Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2018-002851-14
    Sponsor's Protocol Code Number:QUIWI
    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:2019-06-11
    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 number2018-002851-14
    A.3Full title of the trial
    A 2:1 randomized phase II trial to compare the efficacy and safety of standard chemotherapy plus quizartinib versus standard chemotherapy plus placebo in adult patients with newly diagnosed FLT3 wild-type AML
    Estudio fase II con aleatorización 2:1 para comparar la eficacia y seguridad del tratamiento con quimioterapia estándar más quizartinib frente a quimioterapia estándar más placebo en pacientes adultos con LMA de nuevo diagnóstico con el gen FLT3 no mutado
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CIinical trial to compare the efficacy and safety of chemotherapy plus quizartinib versus chemotherapy plus placebo in patients with acute myeloid leukemia without FLT3 mutation
    Ensayo clínico para comparar la eficacia y seguridad del tratamiento con quimioterapia más quizartinib frente a quimioterapia más placebo en pacientes con leucemia mieloide aguda sin mutación en el gen FLT3.
    A.4.1Sponsor's protocol code numberQUIWI
    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 supportDaiichi Sankyo Europe GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDynamic Science S.L.
    B.5.2Functional name of contact pointDepartamento de Operaciones
    B.5.3 Address:
    B.5.3.1Street AddressAv. de Josep Tarradellas, 8-10
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08029
    B.5.3.4CountrySpain
    B.5.4Telephone number0034914561105
    B.5.5Fax number0034914561126
    B.5.6E-mailraul.m@dynasolutions.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 nameQuizartinib
    D.3.2Product code AC220
    D.3.4Pharmaceutical form 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.3.9.3Other descriptive nameQUIZARTINIB
    D.3.9.4EV Substance CodeSUB89721
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number20 to 30
    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 placeboTablet
    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
    Acute myeloid leukemia
    Leucemia mieloide aguda
    E.1.1.1Medical condition in easily understood language
    Acute myeloid leukemia
    Leucemia mieloide aguda
    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 20.0
    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
    To compare the EFS rate (failure to achieve CR/CRi after 1 or 2 induction cycles, death in CR/CRi or relapse, whichever occurs the first) between the experimental quizartinib containing schedule and standard arms
    Comparar la tasa de supervivencia libre de eventos (SLE) (fracaso en alcanzar una remisión completa [RC]/remisión completa con recuperación hematológica incompleta [RCi] tras 1 o 2 ciclos de inducción, muerte en RC/RCi o recaída, lo que antes ocurra) entre el grupo con la pauta que contiene el fármaco en investigación quizartinib y el grupo con el tratamiento estándar
    E.2.2Secondary objectives of the trial
    To determine the maximum dose tolerated and the recommended phase 2 dose
    To compare the rate of CR/CRi with MRD negativity after one cycle on induction between arms
    To compare the DFS, OS, CIR, non-relapse mortality between arms
    To assess the rate of MRD negativity after consolidation 2, off-therapy, pre-allo-SCT
    To assess the rate of molecular relapse
    To assess the feasibility of a maintenance schedule in the SCT and non-SCT setting
    Subanalyses on efficacy and safety in different populations
    To assess the impact of potential baseline factors for a response
    To evaluate early mortality
    To evaluate the impact on the use of medical resources
    To evaluate the post-remission schedules according to a predefined risk-adapted strategy
    Biological procedures to gain insight on the mechanism of action of quizartinib in FLT3-ITD-WT AML
    To evaluate the clinical benefits, safety, tolerability, and health-related quality of life (HRQOL)
    Determinar la DMT y la dosis recomendada para fase II
    Comparar la tasa de RC/RCi con negatividad de la EMR después de un ciclo de inducción entre los grupos
    Comparar la SLE, SG, IAR y mortalidad sin recaída entre los grupos
    Evaluar la tasa de negatividad de la EMR tras la consolidación 2, fuera de tratamiento y pre trasplante
    Evaluar la tasa de recidiva molecular
    Evaluar la viabilidad de una pauta de mantenimiento en el escenario de un alo-TCH y sin alo-TCH
    Subanálisis de la eficacia y la seguridad en diferentes poblaciones
    Evaluar el impacto de posibles factores basales en la respuesta
    Evaluar la mortalidad prematura
    Evaluar el impacto sobre el uso de recursos médicos
    Evaluar los programas posteriores a la remisión según una estrategia predefinida basada en el riesgo
    Procedimientos biológicos para obtener información sobre el mecanismo de acción de quizartinib
    Evaluar los beneficios clínicos, la seguridad, la tolerabilidad y la calidad de vida relacionada con la salud
    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 before the first screening procedure. The patient and the investigator must sign informed consent form.
    2. Diagnosis of untreated AML (according to the WHO 2008/2016 definition)
    3. Age ≥ 18 and ≤70 years old at the time of screening
    4. Non-FLT3-ITD (allelic ratio <0.03) at diagnosis
    5. Considered eligible to receive intensive chemotherapy as per investigator judgment
    6. ECOG 0-2
    7. No contraindications for quizartinib
    8. The subject is receiving standard “7+3" induction chemotherapy regimen as specified in the protocol
    9. No severe organ function abnormalities
    10. Not included in other first-line trials
    11. Cardiac ejection fraction ≥ 45% assessed by echocardiography or MUGA.
    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 3 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 de acuerdo con las normas nacionales, regionales y del centro. El paciente debe otorgar su consentimiento informado antes del primer procedimiento de selección. El paciente y el investigador deberán firmar el formulario de consentimiento informado.
    2. Diagnóstico de LMA no tratada (según la definición de la OMS 2008/2016).
    3. Edad ≥ 18 y ≤ 70 años en el momento de la selección.
    4. Ausencia de mutación FLT3-ITD (índice alélico < 0,03) en el momento del diagnóstico.
    5. El paciente debe ser considerado apto para recibir quimioterapia intensiva según el criterio del investigador.
    6. ECOG 0-2.
    7. Ninguna contraindicación para recibir quizartinib.
    8. El paciente está recibiendo la pauta de quimioterapia estándar de inducción “7+3” según se indica en el protocolo
    9. Sin anomalías graves en la función orgánica.
    10. El paciente no está participando en otros estudios con tratamiento de primera línea.
    11. Fracción de eyección cardíaca ≥ 45 % evaluada mediante ecocardiografía o MUGA
    12. Las mujeres con capacidad de procrear tienen que presentar una prueba de embarazo en suero negativa en la selección y aceptar utilizar métodos anticonceptivos fiables tras la inclusión, durante el periodo de tratamiento y durante 3 meses después de la última dosis del medicamento en investigación o de citarabina, lo que ocurra más tarde.
    13. Los pacientes varones deben utilizar un método anticonceptivo fiable (si mantienen relaciones sexuales con una mujer con capacidad de procrear) tras la inclusión, durante el periodo de tratamiento y durante 3 meses después de la última dosis del medicamento en investigación o de citarabina, lo que ocurra más tarde.
    14. Estar dispuesto y ser capaz de cumplir con las visitas programadas, los planes de tratamiento, las pruebas de laboratorio y otros procedimientos del estudio.
    E.4Principal exclusion criteria
    1. Patients with a genetic diagnosis of acute promyelocytic leukemia
    2. Age <18 years or >70 years
    3. ECOG performance status of 3 or 4
    4. Prior treatment for AML, except for the following allowances:
    a) Leukapheresis
    b) Treatment for hyperleukocytosis with hydroxyurea
    5. Blastic phase of bcr/abl chronic myeloid leukemia.
    6. Presence of an associated active and/or uncontrolled malignancy: patients with another neoplastic disease, for whom the Investigator has a 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 as long as they are on a stable dose for at least 2 weeks before the first dose.
    7. Known active and not controlled hepatitis B or hepatitis C infection. In the event of a positive viral load, please consult with the Sponsor
    8. Known human immunodeficiency virus (HIV) infection (HIV testing is not required as part of this study)
    9. Presence of any severe psychiatric disease or physical condition that, according to the physician´s criteria, contraindicates the inclusion of the patient into the clinical trial
    10. Serum creatinine ≥ 250 μmol/l (≥ 2.5 mg/dL) (unless it is attributable to AML activity)
    11. Bilirubin, alkaline phosphatase, or SGOT > 3 times the normal upper limit (unless it is attributable to AML activity)
    12. Uncontrolled or significant cardiovascular disease, including any of the following:
    a. Symptomatic bradycardia of fewer than 50 beats per minute, unless the subject has a pacemaker;
    b. QTcF >450 msec at Screening. Note: QTcF will be derived from the mean of triplicate readings;
    c. Diagnosis of or suspicion of long QT syndrome (including family history of long QT syndrome);
    d. Systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥ 110 mmHg;
    e. History of clinically relevant ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, or Torsade de Pointes)
    f. History of a 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)
    g. An ejection fraction <45%
    h. History of uncontrolled angina pectoris or myocardial infarction within 6 months prior to Screening
    i. History of New York Heart Association Class 3 or 4 heart failure
    j. Right bundle branch and left anterior hemiblock (bifascicular block), complete left bundle branch block
    13. History of hypersensitivity to any excipients in the quizartinib/placebo tablets
    14. Females who are pregnant or breastfeeding
    15. Any patients with known significant impairment in gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of quizartinib.
    16. Active acute or chronic GVHD requiring prednisone >10 mg or equivalent corticosteroid daily.
    1. Pacientes con diagnóstico genético de leucemia promielocítica aguda.
    2. Edad < 18 años o > 70 años.
    3. Estado funcional del ECOG de 3 o 4.
    4. Tratamiento previo para la LMA, excepto las siguientes excepciones:
    a) Leucaféresis
    b) Tratamiento para la hiperleucocitosis con hidroxiurea
    5. Fase blástica de leucemia mieloide crónica BCR/ABL.
    6. Presencia de una neoplasia maligna asociada activa y/o no controlada: pacientes con otra enfermedad neoplásica, para quienes el investigador tiene sospecha clínica de enfermedad activa en el momento de la inclusión. Nota: los pacientes con carcinoma de células escamosas en estado incipiente, carcinoma de células basales o neoplasia intraepitelial cervical tratados adecuadamente son aptos para participar en este estudio. Se permitirá el uso de tratamientos hormonales o adyuvantes para el cáncer de mama o el cáncer de próstata, siempre que se reciban a una dosis estable durante al menos 2 semanas antes de la primera dosis
    7. Infección por el virus de la hepatitis B o hepatitis C activa y no controlada. En caso de carga viral positiva, consúltese con el promotor.
    8. Seropositividad confirmada para el virus de la inmunodeficiencia humana (VIH) (no se requieren pruebas del VIH como parte de este estudio).
    9. Presencia de cualquier enfermedad psiquiátrica o afección física grave que, según los criterios del médico, contraindique la inclusión del paciente en el estudio clínico.
    10. Creatinina sérica ≥ 250 μmol/l (≥ 2,5 mg/dl) (a menos que sea atribuible a la actividad de la LMA).
    11. Bilirrubina, fosfatasa alcalina o SGOT > 3 veces el límite superior de la normalidad (a menos que sea atribuible a la actividad de la LMA).
    12. Enfermedad cardiovascular no controlada o significativa, incluida cualquiera de las siguientes:
    a. Bradicardia sintomática de menos de 50 latidos por minuto, a menos que el paciente lleve un marcapasos.
    b. QTcF > 450 ms en la selección. Nota: el QTcF se obtendrá de la media de las lecturas por triplicado.
    c. Diagnóstico o sospecha de síndrome de QT largo (incluidos antecedentes familiares de síndrome de QT largo).
    d. Presión arterial sistólica ≥ 180 mm Hg o presión arterial diastólica ≥ 110 mm Hg.
    e. Antecedentes de arritmias ventriculares clínicamente relevantes (p. ej., taquicardia ventricular, fibrilación ventricular o Torsade de pointes).
    f. Antecedentes de bloqueo cardíaco de segundo (Mobitz II) o tercer grado (los pacientes con marcapasos son aptos si no presentan antecedentes de desmayos o arritmias clínicamente relevantes durante el uso del marcapasos).
    g. Fracción de eyección < 45 %.
    h. Antecedentes de angina de pecho no controlada o infarto de miocardio en los 6 meses previos a la selección.
    i. Antecedentes de insuficiencia cardíaca de clase 3 o 4 según la New York Heart Association.
    j. Hemibloqueo de rama derecha y anterior de rama izquierda (bloqueo bifascicular), bloqueo completo de rama izquierda.
    13. Antecedentes de hipersensibilidad a cualquier excipiente de los comprimidos de quizartinib/placebo.
    14. Mujeres embarazadas o en periodo de lactancia.
    15. Cualquier paciente con deterioro significativo de la función gastrointestinal o enfermedad gastrointestinal que pueda alterar significativamente la absorción de quizartinib.
    16. Enfermedad de injerto contra huésped (EICH) activa aguda o crónica que requiera una dosis diaria de prednisona > 10 mg o corticoide equivalente
    E.5 End points
    E.5.1Primary end point(s)
    Event-free survival (EFS): failure to achieve CR/CRi after 1 or 2 induction cycles, death in CR/CRi or relapse, whichever occurs the first)
    Supervivencia libre de eventos (SLE) (fracaso en alcanzar una remisión completa [RC]/remisión completa con recuperación hematológica incompleta [RCi] tras 1 o 2 ciclos de inducción, muerte en RC/RCi o recaída, lo que antes ocurra)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the study
    A lo largo del estudio
    E.5.2Secondary end point(s)
    - Maximum dose tolerated and recommended phase 2 dose
    - Rate of CR/CRi with MRD negativity
    - Adverse events
    - Disease Free Survival
    - Rate of MRD negativity
    - Rate of molecular relapse
    - Impact of potential baseline factors for a response
    - Early mortality
    - Use of medical resources during the treatment phase (antibiotics, transfusions, duration of hospitalization, need of central venous line)
    - Health-related quality of life
    - Dosis máxima tolerada y dosis recomendada para la fase II
    - Tasa de RC/RCi con enfermedad mínima residual negativa
    - Acontecimientos adversos
    - Supervivencia libre de enfermedad
    - Tasa de enfermedad mínima residual negativa
    - Tasa de recaída molecular
    - Impacto en la respuesta de diferentes factores basales
    - Mortalidad prematura
    - Utilización de recursos médicos durante la fase de tratamiento (antibioticos, transfusiones, duración de hospitalizaciones, necesidad de catéter venoso central):
    - Calidad de vida relacionada con la salud:
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Maximum dose tolerated and recommended phase 2 dose: maximum of 59 days since day 1 of induction chemotherapy
    - Rate of CR/CRi with MRD negativity: throughout the study
    - Adverse events: throughout the study
    - Disease Free Survival: throughout the study
    - Rate of MRD negativity: throughout the study
    - Rate of molecular relapse: throughout the study
    - Impact of potential baseline factors for a response: throughout the study
    - Early mortality: first 60 days
    - Use of medical resources during the treatment phase (antibiotics, transfusions, duration of hospitalization, need of central venous line): throughout the study
    - Health-related quality of life: throughout the study
    - DMTy dosis recomendada para la fase II: máximo de 59 días desde el día 1 del primer ciclo de inducción.
    - Tasa de RC/RCi con enfermedad mínima residual negativa: a lo largo del estudio
    - Acontecimientos adversos: a lo largo del estudio
    - SLE: a lo largo del estudio
    - Tasa de enfermedad mínima residual negativa: a lo largo del estudio
    - Tasa de recaída molecular: a lo largo del estudio
    - Impacto en la respuesta de diferentes factores basales: a lo largo del estudio
    - Mortalidad prematura: primeros 60 días
    - Utilización de recursos médicos durante la fase de tratamiento (antibioticos, transfusiones, duración de hospitalizaciones, necesidad de catéter venoso central): a lo largo del estudio
    - Calidad de vida relacionada con la salud: a lo largo 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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.7.1Other trial design description
    Fase seguridad abierta para seleccionar dosis. Fase II controlada, aleatorizada, doble ciego
    Safety phase (open label) to select phase II dose. Phase II is controlled, randomised, double blind
    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 concerned46
    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 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 years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    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: 281
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 281
    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 state257
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 281
    F.4.2.2In the whole clinical trial 281
    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. According to standard of care
    Ninguno. Según práctica clínica habitual
    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 Decision2019-06-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-05
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 19 06:37:25 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA