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    Summary
    EudraCT Number:2019-001976-12
    Sponsor's Protocol Code Number:FLAG-QUIDA
    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:2019-07-26
    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 number2019-001976-12
    A.3Full title of the trial
    A multicenter, prospective, non-randomized, Phase I-II trial to assess the efficacy and safety of the combination of oral quizartinib and the FLAG-IDA chemotherapy regimen in first relapsed/refractory acute myeloid leukemia (R/R AML) patients
    Estudio multicéntrico, prospectivo, no aleatorizado, fase I-II para evaluar la eficacia y la seguridad de la combinación de quizartinib oral con el esquema de quimioterapia FLAG-IDA en pacientes con leucemia mieloide aguda en primera recidiva o refractarios (LMA R/R).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to assess the efficacy and safety of the combination of a drug call quizartinib with chemotherapy (FLAG-IDA) in patients with acute myeloid leukemia that has not responded to the first treatment or that has returned after the first treatment
    Ensayo clínico para valorar la eficacia y la seguridad de la combinación del medicamento quizartinib con la quimioterapia (FLAG-IDA) en pacientes con leucemia mieloide aguada que no ha respondido al primer tratamiento o que ha reaparecido tras el primer tratamiento
    A.4.1Sponsor's protocol code numberFLAG-QUIDA
    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 SponsorFundación Pethema
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportFundación Pethema
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación Pethema
    B.5.2Functional name of contact pointGestión de proyectos
    B.5.3 Address:
    B.5.3.1Street AddressHospital Clínico San Carlos. 2ª Sur, C/ Profesor Martín Lagos s/n
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28040
    B.5.3.4CountrySpain
    B.5.4Telephone number+34699 835 437
    B.5.5Fax number+3491 391 33 83
    B.5.6E-mailcarmen@fundacionpethema.es
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/09/622
    D.3 Description of the IMP
    D.3.1Product nameQuizartinib
    D.3.2Product code AC220
    D.3.4Pharmaceutical form 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 INNQUIZARTINIB
    D.3.9.1CAS number 950769-58-1
    D.3.9.2Current sponsor codeAC220
    D.3.9.3Other descriptive nameQUIZARTINIB
    D.3.9.4EV Substance CodeSUB89721
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin 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.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/09/622
    D.3 Description of the IMP
    D.3.1Product nameQuizartinib
    D.3.2Product code AC220
    D.3.4Pharmaceutical form 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 INNQUIZARTINIB
    D.3.9.1CAS number 950769-58-1
    D.3.9.2Current sponsor codeAC220
    D.3.9.3Other descriptive nameQUIZARTINIB
    D.3.9.4EV Substance CodeSUB89721
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    relapsed/refractory acute myeloid leukemia
    leucemia mieloide aguda en primera recidiva o refractarios
    E.1.1.1Medical condition in easily understood language
    acute myeloid leukemia that has not responded to the first treatment or that has returned after the first treatment
    leucemia mieloide aguda que no ha respondido al primer tratamiento o que ha reaparecido tras el primer tratamiento
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase I: To find the recommended Phase II dose (RP2D)
    Phase II: To assess the rate of CR/CRi after one cycle of FLAG-QUIDA
    Fase I: Determinar la dosis recomendada para la Fase II (RP2D)
    Fase II: Evaluar la proporción de CR/CRi tras un ciclo de FLAG-QUIDA
    E.2.2Secondary objectives of the trial
    • To assess the rate of CR/CRi with MRD negativity after one cycle of induction.
    • To compare the rate of CR/CRi achieved in the Phase II cohort with a matched historical control (among more than 460 patients treated with FLAG-IDA in the PETHEMA Foundation registry).
    • To assess OS at 1 and 2 years.
    • To assess safety and tolerability of the schedule.
    • To assess DFS (time to events, death in CR or relapse, whichever occurs the first), EFS
    (resistance, death in CR or relapse, whichever occurs the first), CIR, non-relapse mortality
    • To assess long term follow-up (i.e., 3 years).
    • To assess the rate of MRD negativity pre-HSCT.
    • To assess the feasibility of a maintenance schedule in the HSCT and non-HSCT setting.
    • Sub-analyses in different populations (FLT3-ITD, secondary AML, NPM1, IDH positive, and
    according to the type of relapse)
    • Other secondary objectives
    • Evaluar la proporción de CR/CRi con MRD negativa tras un ciclo de inducción.
    • Comparar la proporción de CR/CRi alcanzada en la Fase II con la de un control histórico
    emparejado (entre más de 460 pacientes tratados con FLAG-IDA en el registro de
    PETHEMA).
    • Evaluar la OS al año y a los 2 años.
    • Evaluar la seguridad y eficacia del esquema FLAG-QUIDA.
    • Evaluar el DFS (tiempo hasta evento, muerte durante remisión o recidiva, cualquiera que
    ocurra antes, EFS (resistencia, muerte durante remisión o recidiva, cualquiera que suceda
    antes), incidencia acumulada de recidiva, mortalidad no relacionada con recidiva.
    • Evaluar el seguimiento a largo plazo (es decir, 3 años).
    • Evaluar la proporción de sujetos con MRD negativa previa al alloSCT.
    • Evaluar la viabilidad del esquema de mantenimiento en el contexto postrasplante y en el
    caso de no practicar alloSCT.
    • Otros objetivos secundarios
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent in accordance with national, local, and institutional guidelines. The patient must provide informed consent prior to the first screening procedure. Informed consent form must be signed by the patient and the Investigator.
    2. Patients aged 18 to 70 years old at the time of screening.
    3. First R/R AML defined as:
    • First relapse after frontline intensive chemotherapy (with or without prior alloSCT), irrespectively of the duration of the first CR. Patients previously treated with a FLT3 inhibitor different from quizartinib, can be included.
    • First refractory disease (defined as patients not achieving at least a PR after first induction cycle and/or not achieving CR/CRi after first 2 cycles). Patients previously treated with a FLT3 inhibitor different from quizartinib, can be included.
    4. Non-APL AML.
    5. Considered for intensive approach as per Investigator judgment.
    6. ECOG 0-2.
    7. No contraindications for quizartinib.
    8. No contraindications for intensive chemotherapy.
    9. No severe organ function abnormalities.
    10. No active relevant GVHD.
    11. For the Phase II, FLT3-ITD patients will represent 50% of the study cohort (FLT3-TKD are not excluded but included in the FLT3-ITD-WT group).
    12. Female patients of child-bearing potential must have a negative serum pregnancy test at screening and agree to use reliable methods of contraception upon enrollment, during the treatment period and for 6 months following the last dose of investigational drug or
    cytarabine, whichever is later.
    13. Male patients must use a reliable method of contraception (if sexually active with a female of child-bearing potential) upon enrollment, during the treatment period, and for 6 months following the last dose of investigational drug or cytarabine, whichever is later.
    14. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and
    other study procedures.
    1. Consentimiento informado por escrito según normativa local, nacional e institucional. El paciente debe otorgar su consentimiento antes del primer procedimiento de screening. Deberá firmarse y fecharse tanto por el paciente como por el Investigador.
    2. Pacientes con edad comprendida entre los 18 y los 70 años cumplidos en el momento del screening.
    3. LMA R/R en primer episodio definida como:
    • Primera recidiva tras primera línea de quimioterapia intensiva (con o sin alloSCT previo), independientemente de la duración de la primera remisión completa. Los pacientes previamente tratados con un inhibidor de FLT3 diferente de quizartinib pueden ser incluidos.
    • Primera enfermedad refractaria (definida como aquel paciente que no alcance al menos una remisión parcial tras primer ciclo de inducción y/o que no alcance CR/CRi tras 2 ciclos de inducción). Los pacientes previamente tratados con un inhibidor de FLT3 diferente de quizartinib pueden ser incluidos.
    4. LMA no promielocítica.
    5. Que puedan recibir tratamiento intensivo a juicio del Investigador.
    6. ECOG 0-2.
    7. Sin contraindicaciones para recibir quizartinib.
    8. Sin contraindicaciones para recibir quimioterapia intensiva.
    9. Sin disfunción orgánica grave.
    10. Sin enfermedad injerto contra huésped activa relevante.
    11. Durante la Fase II, los pacientes FLT3-ITD representarán el 50% de la cohorte del estudio
    (los pacientes FLT3-TKD no serán incluido sino considerados como parte del grupo FLT3-ITD-WT).
    12. Las pacientes con posibilidad de quedarse embarazadas deberán tener una prueba de embarazo en suero negativa en el screening y comprometerse a emplear métodos de anticoncepción fiables una vez incluidas en el estudio, durante el tratamiento y hasta 6 meses después de la última dosis del fármaco en investigación o de citarabina, (la que fuera última).
    13. Los pacientes varones deben emplear un método fiable de anticoncepción (si son sexualmente activos con mujeres que puedan quedar embarazadas) a la inclusión en el estudio, durante el tratamiento y hasta 6 meses después de la última dosis del fármaco en investigación o de citarabina, (la que fuera última).
    14. Voluntad y capacidad de cumplir con las visitas, tratamientos, pruebas de laboratorio y resto
    de procedimientos programados durante el estudio.
    E.4Principal exclusion criteria
    1. Patients with genetic diagnosis of acute promyelocytic leukemia.
    2. Blastic phase of bcr/abl chronic myeloid leukemia.
    3. Patients with other neoplastic disease, for whom the Investigator has clinical suspicion of active disease at the time of enrollment. Note: Patients with adequately treated early stage squamous cell carcinoma of the skin, basal cell carcinoma of the skin, or cervical intraepithelial neoplasia are eligible for this study. Hormonal or adjuvant therapies will be allowed for breast cancer or prostate cancer if they are on a stable dose for at least 2 weeks prior to first dose.
    4. Presence of any severe psychiatric disease or physical condition/comorbidity that, according to the physician´s criteria, contraindicates the inclusion of the patient in the clinical trial
    5. Serum creatinine > or = 250 μmol/l (> or = 2.5 mg/dL) (unless it is attributable to AML activity).
    6. Bilirubin, alkaline phosphatase, or SGOT >3 times the upper normal limit (unless it is attributable to AML activity).
    7. Uncontrolled or significant cardiovascular disease, including any of the following:
    − Symptomatic bradycardia of less than 50 beats per minute, unless the subject has a pacemaker.
    − QTcF >450 ms at screening. Note: QTcF will be derived from the mean of triplicate readings.
    − Diagnosis of or suspicion of long QT syndrome (including family history of long QT syndrome)
    − History of clinically relevant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes).
    − History of second- (Mobitz II) or third-degree heart block (subjects with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker).
    − History of uncontrolled angina pectoris or myocardial infarction within 6months prior to Screening.
    − History of New York Heart Association Class 3 or 4 heart failure.
    − Complete left bundle branch block.
    − Right bundle branch and left anterior hemiblock (bifascicular block)
    − Infarction (MI) within 3 months.
    − Systolic blood pressure > or = 180 mmHg or diastolic blood pressure > o =110 mmHg
    − A previously known left ventricle ejection fraction <45%
    8. Uncontrolled (i.e., clinically unstable) infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; however, prophylactic use of these agents is acceptable even if parenteral.
    9. Active hepatitis B or hepatitis C infection.
    10. Previously known and documented human immunodeficiency virus (HIV) infection (HIV testing is not required as part of this study).
    11. Active acute or chronic GVHD requiring prednisone >10 mg or equivalent corticosteroid daily
    12. Any patients with known significant impairment in gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of quizartinib
    13. History of hypersensitivity to any excipients in the quizartinib tablets.
    14. Females who are pregnant or breastfeeding.
    15. Isolated extramedullary R/R AML.
    16. Only applicable to patients screened after the first cohort of 34 patients of the Phase II has been achieved (e.g., FLT3-ITD negative): patients must have a confirmation of FLT3-ITD status at relapse, and this must correspond to the non-achieved cohort (e.g. FLT3-ITD positive).
    1. Pacientes con el diagnóstico genético de leucemia promielocítica aguda.
    2. Fase blástica de una leucemia mieloide crónica bcr/abl.
    3. Pacientes con otras enfermedades neoplásicas de las que el Investigador tenga sospecha clínica de actividad en el momento de la inclusión. Nota: los pacientes con carcinoma de células escamosas o de células basales cutáneo o con neoplasia intraepitelial cervical adecuadamente tratados son elegibles para este estudio. Los tratamientos hormonales o adyuvantes para cáncer de mama o de próstatas serán permitidos si los pacientes están recibiendo dosis estable durante al menos 2 semanas previas a la primera dosis del estudio.
    4. Presencia de cualquier enfermedad psiquiátrica o condición/comorbilidad física graves, que según el criterio del médico, contraindique la inclusión del paciente en el estudio.
    5. Creatinina sérica > o =250 μmol/l (> o = 2.5 mg/dL) (salvo que fuera atribuible a la propia actividad de la LMA).
    6. Bilirrubina, fosfatasa alcalina, o GOT >3 veces el límite superior de la normalidad (salvo que fuera atribuible a la propia actividad de la LMA).
    7. Enfermedad cardiovascular no controlada o significativa, que incluye cualquiera de las siguientes:
    − Bradicardia sintomática de menos de 50 latidos por minuto, salvo que el sujeto tuviera un marcapasos.
    − QTcF >450 ms en el screening. Nota: el QTcF se obtendrá a partir de la media tres ECGs.
    − Diagnóstico de sospecha de síndrome del QT alargado (incluyendo historia familiar del mismo).
    − Antecedente de arritmia ventricular clínicamente relevante (como taquicardia ventricular, fibrilación ventricular o Torsade de Pointes).
    − Antecedente de bloqueo cardiaco de segundo grado Mobitz II o de tercer grado (los sujetos con marcapasos son elegibles si no tienen antecedente de síncope o de arritmias clínicamente relevantes mientras usan el marcapasos).
    − Antecedente de angina de pecho no controlada o de infarto de miocardio en los 6 meses previos al screening.
    − Insuficiencia cardiaca de grado NYHA 3 o 4.
    − Bloqueo completo de rama izquierda.
    − Bloqueo de rama derecho y hemibloqueo de rama anterior izquierda (bloqueo bifascicular).
    − Infarto de miocardio en los 3 meses previos.
    − Presión arterial sistólica ≥180 mmHg o diastólica > o = 110 mmHg
    − Fracción de eyección del ventrículo izquierdo conocida de menos del 45%.
    8. Infección no controlada (por ejemplo, clínicamente inestable) que necesite antibióticos, antivirales o antifúngicos parenterales una semana antes de la primera dosis de inducción; sin embargo, el uso profiláctico de estos agentes es aceptable incluso si se administran parenteralmente.
    9. Infección activa por virus de la hepatitis B o C.
    10. Infección previamente conocida y documentada por el virus de la inmunodeficiencia humana (VIH) (la prueba del VIH no es necesaria como parte de este estudio).
    11. Enfermedad injerto contra huésped aguda o crónica activa que necesite de >10 mg diarios de prednisona o de su equivalente corticoide.
    12. Cualquier paciente con una alteración/enfermedad importante conocida de la función gastrointestinal que pueda alterar significativamente la absorción de quizartinib.
    13. Antecedente de hipersensibilidad a alguno de los excipientes de los comprimidos de quizartinib.
    14. Mujeres embarazadas o que estén dando el pecho.
    15. Leucemia mieloide aguda extramedular aislada refractaria/recidivante.
    16. Sólo aplicable a los pacientes en screening tras haber completado la primera cohorte de 34 pacientes en la Fase II (ej. FLT3-ITD negativos): los pacientes deben tener una confirmación de su estado FLT3-ITD en el momento de la recidiva, y éste debe corresponder a la cohorte que aún falte por completar (en el ejemplo serían los FLT3-ITD positivos).
    E.5 End points
    E.5.1Primary end point(s)
    Phase I: to find the maximum tolerated dose of the combination of quizartinib and FLAG-IDA regimen (FLAG-QUIDA)

    Phase II: to assess the rate of CR/CRi after one cycle of FLAG-QUIDA
    Fase I: búsqueda de la máxima dosis tolerada de la combinación de quizartinib y FLAG-IDA (FLAG-QUIDA)

    Fase II: evaluar la tasa de CR/CRi tras un ciclo de FLAG-QUIDA
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase I: by completion of each cohort
    Phase II: after one cycle
    Fase I: tras completar cada cohorte
    Fase II: tras un ciclo
    E.5.2Secondary end point(s)
    - Disease-free survival (DFS), defined as time from the first documentation of remission to the documentation of disease recurrence or death
    - Overall survival (OS), defined as the number of days from randomization until death from any cause
    - Supervivencia libre de enfermedad, definida como el tiempo desde la primera documentación de remisión a la documentación de recurrencia o muerte

    - Supervivencia global, definida como el número de días desde la aleatorización hasta la muerte por cualquier causa
    E.5.2.1Timepoint(s) of evaluation of this end point
    At each study visit
    En cada visita del estudio
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    phase I / II study
    ensayo fase I / II
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open 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.8.2.4Number of treatment arms in the trial1
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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
    Last Patient Last Visit
    Última Visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    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 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: 82
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state83
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 92
    F.4.2.2In the whole clinical trial 92
    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)
    Standard of care for the disease, at the discretion of the investigator
    Tratamiento estándard de la enfermedad, a criterio de investigador
    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 Decision2019-09-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-04
    P. End of Trial
    P.End of Trial StatusOngoing
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