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    Summary
    EudraCT Number:2016-001643-39
    Sponsor's Protocol Code Number:2215-CL-0302
    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:2016-11-15
    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 number2016-001643-39
    A.3Full title of the trial
    A Phase 3 Multicenter, Randomized, Double-Blind, Placebo- Controlled Trial of the FLT3 Inhibitor Gilteritinib (ASP2215) Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects with FLT3/ITD AML in First Complete Remission
    Ensayo clínico de Fase 3, multicéntrico, aleatorizado, en doble ciego y controlado con placebo, de gilteritinib (ASP2215), un inhibidor de FLT3, administrado como tratamiento de mantenimiento tras el tratamiento de inducción/consolidación en sujetos con leucemia mieloide aguda con FLT3/ITD en primera remisión completa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effectiveness and safety of gilteritinib (ASP2215) as maintenance treatment (maintain the response achieved during the first course of treatment) for Acute myeloid leukemia patients who are in a first complete remission (no residual leukemia cells in your bone marrow), with mutations in the FLT3 gene compared to placebo given alone.
    Efectividad y seguridad de gilteritinib (ASP2215) administrado como medicamento único en comparación con placebo como tratamiento de mantenimiento (mantener la respuesta alcanzada durante el primer ciclo de tratamiento) en pacientes con leucemia mieloide aguda que están en primera remission complete (sin células residuales en tu medula ósea) con mutaciones en el gen FLT3.
    A.4.1Sponsor's protocol code number2215-CL-0302
    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 SponsorAstellas Pharma Global Development, Inc. (APGD)
    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 supportAstellas Pharma Global Development, Inc. (APGD)
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstellas Pharma Europe B.V.
    B.5.2Functional name of contact pointService Desk - Global Clinical Dev.
    B.5.3 Address:
    B.5.3.1Street AddressSylviusweg 62
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 BE
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31715455878
    B.5.5Fax number+31715455224
    B.5.6E-mailcontact@nl.astellas.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 nameGilteritinib
    D.3.2Product code ASP2215
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGILTERITINIB
    D.3.9.2Current sponsor codeASP2215
    D.3.9.4EV Substance CodeSUB177203
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Subjects diagnosed with FLT3/ITD acute myeloid leukemia (AML) in CR1, including CRp and CRi, for whom a decision not to proceed with transplantation has been made, or a suitable donor could not be identified.
    Sujetos diagnosticados con leucemia mieloide aguda con FLT3/ITD en primera remisión completa (CR1) (que incluye remisión completa con recuperación incompleta de plaquetas [CRp] y remisión completa con recuperación hematológica incompleta [CRi]) después de terapia de inducción/consolidación.
    E.1.1.1Medical condition in easily understood language
    AML is cancer of myeloid line of blood cells characterized by rapid growth of abnormal white blood cells that accumulate in bone marrow and interfere with production of normal blood cells.
    Cáncer de células sanguíneas de línea mieloide con crecimiento rápido de glóbulos blancos anormales acumulados en la médula ósea interfiriendo en la producción normal de células sanguíneas normales.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10000886
    E.1.2Term Acute myeloid leukemia
    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
    The primary objective is to compare relapse-free survival (RFS) between subjects with FLT3/ITD AML in first complete remission (CR1) without transplant and who are randomized to receive gilteritinib or placebo beginning after completion of induction/consolidation chemotherapy for a 2-year period.
    El objetivo principal es comparar la supervivencia sin recidiva (RFS) entre sujetos con leucemia mieloide aguda (AML) con mutaciones del gen FLT3 (FMS-like tyrosine kinase 3) / duplicación interna en tándem (ITD) en primera remisión completa (CR1), sin trasplante y que son aleatorizados a recibir gilteritinib o placebo tras la finalización de un periodo de dos años de quimioterapia de inducción/consolidación.
    E.2.2Secondary objectives of the trial
    Key Secondary Objective:
    - Compare overall survival (OS) in subjects treated with gilteritinib as maintenance therapy after induction/consolidation with those treated with placebo.
