudio
    •Tratamiento con cualquier otro agente en investigación con intención terapéutica en los 28 días previos a la inclusión
    •Pacientes que han recibido vacunas vivas atenuadas en las 4 semanas previas a la inclusión o que previsiblemente las requieran durante el estudio
    •Tratamiento previo con agonistas de CD137 o inhibidores de puntos de control inmunitario, anticuerpos terapéuticos anti-PD-1 y anti-PD-L1
    •Específicamente para los pacientes sin enfermedades autoinmunes: Tratamiento con corticosteroides sistémicos u otros inmunosupresores sistémicos en las 2 semanas previas al inicio del tratamiento del estudio o con inmunosupresores sistémicos durante el período de tratamiento del estudio, si es previsible que se requieran
    -En pacientes con metástasis en SNC, es aceptable el uso de prednisona en dosis ≤ 20 mg/día (o una dosis equivalente de un corticosteroide alternativo)
    -uso crónico de prednisona o equivalente debe ser considerado con el monitor médico
    -Permitido uso de corticosteroides inhalados para la enfermedad pulmonar obstructiva crónica, de mineralocorticoides en pacientes con hipotensión ortostática y de dosis bajas de corticosteroides suplementarios para la insuficiencia suprarrenal, así como de esteroides tópicos para enfermedades cutáneas.
    •Antecedentes de reacciones alérgicas graves, anafilácticas u otras reacciones de hipersensibilidad a anticuerpos quiméricos o humanizados o a proteínas de fusión
    •Hipersensibilidad o alergia conocida a biofármacos producidos con células de ovario de hámster chino o a cualquiera de los componentes de la formulación de atezolizumab
    •Antecedentes de reacciones alérgicas a carboplatino, cisplatino o etopósido
    E.5 End points
    E.5.1Primary end point(s)
    1.-Nature, severity, duration, frequency and timing of adverse events (AEs) irrespective of chemotherapy backbone choice
    2.-Changes in vital signs, physical findings, and clinical laboratory results during and following atezolizumab + carboplatin or cisplatin + etoposide administration
    1.-Tipo, severidad, duración, frecuencia y momento de aparición de los acontecimientos adversos (AA), independientemente de la elección del componente básico de la quimioterapia
    2.-Cambios en las constantes vitales, hallazgos de la exploración física y resultados de las pruebas de laboratorio clínico durante y después de la administración de atezolizumab + carboplatino o cisplatino + etopósido
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. and 2.- During all clinical trial
    1 y 2 .- Durante todo el estudio
    E.5.2Secondary end point(s)
    1.- Progression-free survival (PFS)
    2.- Overall survival (OS)
    3.- Objective response rate (ORR)
    4.- Duration of response (DOR)
    5.- PFS rate
    6.- OS rate
    7.- Time to Treatment Discontinuation
    1.- Supervivencia libre de progresión (SLP)
    2.- Supervivencia global (SG)
    3.- Tasa de respuesta objetiva (TRO)
    4.- Duración de la respuesta (DR)
    5.- Tasa de SLP
    6.- Tasa de SG
    7.- Tiempo hasta la suspensión del tratamiento
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.- From screening to progression
    2.- From screening to death
    3.- During all clinical trial
    4.- During all clinical trial
    5.- In 6 month and 1 year visit
    6.-In 6,12 and 18 months visit
    7.- From screening to withdrawal visit
    1.- Desde screening a progresión
    2.- De screening a fallecimiento
    3.- Durante todo el estudio
    4.- Durante todo el estudio
    5.- En la visita de 6 meses y 1 año
    6.- En las visitas de 6, 12 y 18 meses
    7.- Desde la visita de screening a la de discontinuación
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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 No
    E.8.1.1Randomised No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned4
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    The end of study will occur when all patients enrolled have either died, withdrawn consent, are lost to follow up, or have been followed for 24 months since the last study patient is enrolled, whichever occurs first.

    Additionally, the Sponsor may decide to terminate the study at any time.
    El estudio terminará cuando todos los pacientes incluidos hayan fallecido, retirado su consentimiento, se haya perdido su seguimiento o hayan estado en seguimiento durante 24 meses desde la inclusión del último paciente del estudio, lo que ocurra primero.

    Además, el estudio puede terminar en cualquier momento por decisión del promotor
    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
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state150
    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)
    na
    na
    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 Decision2019-10-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-13
    P. End of Trial
    P.End of Trial StatusCompleted
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