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    Summary
    EudraCT Number:2018-003146-17
    Sponsor's Protocol Code Number:QGC001-2QG4
    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:2019-04-12
    Trial results View 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 number2018-003146-17
    A.3Full title of the trial
    A Phase 2, Double-blind, Active-controlled, Dose-titrating Efficacy and Safety Study of Firibastat (QGC001) Compared to Ramipril Administered Orally, Twice Daily, Over 12 Weeks to Prevent Left Ventricular Dysfunction after Acute Myocardial Infarction
    Un estudio de fase II, doble ciego, controlado con principio activo sobre la seguridad y la eficacia del ajuste de dosis de Firibastat (QGC001) comparado con Ramipril administrados por vía oral dos veces al día durante 12 semanas para prevenir la disfunción ventricular izquierda tras un infarto agudo de miocardio
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Quantum Genomics Firibastat (QGC001) or Ramipril after Acute Myocardial Infarction for Prevention of Left Ventricular Dysfunction (QUORUM)
    Quantum Genomics Firibastat (QGC001) o Ramipril tras un infarto agudo de miocardio para la prevención de la disfunción ventricular izquierda (QUORUM)
    A.4.1Sponsor's protocol code numberQGC001-2QG4
    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 SponsorQuantum Genomics
    B.1.3.4CountryFrance
    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 supportQuantum Genomics
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationQuantum Genomics
    B.5.2Functional name of contact pointMedical Project Manager
    B.5.3 Address:
    B.5.3.1Street Address33 avenue du Maine
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75015
    B.5.3.4CountryFrance
    B.5.6E-mailstephanie.desbrandes@quantum-genomics.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 nameFiribastat
    D.3.2Product code QGC001
    D.3.4Pharmaceutical form Capsule, hard
    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 INNFiribastat
    D.3.9.1CAS number 648927-86-0
    D.3.9.2Current sponsor codeQGC001
    D.3.9.4EV Substance CodeSUB33157
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFiribastat
    D.3.2Product code QGC001
    D.3.4Pharmaceutical form Capsule, hard
    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 INNFiribastat
    D.3.9.1CAS number 648927-86-0
    D.3.9.2Current sponsor codeQGC001
    D.3.9.4EV Substance CodeSUB33157
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name Triatec®
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi SPA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.4Pharmaceutical form Capsule, hard
    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 INNRAMIPRIL
    D.3.9.1CAS number 87333-19-5
    D.3.9.4EV Substance CodeSUB10248MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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
    Prevention of left ventricular dysfunction after acute anterior myocardial infarction
    Prevención de la disfunción ventricular izquierda después de un infarto agudo de miocardio anterior
    E.1.1.1Medical condition in easily understood language
    Prevention of left ventricular dysfunction after acute anterior myocardial infarction
    Prevención de la disfunción ventricular izquierda después de un infarto agudo de miocardio anterior
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparison of the effects of twice daily (bis in die [BID]) oral administration of 2 doses of firibastat to those of BID oral administration of ramipril on the change from Baseline in left ventricular ejection fraction (LVEF) assessed by cardiac magnetic resonance imaging (CMRI) on Day 84
    Comparacion de los efectos de la administración oral dos veces al día (bis in die [2vd]) de 2 dosis de firibastat con los de la administración oral 2vd de ramipril en el cambio desde el inicio en la fracción de eyección ventricular izquierda (FEVI) evaluada por resonancia magnética cardíaca (RMC) el día 84.
    E.2.2Secondary objectives of the trial
    To compare the effects of BID administration of firibastat and ramipril on:
    - the change from Baseline to Day 84 in left-ventricle end-diastolic and end-systolic volumes assessed by CMRI
    - the change from Baseline to Day 84 in average peak of longitudinal and
    circumferential strain (assessed by CMRI) in the infarcted segments
    - infarct mass (assessed by CMRI) at Day 84
    - major cardiac event (MACE): combined clinical endpoint of cardiovascular death, myocardial infarction (MI), and cardiac hospitalization over 84 days
    - the change from Baseline to Day 84 in N-terminal pro b-type natriuretic peptide (NT proBNP), procollagen type III aminoterminal peptide (PIIINP), and C reactive protein (CRP)
    - the slope of decrease in copeptin blood level change between Baseline and Day 84.

    To compare the safety of firibastat and ramipril
    Comparar los efectos de la administración 2vd de firibastat y ramipril en:
    - el cambio desde el inicio hasta el día 84 en los volúmenes diastólico final y sistólico final del ventrículo izquierdo evaluados por RMC.
    - el cambio desde inicio hasta el día 84 en el valor máximo medio de la deformación longitudinal y circunferencial (evaluado por RMC) en los segmentos infartados.
    - la masa del infarto (evaluada por RMC) el día 84.
    - el acontecimiento cardíaco mayor (MACE): criterio de valoración clínico combinado de muerte cardiovascular, infarto de miocardio (IM) y hospitalización cardíaca durante 84 días.
    - el cambio desde el inicio hasta el día 84 en el péptido natriurético tipo pro-B N terminal (NT proBNP), el péptido aminoterminal de procolágeno tipo III (PIIINP) y la proteína C reactiva (PCR).
    - la pendiente de disminución del cambio en el nivel de copeptina en sangre entre el inicio y el día 84.

    Comparar la seguridad de firibastat y ramipril.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject must provide signed written informed consent.
    2. Men and women >= 18 years of age at Screening.
    3. Diagnosis of first acute anterior MI (ST-elevation myocardial infarction) defined as chest pain >30 minutes and ST elevation ≥0.2 mV in at least 2 consecutive electrocardiogram (ECG) leads in the anterior area (DI, aVL, V1-V6).
    4. Primary PCI of the index-MI-related artery within 24 hours after the MI.
    5. Women of childbearing potential and non-surgically sterile male subjects who are sexually active must agree to use an approved highly effective form of contraception from the time of informed consent until 30 days post-dose. Approved forms of contraception include hormonal intrauterine devices, hormonal contraceptives (oral birth control pills, depot, patch, or injectable), together with supplementary double-barrier methods such as condoms or diaphragms with spermicidal gel or foam.
    6. Women of childbearing potential must have a negative serum pregnancy test result at the Screening Visit.
    1. El sujeto debe proporcionar un consentimiento informado por escrito y firmado.
    2. Hombres y mujeres >= 18 años de edad en la selección.
    3. Diagnóstico de primer IM agudo agudo anterior (infarto de miocardio con elevación del segmento ST), definido como dolor torácico >30 minutos y elevación del segmento ST ≥0,2 mV en al menos 2 electrocardiogramas (ECG) consecutivos en el área anterior (DI, aVL, V1 V6).
    4. ICP primaria de la arteria relacionada con el IM inicial en las 24 horas posteriores al IM agudo.
    5. Las mujeres en edad fértil y los sujetos varones no estériles quirúrgicamente que sean sexualmente activos deben estar de acuerdo en usar un método anticonceptivo de alta eficacia aprobado desde el momento del consentimiento informado hasta 30 días después de la última dosis. Los métodos anticonceptivos aprobados incluyen dispositivos hormonales intrauterinos, anticonceptivos hormonales (píldora anticonceptiva orales, depot, parche o inyección) junto con métodos complementarios de doble barrera, como preservativos o diafragmas con gel o espuma espermicidas.
    6. Las mujeres en edad fértil deben tener un resultado negativo en la prueba de embarazo en suero que se lleva a cabo en la visita de selección.
    E.4Principal exclusion criteria
    1. Body mass index >45 kg/m².
    2. Subject is hemodynamically unstable or has cardiogenic shock.
    3. Subjects with clinical signs of HF (Kilipp III and IV).
    4. Systolic blood pressure <100 mmHg at Inclusion Visit.
    5. Early primary PCI of the index-MI-related artery performed within 3 hours after MI.
    6. Subjects treated with angiotensin-converting-enzyme inhibitor (ACE-I), angiotensin-receptor blocker (ARB), or sacubitril/valsartan prior to the index magnetic resonance imaging. Note: if treatment was for HTN, ACE-I/ARB should be stopped, and, if necessary, another therapeutic class can be prescribed for HTN. If the ACE-I/ARB was prescribed for congestive HF, the subject is not considered eligible; if the ACE-I/ARB prescribed for another reason cannot be stopped, the subject is not eligible for study inclusion.