    Additional Secondary Objectives:
    - Event-free survival (EFS), AEs, clinical laboratory, vital signs, electrocardiograms (ECGs) and Eastern Cooperative Oncology Group (ECOG) performance scores.
    - Examine the relationship of minimal residual disease (MRD), as determined using a next-generation sequencing (NGS) platform specific to FLT3/ITD mutations, with RFS and OS.
    El objetivo secundario clave es:
    - Comparar la supervivencia global (OS) en sujetos tratados con gilteritinib como tratamiento de mantenimiento tras inducción/consolidación con aquellos sujetos tratados con placebo.
    Los objetivos secundarios son:
    Evaluar la seguridad y la eficacia de gilteritinib frente a placebo en cuanto a:
    - Supervivencia sin acontecimientos (EFS), acontecimientos adversos (AE), resultados de los análisis clínicos de laboratorio, constantes vitales, electrocardiogramas (ECG) y puntuaciones del estado funcional del Eastern Cooperative Oncology Group (ECOG).
    - Examinar la relación de la enfermedad mínima residual (MRD), determinada utilizando una plataforma de nuevas tecnologías de secuenciación (NGS) específica para las mutaciones FLT3/ITD, con la supervivencia sin recidiva (RFS) y la supervivencia global (OS).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Retrospective Pharmacogenomics Substudy (Optional)
    The PGx research that may be conducted in the future with acquired blood samples and/or buccal swab is exploratory. The objective of this research will be to analyze or determine genes of relevance to clinical response, pharmacokinetics, and toxicity/safety issues. By analyzing genetic variations, it may be possible to predict an individual subject’s response to treatment in terms of efficacy and/or toxicity.

    Pharmacokinetic sampling substudy:
    Sparse (predose) pharmacokinetic samples will be collected in all subjects.
    Additional ECGs and/or time-matched plasma samples will be collected in a subset of approximately 90 subjects (targeting approximately 60 subjects in the gilteritinib arm and 30 subjects in the placebo arm) at the following visits and time points:
    - Day 15 – 4 hours (+/- 1 hour) postdose
    - Day 29 – 4 hours (+/- 1 hour) postdose
    Subestudio Retrospectivo Farmacogenómico(Opcional)
    Se podría realizar en un futuro una investigación exploratoria farmacogenómica con las muestras de sangre y/o frotis bucal recogidas. El objetivo de esta investigación será analizar o determinar genes de relevancia en la respuesta clínica, farmacocinética y toxicidad/seguridad. Analizando las variaciones genéticas, podría ser posible predecir la respuesta individual de un paciente a un tratamiento en terminos de eficacia y/o toxicidad.

    Subestudio de muestras farmacocinéticas:
    Se recogerán muestras dispersas (predosis) de farmacocinética de todos los pacientes.
    Adicionalmente se recogerán electrocardiogramas y/o muestras de plasma en función del tiempo en un grupo de 90 pacientes (teniendo como objetivo 60 pacientes aproximadamente en el brazo de gilteritinib y 30 pacientes en el brazo de placebo) en las siguientes visitas y tiempos de medición:
    - Día 15 – 4 horas (+/- 1 hora) postdosis
    - Día 29 – 4 horas (+/- 1 hora) postdosis
    E.3Principal inclusion criteria
    1. Written informed consent must be obtained from the subject or legally authorized representative prior to any study-related procedures (including withdrawal of prohibited medication, if applicable).
    2. Subject is considered an adult according to local regulation at the time of signing informed consent form (ICF).
    3. Subject consents to allow access to his or her diagnostic bone marrow aspirate or peripheral blood sample and/or the DNA derived from that sample, if available, that may be used to validate a companion diagnostic test that is being developed in parallel with gilteritinib.
    4. Subject has confirmed morphologically documented AML in CR1 (including CRp and CRi). For the purposes of enrollment, CR will be defined as < 5% blasts in the bone marrow with no morphologic characteristics of acute leukemia (e.g., Auer rods) in the bone marrow with no evidence of extramedullary disease such as central nervous system involvement or granulocytic sarcoma.
    5. Subject will not proceed with transplantation as either a decision not to proceed with transplantation has been made either on the recommendation of the treating physician or by the patient or a suitable donor could not be identified.
    6. Subject is < 2 months from the start of the last cycle of consolidation and should have completed the recommended number of consolidations per local practice.
    7. Subject has had no use of investigational agents, with the exception of FLT3 inhibiting agents during induction and/or consolidation therapy, within the prior 4 weeks.
    8. Subject has had presence of the FLT3/ITD activating mutation in the bone marrow or peripheral blood as determined by the local institution at diagnosis.
    9. Subject has an ECOG performance status 0 to 2.
    10. Subject must meet the following criteria as indicated on the clinical laboratory tests:
    - Serum creatinine </= 1.5 x institutional upper limit of normal (ULN), or if serum creatinine outside normal range, then glomerular filtration rate (GFR) > 40 mL/min/1.73m2 as calculated with the 4-parameter Modification of Diet in Renal Disease (MDRD) equation.
    - Serum total bilirubin </= 2.5 mg/dL, except for subjects with Gilbert's syndrome.
    - Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x ULN.
    - Serum potassium and serum magnesium >/= institutional lower limit of normal (LLN).
    - Absolute neutrophil count (ANC) >/= 500/μl and platelets >/= 20000/mcl (unsupported by transfusions).
    11. Subject is suitable for oral administration of study drug.

    For Inclusion Criteria 12-17 see Protocol
    1. Obtención del consentimiento informado por escrito del sujeto o de su representante legal, antes de la práctica de cualquier procedimiento del estudio (incluida la retirada de medicamentos prohibidos, si procede).
    2. El sujeto se considera adulto de acuerdo con la reglamentación local en el momento de obtención del consentimiento informado (ICF).
    3. El sujeto consiente el acceso a su muestra diagnóstica de aspirado de médula ósea o de sangre periférica y/o al ADN derivado de dicha muestra, si está disponible, que pueden emplearse para validar una prueba diagnóstica asociada al tratamiento que se está desarrollando en paralelo con gilteritinib.
    4. El sujeto tiene leucemia mieloide aguda en CR1 (que incluye CRp y CRi) confirmada morfológicamente y documentada. A efectos de reclutamiento, CR se define como < 5% de blastocitos en médula ósea, sin características morfológicas de leucemia aguda (por ejemplo, bastones de Auer) en la médula ósea y sin evidencia de enfermedad extramedular, como afectación del sistema nervioso central o sarcoma granulocítico.
    5. El sujeto no procederá al trasplante bien porque se ha decidido no realizar el trasplante (por recomendación del médico responsable del paciente o a petición del paciente) o bien porque no se ha podido identificar a un donante compatible.
    6. Han transcurrido < 2 meses desde el comienzo del último ciclo de consolidación del sujeto y debería haber concluido el número recomendado de consolidaciones según la práctica local.
    7. El sujeto no ha recibido medicamentos en investigación, a excepción de inhibidores de FLT3 durante la inducción y/o consolidación, en las 4 semanas anteriores.
    8. El sujeto presentó mutación activadora de FLT3/ITD en médula ósea o en sangre periférica, determinada en el centro, en el momento del diagnóstico.
    9. El sujeto tiene un estado funcional del ECOG entre 0 y 2.
    10. El sujeto debe cumplir los siguientes criterios relativos a los análisis clínicos de laboratorio:
    - Creatinina sérica </= 1,5 x límite superior de normalidad del centro (ULN) o, si la creatinina sérica está fuera del rango normal, entonces la velocidad de filtrado glomerular (GFR) > 40 mL/min/1,73 m2 calculada mediante la ecuación de 4 parámetros del estudio “Modificación de la Dieta en la Enfermedad Renal” (MDRD).
    - Bilirrubina total sérica </= 2,5 mg/dL, excepto para aquellos sujetos con el síndrome de Gilbert.
    - Aspartato-aminotransferasa (AST) y alanina-aminotransferasa (ALT) en suero < 3 x límite superior de la normalidad del centro (ULN).
    - Potasio sérico y magnesio sérico >/= límite inferior de la normalidad del centro (LLN).
    - Recuento absoluto de neutrófilos (ANC) >/= 500/μl y plaquetas >/= 20000/mcl (sin transfusiones).
    11. El sujeto es apto para la administración oral del fármaco del estudio.

    Refiérase al Protocolo para consultar los criterios de inclusión del 12 al 17.
    E.4Principal exclusion criteria
    1. Subject has had prior allogeneic transplant.
    2. Subject has QTcF interval > 450 msec (average of triplicate determinations).
    3. Subject with Long QT Syndrome.
    4. Subject with hypokalemia and hypomagnesemia at screening (defined as values below LLN).
    5. Subject has clinically active central nervous system leukemia.
    6. Subject is known to have human immunodeficiency virus infection.
    7. Subject has active hepatitis B or C.
    8. Subject has an uncontrolled infection. If a bacterial or viral infection is present, the subject must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to randomization. If a fungal infection is present, the subject must be receiving definitive systemic anti-fungal therapy and have no signs of progressing infection for 1 week prior to randomization.
    9. Subject has progressing infection defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
    10. Subject has uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia, congestive heart failure New York Heart Association (NYHA) class 3 or 4 or subject has a history of congestive heart failure NYHA class 3 or 4 in the past, unless a screening echocardiogram or multigated acquisition (MUGA) scan performed within 1 month prior to study entry results in a left ventricular ejection fraction that is >/= 45%.
    11. Subject requires treatment with concomitant drugs that are strong inducers of cytochrome P450 (CYP) 3A.
    12. Subject requires treatment with concomitant drugs that are strong inhibitors or inducers of P-glycoprotein (P-gp) with the exception of drugs that are considered absolutely essential for the care of the subject.
    13. Subject requires treatment with concomitant drugs that target serotonin 5-hydroxytryptamine receptor 1 (5HT1R) or 5-hydroxytryptamine receptor 2B (5HT2BR) or sigma nonspecific receptor with the exception of drugs that are considered absolutely essential for the care of the subject.

    For Exclusion Criteria 14-16 see Protocol
    1. El sujeto ha recibido un trasplante alogénico previo.
    2. El sujeto presenta un valor del intervalo QT corregido con la fórmula de Fridericia (QTcF) >450 ms (promedio de tres determinaciones)
    3. El sujeto presenta síndrome del QT largo.
    4. El sujeto presenta hipopotasemia e hipomagnesiemia en la selección (definidas como valores por debajo del LLN).
    5. El sujeto presenta leucemia del sistema nervioso central clínicamente activa.
    6. El sujeto presenta una infección comprobada por el virus de la inmunodeficiencia humana.
    7. El sujeto presenta hepatitis B o C activa.
    8. El sujeto presenta una infección activa no controlada. En caso de infección bacteriana o vírica, el paciente debe estar recibiendo un tratamiento definitivo y no debe presentar signos de empeoramiento de la infección durante las 72 horas previas a la aleatorización. En caso de infección fúngica, el paciente debe estar recibiendo un tratamiento antifúngico sistémico definitivo y no debe presentar signos de empeoramiento de la infección durante la semana previa a la aleatorización.
    9. El sujeto tiene una infección progresiva, definida como inestabilidad hemodinámica atribuible a sepsis o nuevos síntomas, empeoramiento de los hallazgos de la exploración física o hallazgos radiográficos atribuibles a infección. No se interpretará como infección progresiva la fiebre persistente sin otros signos o síntomas.
    10. El sujeto presenta angina no controlada o arritmias ventriculares severas no controladas, evidencia electrocardiográfica de isquemia aguda o insuficiencia cardiaca congestiva de clase 3 o 4 de la New York Heart Association (NYHA), o el sujeto tiene antecedentes de insuficiencia cardiaca congestiva de clase 3 o 4 de la NYHA, a menos que presente una fracción de eyección del ventrículo izquierdo >/= 45% según un ecocardiograma efectuado en la selección o una ventriculografía nuclear (MUGA) realizada en el mes anterior a la entrada en el estudio.
    11. El sujeto precisa tratamiento con fármacos concomitantes que sean inductores potentes del citocromo P450 (CYP)3A.
    12. El sujeto precisa tratamiento con fármacos concomitantes que sean inhibidores o inductores potentes de la glucoproteína P (P-gp), excepto los fármacos que se consideren absolutamente esenciales para tratar al sujeto.
    13. El sujeto precisa tratamiento con fármacos concomitantes dirigidos a los receptores 1 (5HT1R) o 2B (5HT2BR) de la serotonina (5-hidroxitriptamina) o al receptor sigma inespecífico, excepto los fármacos que se consideren absolutamente esenciales para tratar al sujeto

    Refiérase al Protocolo para consultar los Criterios de Exclusión del 14 al 16.
    E.5 End points
    E.5.1Primary end point(s)
    Relapse-free survival (RFS)
    Leukemia relapse will be defined as bone marrow blasts 5% or higher (not attributable to regenerating bone marrow), any circulating blasts, any extramedullary blast foci as per Revised International Working Group (IWG) criteria.
    Supervivencia sin recidiva (RFS)
    La recidiva de leucemia se definirá como la presencia de blastocitos en médula ósea (no atribuibles a médula ósea regenerativa) igual o superior al 5%, presencia blastocitos circulantes, todo foco extramedular de blastocitos según los criterios del Revised International Working Group (IWG).
    E.5.1.1Timepoint(s) of evaluation of this end point
    RFS: the time from randomization until relapse or death from any cause, whichever comes first.
    Supervivencia sin recidiva (RFS): periodo desde la aleatorización hasta la recidiva o el fallecimiento por cualquier causa, lo que ocurra primero.
    E.5.2Secondary end point(s)
    Key Secondary Endpoints:
    - Overall survival (OS)
    Additional secondary efficacy endpoints:
    - Event-free survival (EFS)
    - Minimal residual disease (MRD)
    Safety Endpoints
    - AEs
    - Serum chemistry, hematology, coagulation and urinalysis
    - Vital signs
    - ECGs
    - Physical examination findings
    - Eastern Cooperative Oncology Group (ECOG) performance status
    Criterio secundario clave de valoración:
    - Supervivencia global (OS), definida como el periodo desde la aleatorización hasta el fallecimiento por cualquier causa.
    Criterios secundarios de valoración:
    - Supervivencia sin acontecimientos (EFS)
    - Enfermedad mínima residual (MRD)
    Criterios de valoración de la seguridad:
    - Acontecimientos adversos (AE)
    - Bioquímica sérica, hematología, coagulación y análisis de orina
    - Constantes vitales
    - ECG
    - Hallazgos de los exámenes físicos.
    - Puntuaciones del estado funcional del ECOG
    E.5.2.1Timepoint(s) of evaluation of this end point
    OS: the time from randomization until death from any cause.
    Supervivencia global (OS): period desde la aleatorización hasta la muerte por cualquier causa.
    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 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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA111
    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
    Australia
    Brazil
    Canada
    Chile
    Croatia
    Czech Republic
    Denmark
    France
    Germany
    Greece
    Hungary
    Israel
    Italy
    Japan
    Korea, Democratic People's Republic of
    Poland
    Portugal
    Romania
    Serbia
    Spain
    Sweden
    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 end of trial in all participating countries is defined as the last subject’s last contact.
    El fin de studio en todos los paises participantes está definido como el ultimo contacto del ultimo paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 55
    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 308
    F.4.2.2In the whole clinical trial 555
    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 Decision2017-02-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-06
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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