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    Summary
    EudraCT Number:2019-001800-39
    Sponsor's Protocol Code Number:D3251C00014
    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:2019-10-21
    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 number2019-001800-39
    A.3Full title of the trial
    A Multicenter, Randomized, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab 100 mg in Patients with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) with a History of Frequent COPD Exacerbations and Elevated Peripheral Blood Eosinophils (RESOLUTE)
    Ensayo de fase III, multicéntrico, aleatorizado, doble ciego, de administración crónica, con grupos paralelos y controlado con placebo para evaluar la eficacia y la seguridad de benralizumab 100 mg en pacientes con enfermedad pulmonar obstructiva crónica (EPOC) de moderada a muy grave y con antecedentes de exacerbaciones frecuentes de la EPOC y eosinófilos elevados en sangre periférica (RESOLUTE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of Benralizumab in Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) with a History of Frequent Exacerbations
    Eficacia y seguridad de benralizumab en la enfermedad pulmonar obstructiva crónica (EPOC) de moderada a muy grave con antecedentes de exacerbaciones frecuentes
    A.3.2Name or abbreviated title of the trial where available
    RESOLUTE
    RESOLUTE
    A.4.1Sponsor's protocol code numberD3251C00014
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZenecaAB
    B.5.2Functional name of contact pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressN/A
    B.5.3.2Town/ cityN/A
    B.5.3.3Post codeN/A
    B.5.3.4CountrySweden
    B.5.4Telephone number+1 87 72409 479
    B.5.6E-mailinformation.center@astrazeneca.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 nameBenralizumab
    D.3.2Product code Medi-563
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBenralizumab
    D.3.9.1CAS number 1044511-01-4
    D.3.9.2Current sponsor codeMEDI-563
    D.3.9.3Other descriptive nameBenralizumab
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Obstructive Pulmonary Disease
    Enfermedad pulmonar obstructiva crónica
    E.1.1.1Medical condition in easily understood language
    COPD
    EPOC
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10009033
    E.1.2Term Chronic obstructive pulmonary disease
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of benralizumab on COPD exacerbations in patients with moderate to very severe COPD
    Evaluar el efecto de benralizumab sobre las exacerbaciones de la EPOC en pacientes con EPOC de moderada a muy grave.
    E.2.2Secondary objectives of the trial
    - To evaluate the effect of benralizumab on severe COPD exacerbations (leading to hospitalization or death)
    - To evaluate the effect of benralizumab on COPD exacerbations involving emergency room visits and hospitalizations
    - To evaluate the effect of benralizumab on other parameters associated with COPD exacerbations
    - To evaluate the effect of benralizumab on health status/health-related quality of life
    - To evaluate the effect of benralizumab on respiratory symptoms
    - To evaluate the effect of benralizumab on pulmonary function
    - To evaluate the effect of benralizumab on all cause and respiratory-related mortality
    - To evaluate the effect of benralizumab on health care resource utilization due to COPD
    - To evaluate the pharmacokinetics and immunogenicity of benralizumab in this patient population
    - Evaluar el efecto de benralizumab sobre las exacerbaciones graves de la EPOC (que motivan la hospitalización o la muerte).
    - Evaluar el efecto de benralizumab sobre las exacerbaciones de la EPOC que motivan visitas a servicios de urgencias y hospitalizaciones.
    - Evaluar el efecto de benralizumab sobre otros parámetros asociados a las exacerbaciones de la EPOC.
    - Evaluar el efecto de benralizumab sobre el estado de salud y la calidad de vida relacionada con la salud.
    - Evaluar el efecto de benralizumab sobre los síntomas respiratorios.
    - Evaluar el efecto de benralizumab sobre la función respiratoria.
    - Evaluar el efecto de benralizumab sobre la mortalidad global y de origen respiratorio.
    - Evaluar el efecto de benralizumab 100 mg sobre la utilización de recursos sanitarios por EPOC.
    - Evaluar la farmacocinética y la inmunogenicidad de benralizumab en esta población de pacientes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1 Provision of informed consent

    2 Age 40 to 85 years

    3 Male and/or female.

    4 Current or former smoker with a tobacco history of ≥10 pack-years.

    5 History of moderate to very severe COPD with a post-bronchodilator FEV1/FVC<0.70 and FEV1 ≤65% of predicted normal value.

    6 Documented history of 2 or more COPD exacerbations that required treatment with systemic corticosteroids and/or hospitalization within 52 weeks prior to enrollment.
    (a) Exacerbations treated with antibiotics alone are excluded unless accompanied by treatment with systemic corticosteroids and/or hospitalization.
    (b) Hospitalization is defined as an inpatient admission ≥24 hours
    (c) Previous exacerbations should be confirmed to have occurred while on stable triple therapy for COPD.

    7 Documented use of triple (ICS/LABA/LAMA) background therapy for COPD throughout the year (52 weeks) prior to enrollment.
    (a) ICS dose should be equivalent to ≥500 mcg of fluticasone propionate daily.
    (b) Total cumulative duration of not being on triple background therapy must not exceed 2 months.
    (c) Stable therapy/doses for the last 3 months prior to randomization.

    8 Blood eosinophil count ≥300/μL at screening and documented historical eosinophil count of ≥150/μL within 52 weeks of enrollment (or repeated testing during run-in).

    9 CAT total score ≥15 at Visit 1.

    10 Negative pregnancy test for females of childbearing potential (WOCBP) at Visit 1.

    11 Women of childbearing potential (WOCBP) must agree to use a highly effective method of birth control from randomization throughout the study and 16 weeks after last dose of IP.

    Women not of childbearing potential are defined as women who are either permanently sterilized or postmenopausal (confirmed by FSH test for women <50 years).
    1 Firma del consentimiento informado
    2 40 a 85 años de edad
    3 Varones o mujeres.
    4 Fumador activo o exfumador con antecedentes de tabaquismo ≥ 10 paquetes-año.
    5 Antecedentes de EPOC moderada a muy grave con un FEV1/FVC < 0,70 después de administrar un broncodilatador y un FEV1 ≤ 65% del valor normal teórico.
    6 Antecedentes documentados de dos o más exacerbaciones de la EPOC que precisaran tratamiento con corticosteroides sistémicos u hospitalización en las 52 semanas previas a la inclusión.
    (a) Se excluyen las exacerbaciones tratadas con antibióticos solos, a menos que se acompañasen de tratamiento con corticosteroides sistémicos u hospitalización.
    (b) La hospitalización se define como un ingreso en el hospital ≥ 24 horas
    (c) Se debe confirmar que se han producido exacerbaciones previas durante el tratamiento triple estable para la EPOC.
    7 Uso documentado de tratamiento de base triple (CI/ABAP/AMAP) para la EPOC durante todo el año (52 semanas) antes de la inclusión.
    (a) La dosis de CI debe ser equivalente a ≥ 500 µg de propionato de fluticasona al día.
    (b) El periodo total acumulado sin tratamiento de base triple no debe superar los 2 meses.
    (c) Tratamiento/dosis estables en los 3 meses previos a la aleatorización.
    8 Recuento de eosinófilos en sangre ≥ 300/μl en la selección y recuento histórico documentado de eosinófilos ≥ 150/μl en las 52 semanas previas a la inclusión (o repetición del análisis durante la preinclusión).
    9 Puntuación total de la CAT ≥ 15 en la visita 1.
    10 Prueba de embarazo negativa en las mujeres en edad fértil (MEF) en la visita 1.
    11 Las mujeres en edad fértil (MEF) deben comprometerse a utilizar un método anticonceptivo muy eficaz desde la aleatorización y durante todo el estudio hasta 16 semanas después de la última dosis del PEI.
    Las mujeres que no están en edad fértil se definen como aquellas que están esterilizadas de manera permanente o son posmenopáusicas (confirmado mediante un análisis de la FSH en las mujeres menores de 50 años).
    E.4Principal exclusion criteria
    1 Clinically important pulmonary disease other than COPD
    2 Current diagnosis of asthma, prior history of asthma or asthma-COPD overlap
    3 Radiological findings of a respiratory disease other than COPD contributing to respiratory symptoms. Solitary pulmonary nodules without appropriate follow up or findings of acute infection.
    4 Another pulmonary or systemic disease associated with elevated peripheral eosinophil counts.
    5 Any unstable disorder that could affect patient safety, study findings or the patient’s ability to complete the study.
    6 Any clinically significant abnormal findings in physical examination, vital signs, ECG, laboratory tests could affect patient safety, study findings or the patient’s ability to complete the study.
    7 Cor pulmonale and/or right ventricular failure.
    8 Long-term treatment with oxygen >4.0 L/min and/or oxyhemoglobin saturation <89% while breathing supplemental oxygen.
    9 Use of any non-invasive positive pressure ventilation device (NIPPV). Note: use of CPAP or BiPAP for Sleep Apnea Syndrome is allowed.
    10 Known immunodeficiency disorder, including positive HIV-1/2 testing.
    11 Active liver disease. Chronic stable hepatitis B and C (including positive HBsAg or hepatitis C antibody testing), or other stable chronic liver disease are acceptable.
    12 ALT or AST ≥3 times the upper limit of normal, confirmed by repeated testing during the run-in period.
    13 Helminth parasitic infection within 24 weeks prior to enrollment, not treated or failed to respond to standard of care therapy.
    14 Alcohol or drug abuse within the past year, which may compromise the study data.
    15 Malignancy, current or within the past 5 years, except for adequately treated non invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma-in-situ treated with apparent success more than 1 year prior to Visit 1. Suspected malignancy or undefined neoplasms.
    16 Evidence of active tuberculosis, as judged by investigator. Patients with a recent (within 2 years) first-time or newly positive PPD or Quantiferon test need to complete an appropriate course of treatment before enrollment. Evaluation will be according to the local standard of care.
    17 Participation, or planned participation, in intensive COPD rehabilitation program (maintenance phase of a rehabilitation is allowed).
    18 History of surgical or endoscopic lung volume reduction within the 6 months prior to enrollment. History of partial or total lung resection (single lobe or segmentectomy is acceptable).
    19 Scheduled major surgical procedure during the study. Minor elective procedures are allowed.
    20 History of anaphylaxis to benralizumab or any other biologic therapy.
    21 Receipt of blood products or immunoglobulins within 30 days prior to randomization.
    22 Receipt of any marketed or investigational biologic product within 4 months or 5 half-lives prior to randomization, whichever is longer.
    23 Receipt of live attenuated vaccines 30 days prior to randomization.
    24 Chronic use of immunosuppressive medication or expected need for chronic use during the study.
    25 Chronic use of antibiotics if duration of treatment is <9 months prior to randomization. Chronic macrolide or other antibiotic therapy is allowed provided the patient has been on stable dose/regimen for ≥9 months prior to randomization and has had ≥2 COPD exacerbations while on stable therapy.
    26 Receipt of any investigational non-biologic product within 30 days or 5 half-lives prior to enrollment.
    27 Receipt of benralizumab within 12 months prior to enrollment.
    28 Known history of allergy or reaction to any component of the IP formulation.
    1 Enfermedad pulmonar clínicamente importante distinta de la EPOC.
    2 Diagnóstico actual de asma, antecedentes de asma o superposición asma-EPOC
    3 Hallazgos radiológicos de una enfermedad respiratoria distinta de la EPOC que contribuyen a los síntomas respiratorios. Nódulos pulmonares solitarios sin seguimiento adecuado ni signos de infección aguda.
    4 Otra enfermedad pulmonar o general acompañada de recuentos elevados de eosinófilos periféricos.
    5 Cualquier trastorno inestable que pueda afectar a la seguridad del paciente, a los resultados del estudio o a la capacidad del paciente para completar el estudio.
    6 Cualquier hallazgo anormal clínicamente significativo en la exploración física, las constantes vitales, el ECG o las pruebas analíticas que podría afectar a la seguridad del paciente, a los resultados del estudio o a la capacidad del paciente para completar el estudio.
    7 Cardiopatía pulmonar o insuficiencia ventricular derecha.
    8 Tratamiento a largo plazo con oxígeno > 4,0 l/min o saturación de oxihemoglobina < 89% mientras se respira oxígeno suplementario.
    9 Uso de cualquier dispositivo no invasivo de ventilación con presión positiva (VNIPP). Nota: Se permite el uso de CPAP o BiPAP para el síndrome de apnea del sueño.
    10 Trastorno de inmunodeficiencia confirmado, incluido un análisis positivo del VIH-1/2.
    11 Hepatopatía activa. Son aceptables la hepatitis B y C crónica estable (incluido un resultado positivo en el análisis de HBsAg o de anticuerpos contra la hepatitis C) u otra hepatopatía crónica estable.
    12 ALT o AST ≥ 3 veces el límite superior de la normalidad, confirmado mediante análisis repetidos durante el período de preinclusión.
    13 Infección parasitaria por helmintos en las 24 semanas previas a la inclusión, no tratada o que no responde al tratamiento habitual.
    14 Abuso de alcohol o drogas en el último año que pueda afectar a los datos del estudio.
    15 Tumor maligno actual o en los 5 últimos años, excepto carcinoma basocelular y espinocelular no invasor de la piel debidamente tratado y carcinoma de cuello uterino in situ tratado con éxito aparente más de 1 año antes de la visita 1. Sospecha de neoplasia maligna o neoplasias no definidas.
    16 Signos de tuberculosis activa, según el criterio del investigador.
    Los pacientes con una prueba PPD o Quantiferon positiva reciente (en los 2 años anteriores) por primera vez o en una fecha reciente deberán completar un ciclo adecuado de tratamiento antes de la inclusión. La evaluación se realizará conforme a las normas asistenciales locales.
    17 Participación, o participación prevista, en un programa de rehabilitación intensiva de la EPOC (se permite la fase de mantenimiento de una rehabilitación).
    18 Antecedentes de reducción del volumen pulmonar quirúrgico o endoscópico en los 6 meses previos a la inclusión. Antecedentes de resección pulmonar parcial o total (se acepta una segmentectomía o un único lóbulo).
    19 Intervención de cirugía mayor programada durante el estudio. Se permiten procedimientos programados de cirugía menor.
    20 Antecedentes de anafilaxia a benralizumab o cualquier otro tratamiento biológico.
    21 Recepción de hemoderivados o inmunoglobulinas en los 30 días previos a la aleatorización.
    22 Recepción de cualquier producto biológico comercializado o en investigación en los 4 meses o 5 semividas previos a la aleatorización, lo que suponga más tiempo.
    23 Recepción de vacunas de microorganismos vivos atenuados 30 días antes de la aleatorización.
    24 Uso crónico de medicación inmunosupresora o necesidad prevista de uso crónico durante el estudio.
    25 Uso crónico de antibióticos si la duración del tratamiento es < 9 meses antes de la aleatorización. Se permite el tratamiento crónico con macrólidos u otros antibióticos siempre que el paciente haya recibido una dosis/pauta estable durante ≥ 9 meses antes de la aleatorización y haya tenido ≥ 2 exacerbaciones de la EPOC durante el tratamiento estable.
    26 Recepción de cualquier producto no biológico en investigación en los 30 días o 5 semividas previos a la inclusión.
    27 Recepción de benralizumab en los 12 meses previos a la inclusión.
    28 Antecedentes conocidos de alergia o reacción a cualquiera de los componentes de la formulación del PEI.
    E.5 End points
    E.5.1Primary end point(s)
    Annualized rate of moderate or severe COPD exacerbations, where a COPD exacerbation is defined by symptomatic worsening of COPD requiring:

    • Use of systemic corticosteroids for at least 3 days; a single depot injectable dose of
    corticosteroids will be considered equivalent to a 3-day course of systemic corticosteroids; and/or

    • Use of antibiotics; and/or

    • An inpatient hospitalization or death due to COPD
    Tasa anualizada de exacerbaciones graves de la EPOCa, definiéndose una exacerbación grave como un empeoramiento sintomático de la EPOC que motiva:

    • Uso de corticoides sistémicos durante al menos tres días; la administración de una única dosis inyectable de liberación prolongada de corticoides equivalente a un ciclo de tres días de corticoides sistémicos, y/o
    • Uso de antibióticos; y/u
    • Hospitalización o muerte por EPOC.
    E.5.1.1Timepoint(s) of evaluation of this end point
    over first 56 weeks
    durante las primeras 56 semanas
    E.5.2Secondary end point(s)
    1. Annualized rate of severe COPD exacerbations, where a severe COPD exacerbation is defined by symptomatic worsening of COPD requiring an inpatient hospitalization or results in death due to COPD

    2. Annualized rate of COPD exacerbations that are associated with an emergency room/emergency department visit or a hospitalization due to COPD


    3. Time to first COPD exacerbation

    4. • SGRQ total and domain scores
    • CAT total score

    5. E-RS:COPD total and domain scores

    6. Change from baseline in pre-dose/pre-bronchodilator FEV1 at the study site

    7. Mortality rate

    8. Annual rate of hospitalizations due to COPD; Length of hospital stay; ICU days; annual rate of hospitalizations and emergency department visits combined due to COPD; annual rate of unscheduled outpatient visits including unscheduled visits to study sites due to COPD; and annual rate of unscheduled healthcare encounters due to COPD

    9. • Serum benralizumab concentration
    • Anti-benralizumab antibodies
    1. Tasa anualizada de exacerbaciones graves de la EPOC, definiéndose una exacerbación grave como un empeoramiento sintomático de la EPOC que motiva la hospitalización o la muerte por EPOC

    2. Tasa anualizada de exacerbaciones de la EPOC asociadas a una visita a un servicio de urgencias o una hospitalización por EPOC.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Over 56 weeks or through End of Treatment
    Durante 56 semanas o hasta el final del 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 No
    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 No
    E.6.11Pharmacogenomic Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    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 EEA86
    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
    Argentina
    Austria
    Brazil
    Canada
    Chile
    Colombia
    Czech Republic
    Denmark
    Germany
    Hungary
    Italy
    Japan
    Korea, Democratic People's Republic of
    Mexico
    Philippines
    Poland
    Spain
    Sweden
    Turkey
    United Kingdom
    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
    The end of study is defined as the last expected visit/contact of the last patient undergoing the study.
    El fin de estudio se define como la última visita del último paciente/contacto del último paciente del estudio.
    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 months10
    E.8.9.1In the Member State concerned days6
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days28
    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: 434
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 434
    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 state21
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 266
    F.4.2.2In the whole clinical trial 868
    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 Decision2019-12-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-05
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
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