    7. Subjects scheduled for implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy, or pacemaker within the next 3 months. If an ICD is indicated for ventricular arrhythmia during the course of the study, a life vest, when possible, should be prescribed and the ICD scheduled after study completion.
    8. Subjects with any contraindication related to the CMRI procedure (devices or metal foreign bodies, including pacemaker, defibrillator) including severe claustrophobia according to the lists/safety rules of the local MRI departments.
    9. Female who is breast-feeding, pregnant, or planning to become pregnant during the study.
    10. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years.
    11. Alanine aminotransferase (ALT) or alkaline phosphatase >3 x upper limit of normal (ULN) or a total bilirubin >= 2 x ULN (unless secondary to Gilbert’s syndrome) at the Screening Visit.
    12. Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2, as calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula at the Screening Visit.
    13. History of any blood disorder, other than sickle cell trait, causing hemolysis or unstable red blood cells (e.g., malaria, babesiosis, hemolytic anemia, thalassemia, or sickle cell anemia).
    14. Clinical evidence of thyroid disease, thyroid hormone therapy that is not stable >=4 weeks prior to Screening, or a thyroid-stimulating hormone (TSH) level <0.75 x lower limit of normal or >1.5 x ULN.
    15. History of alcohol or drug abuse within the 3 months prior to the Screening Visit that would interfere with study participation or lead to decreased compliance with study procedures or IP intake in the investigator’s opinion.
    16. Participation in another clinical study involving an investigational drug within 30 days prior to Screening, or if a subject plans to participate in another clinical study within 30 days of discontinuation of the IP.
    17. Any condition that in the opinion of the investigator would interfere with study participation, may pose a risk to the subject, or would make study participation not in the best interest of the subject.
    18. Subjects with a life expectancy of less than 1 year per investigator’s discretion.
    19. Any subject who, in the opinion of the investigator, will not be able to follow the protocol.
    1. Índice de masa corporal ≤45 kg/m².
    2. El sujeto es hemodinámicamente inestable o tiene choque cardiógeno.
    3. Sujetos con signos clínicos de IC (Kilipp III y IV).
    4. Tensión arterial sistólica <100 mm Hg en la visita de inclusión.
    5. ICP primaria temprana de la arteria relacionada con el IM inicial realizada en las 3 horas posteriores al IM agudo.
    6. Sujetos tratados con inhibidores de la enzima conversora de angiotensina (IECA), bloqueadores de los receptores de angiotensina (BRA) o sacubitrilo/valsartán antes de la resonancia magnética inicial. Nota: Si el tratamiento era por HTN, se deben suspender los IECA/BRA y, si es necesario, se puede recetar otra clase terapéutica para esta afección. Si se recetaron IECA/BRA por IC congestiva, no se considera apto al sujeto; si los IECA/BRA recetados por otro motivo no pueden suspenderse, el sujeto no es apto para ser incluido en el estudio.
    7. Sujetos programados para recibir un desfibrilador cardioversor implantable (DCI), tratamiento de resincronización cardíaca o marcapasos en los 3 meses próximos. Si está indicado el uso de un DCI para una arritmia ventricular durante el transcurso del estudio, se debe recetar un chaleco salvavidas, cuando sea posible, y programar el DCI una vez terminado el estudio.
    8. Sujetos con alguna contraindicación relacionada con el procedimiento de RMC (dispositivos o cuerpos extraños metálicos, incluidos marcapasos y desfibriladores), como claustrofobia grave de acuerdo con las listas/reglas de seguridad de los departamentos locales de RMC.
    9. Mujeres en periodo de lactancia, embarazadas o que tienen previsto quedarse embarazadas durante el estudio.
    10. Antecedentes personales patológicos de cáncer (excepto carcinoma basocelular) y/o tratamiento para el cáncer en los últimos 5 años.
    11. