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    Summary
    EudraCT Number:2018-000312-24
    Sponsor's Protocol Code Number:BGB-A317-305
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-01-14
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2018-000312-24
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Clinical Study Comparing the Efficacy and Safety of Tislelizumab (BGB-A317) plus Platinum and Fluoropyrimidine Versus Placebo plus Platinum and Fluoropyrimidine as First-Line Treatment in Patients with Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma.
    Estudio clínico en fase III aleatorizado, doble ciego, controlado con placebo, para comparar la eficacia y la seguridad de tislelizumab (BGB-A317) más platino y fluoropirimidina frente a placebo más platino y fluoropirimidina como tratamiento de primera línea en pacientes con adenocarcinoma gástrico o de la unión gastroesofágica localmente avanzado irresecable o metastásico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomised, Double blind, Placebo controlled Phase 3 study comparing Efficacy and Safety of Tislelizumab plus Chemotherapy versus Placebo plus Chemotherapy in patients with Gastric Cancer
    Estudio clínico en fase III aleatorizado, doble ciego, controlado con placebo, para comparar la eficacia y la seguridad de tislelizumab más quimioterapia frente a placebo más quimioterapia en pacientes con cáncer de estómago
    A.4.1Sponsor's protocol code numberBGB-A317-305
    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 SponsorBeiGene, Ltd
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBeiGene Ltd
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBeiGene Ltd
    B.5.2Functional name of contact pointBeiGene Clinical Support
    B.5.3 Address:
    B.5.3.1Street Addressc/o BeiGene USA Inc., 1900 Powell Street, Suite 500
    B.5.3.2Town/ cityEmeryville
    B.5.3.3Post code94608
    B.5.3.4CountryUnited States
    B.5.4Telephone number+34934894301
    B.5.6E-mailBeiGeneClinicalSupportUS@beigene.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 nameTislelizumab
    D.3.2Product code BGB-A317
    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 INNtislelizumab
    D.3.9.1CAS number 1858168-59-8
    D.3.9.2Current sponsor codeBGB-A317
    D.3.9.3Other descriptive nameBGB-A317
    D.3.9.4EV Substance CodeSUB189550
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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 Yes
    D.3.11.13.1Other medicinal product typemonoclonal antibody
    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 placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
    Adenocarcinoma gástrico o de la unión gastroesofágica localmente avanzado irresecable o metastásico
    E.1.1.1Medical condition in easily understood language
    Gastric Cancer
    Cancer Gástrico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001158
    E.1.2Term Adenocarcinoma gastric stage IV with metastases
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To compare progression-free survival per Response Evaluation Criteria in Solid Tumors 1.1 of tislelizumab plus chemotherapy
    versus placebo plus chemotherapy in the intent-to-treat and programmed cell death protein ligand-1 (PD-L1) positive analysis sets
    • To compare overall survival of tislelizumab plus chemotherapy versus placebo plus chemotherapy in the intent-to-treat and programmed cell death protein ligand-1 positive analysis sets
    Comparar la supervivencia sin progresión según los Criterios de evaluación de la respuesta en tumores sólidos 1.1, según lo evaluado por el comité de revisión independiente enmascarado (CRIE) de tislelizumab más quimioterapia frente a placebo más quimioterapia en los grupos de análisis por intención de tratar y positivos para el ligando 1 de la proteína de muerte celular programada (PD-L1)
    • Comparar la supervivencia general de tislelizumab más quimioterapia frente a placebo más quimioterapia en los grupos de análisis por intención de tratar y positivos para el ligando 1 de la proteína de muerte celular programada
    E.2.2Secondary objectives of the trial
    • To evaluate overall response rate, and duration of response, per Response Evaluation Criteria in Solid Tumors 1.1.
    • To evaluate European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Gastric Cancer Score, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 Score and European Quality of Life 5-Dimensions 5-Levels Health Questionnaire Score
    • To evaluate the safety and tolerability profile of tislelizumab or placebo plus chemotherapy
    • Evaluar la tasa de respuesta global y la duración de la respuesta, conforme a los Criterios de evaluación de la respuesta en tumores sólidos 1.1, según lo evaluado por el comité de revisión independiente enmascarado
    • Evaluar la puntuación del módulo de cáncer gástrico del cuestionario de calidad de vida QLQ-STO22 de la Organización Europea para la Investigación y el Tratamiento del Cáncer, la puntuación del cuestionario general de calidad de vida de 30 ítems de la Organización Europea para la Investigación y el Tratamiento del Cáncer y la puntuación del cuestionario sanitario europeo de calidad de vida de 5 dimensiones y 5 niveles
    • Evaluar el perfil de seguridad y tolerabilidad de tislelizumab o placebo más quimioterapia
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Able to provide written informed consent and can understand and comply with the requirements of the study
    2. Adult patients (≥18 years of age or acceptable age according to local regulations, whichever is older) at the time of voluntarily signing informed consent.
    3. Locally advanced unresectable or metastatic GC or GEJ carcinoma and have histologically confirmed adenocarcinoma
    4. At least 1 measurable lesion as defined per RECIST v1.1 as determined by investigator assessment.
    5. No previous systemic therapy for locally advanced unresectable or metastatic gastric/GEJ cancer. Note: Patients may have received prior neoadjuvant or adjuvant therapy as long as it was completed and have no recurrence or disease progression for at least 6 months.
    6. Patients must be able to provide tumor tissues.
    7. ECOG PS ≤ 1 within 7 days prior to randomization
    8. Adequate organ function:
    a. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, hemoglobin ≥ 90 g/L. Note: Patients must not have required a blood transfusion or growth factor support ≤ 14 days before sample collection
    b. Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or estimated Glomerular Filtration Rate ≥ 60 mL/min/1.73 m2. (Appendix 8)
    c. Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
    d. Serum total bilirubin ≤ 1.5 x ULN (total bilirubin must be < 3 x ULN for patients with Gilberts syndrome)
    e. International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 x ULN unless patient is receiving anticoagulant therapy and PT values are within the intended therapeutic range of the anticoagulant
    f. Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN
    g. Albumin ≥ 3.0 g/dL or 30 g/liter
    9. Females of childbearing potential must have a negative urine or serum pregnancy test within 7 days of randomization and must be willing to use a highly effective method of birth control.
    10. Non-sterile males must be willing to use a highly effective method of birth control.
    1. Capaz de proporcionar un consentimiento informado por escrito y puede comprender y cumplir con los requisitos del estudio
    2. Pacientes adultos (≥18 años de edad o edad aceptable de acuerdo con las regulaciones locales, la que sea mayor) al momento de firmar voluntariamente el consentimiento informado.
    3. Carcinoma GC o GEJ localmente no resecable o metastático avanzado y adenocarcinoma histológicamente confirmado
    4. Al menos 1 lesión medible según lo definido por RECIST v1.1 según lo determinado por la evaluación del investigador.
    5. No hay terapia sistémica previa para el cáncer gástrico / GEJ localmente no resecable o metastásico. Nota: los pacientes pueden haber recibido tratamiento neoadyuvante o adyuvante previo, siempre y cuando se haya completado y no tengan recurrencia o progresión de la enfermedad durante al menos 6 meses.
    6. Los pacientes deben poder proporcionar tejidos tumorales.
    7. ECOG PS ≤ 1 dentro de los 7 días anteriores a la aleatorización
    8. Función de órgano adecuada:
    a. Recuento absoluto de neutrófilos (ANC) ≥ 1.5 x 109 / L, plaquetas ≥ 100 x 109 / L, hemoglobina ≥ 90 g / L. Nota: los pacientes no deben haber requerido una transfusión de sangre o un apoyo del factor de crecimiento ≤ 14 días antes de la recolección de la muestra
    segundo. Creatinina sérica ≤ 1.5 x límite superior normal (ULN) o tasa de filtración glomerular estimada ≥ 60 ml / min / 1.73 m2. (Apéndice 8)
    do. Aspartato transaminasa (AST) y alanina aminotransferasa (ALT) ≤ 2.5 x ULN
    re. Bilirrubina total en suero ≤ 1.5 x ULN (la bilirrubina total debe ser <3 x ULN para pacientes con síndrome de Gilberts)
    mi. Relación internacional normalizada (INR) o tiempo de protrombina (PT) ≤ 1.5 x ULN, a menos que el paciente esté recibiendo terapia anticoagulante y los valores de PT estén dentro del rango terapéutico previsto del anticoagulante
    F. Tiempo de tromboplastina parcial activada (aPTT) ≤ 1.5 x ULN
    sol. Albúmina ≥ 3.0 g / dL o 30 g / litro
    9. Las mujeres en edad fértil deben tener una prueba de embarazo negativa en orina o suero dentro de los 7 días de la aleatorización y deben estar dispuestas a usar un método anticonceptivo altamente eficaz.
    10. Los hombres no estériles deben estar dispuestos a usar un método anticonceptivo altamente efectivo.
    E.4Principal exclusion criteria
    1. Patient has squamous cell or undifferentiated or other histological type GC
    2. Active leptomeningeal disease or uncontrolled brain metastasis.
    3. Active autoimmune diseases or history of autoimmune diseases that may relapse.
    4. Any active malignancy ≤ 2 years before randomization, with the exception of the specific cancer under investigation in this study and any locally recurring cancer that has been treated curatively.
    5. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage within 7 days prior to randomization (The cytological confirmation of any effusion is permitted).
    6. Have clinically significant bleeding from the gastrointestinal (GI) tract within 3 months prior to randomization
    7. Have a history of GI perforation and/or fistulae within 6 months prior to randomization
    8. Have a clinically significant bowel obstruction
    9. Diagnosed with gastric or GEJ adenocarcinoma with positive HER2
    10. Any condition that requires systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before randomization
    11. With history of interstitial lung disease, non-infectious pneumonitis or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung diseases, etc.
    12. With severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection, etc.
    13. A known history of HIV infection
    14. Patients with cardiovascular risk factors.
    15. Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2 or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
    1. El paciente tiene células escamosas o indiferenciadas u otro tipo histológico GC
    2. Enfermedad leptomeníngea activa o metástasis cerebral descontrolada.
    3. Enfermedades autoinmunes activas o antecedentes de enfermedades autoinmunes que pueden recaer.
    4. Cualquier malignidad activa ≤ 2 años antes de la aleatorización, con la excepción del cáncer específico que se está investigando en este estudio y cualquier cáncer localmente recurrente que haya sido tratado de forma curativa.
    5. Derrame pleural incontrolable, derrame pericárdico o ascitis que requiera drenaje frecuente dentro de los 7 días previos a la aleatorización (se permite la confirmación citológica de cualquier derrame).
    6. Tiene sangrado clínicamente significativo del tracto gastrointestinal (GI) dentro de los 3 meses anteriores a la aleatorización
    7. Tener un historial de perforación GI y / o fístulas dentro de los 6 meses anteriores a la aleatorización
    8. Tener una obstrucción intestinal clínicamente significativa.
    9. Diagnosticado con adenocarcinoma gástrico o GEJ con HER2 positivo.
    10. Cualquier condición que requiera tratamiento sistémico con corticosteroides (> 10 mg diarios de prednisona o equivalente) u otro medicamento inmunosupresor ≤ 14 días antes de la aleatorización
    11. Con antecedentes de enfermedad pulmonar intersticial, neumonitis no infecciosa o enfermedades sistémicas no controladas, incluyendo diabetes, hipertensión, fibrosis pulmonar, enfermedades pulmonares agudas, etc.
    12. Con infecciones crónicas o activas graves que requieran terapia sistémica antibacteriana, antifúngica o antiviral, incluida la infección por tuberculosis, etc.
    13. Una historia conocida de infección por VIH
    14. Pacientes con factores de riesgo cardiovascular.
    15. Terapia previa con un anti-PD-1, anti-PD-L1, anti-PD-L2 o cualquier otro anticuerpo o medicamento dirigido específicamente a la coestimulación de las células T o vías de control.
    E.5 End points
    E.5.1Primary end point(s)
    • Progression-free survival
    • Overall survival
    •Supervivencia sin progresión
    •Supervivencia General
    E.5.1.1Timepoint(s) of evaluation of this end point
    • Progression-free survival– defined as the time from the date of randomization to the date of the first objectively documented tumor progression, assessed per Response Evaluation Criteria in Solid Tumors v1.1, or death, whichever occurs first.
    • Overall survival – defined as the time from the date of randomization to the date of death due to any cause
    •Supervivencia sin progresión - definida como el tiempo transcurrido desde la aleatorización hasta la progresión de la enfermedad objetiva, evaluado según los criterios de evaluación de respuesta en tumores sólidos (RECIST) v1.1, o la muerte por cualquier causa, lo que ocurra primero
    • Supervivencia General- se define como el tiempo desde la fecha de la asignación al azar hasta la fecha de la muerte por cualquier causa
    E.5.2Secondary end point(s)
    • Overall response rate.
    • Duration of response (DOR) – defined as the time from the first determination of an objective response per Response Evaluation Criteria in Solid Tumors v1.1, until the first documentation of progression or death, whichever occurs first
    • Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Gastric Cancer Module QLQ-STO22 Score and change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 and European Quality of Life 5-Dimensions 5-Levels Health Questionnaire Score
    • The incidence and severity of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0
    •Tasa de respuesta global
    •Duración de la respuesta evaluada por el comité de revisión independiente enmascarado, definida como el tiempo transcurrido desde la primera determinación de una respuesta objetiva según los Criterios de evaluación de la respuesta en tumores sólidos v1.1, hasta la primera documentación de progresión o muerte, lo que ocurra primero
    •Cambio desde el inicio en la puntuación del módulo de cáncer gástrico del cuestionario de calidad de vida QLQ-STO22 de la Organización Europea para la Investigación y el Tratamiento del Cáncer, y cambio desde el inicio en la puntuación del cuestionario general de calidad de vida de 30 ítems de la Organización Europea para la Investigación y el Tratamiento del Cáncer y en la puntuación del cuestionario sanitario europeo de calidad de vida de 5 dimensiones y 5 niveles.
    •La incidencia e intensidad de los acontecimientos adversos de acuerdo con los Criterios terminológicos comunes para acontecimientos adversos del Instituto Nacional del Cáncer v5.0
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Overall response rate: Defined as the proportion of patients whose best overall response is complete response or partial response per Response Evaluation Criteria in Solid Tumors v1.1
    • Duration of response – defined as the time from the first determination of an objective response per Response Evaluation Criteria in Solid Tumors v1.1, until the first documentation of progression or death, whichever occurs first
    • Tasa de respuesta general: definida como la proporción de pacientes cuya mejor respuesta general es la respuesta completa o la respuesta parcial según los criterios de evaluación de la respuesta en tumores sólidos v1.1
    • Duración de la respuesta: definida como el tiempo desde la primera determinación de una respuesta objetiva según los Criterios RECIST v1.1, hasta la primera documentación de progresión o muerte, lo que ocurra primero
    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 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 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    China
    Germany
    Italy
    Japan
    Korea, Republic of
    Poland
    Romania
    Russian Federation
    Spain
    Taiwan
    Turkey
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The study will continue until the last patient has died, becomes lost to follow up, or withdraws from study, or until sponsor decides to terminate the study.
    El estudio continuará hasta que el último paciente fallezca, se pierda durante el seguimiento o se retire del estudio, o hasta que el patrocinador decida interrumpir el estudio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months43
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months43
    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: 440
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 280
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 182
    F.4.2.2In the whole clinical trial 720
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-03-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-29
    P. End of Trial
    P.End of Trial StatusOngoing
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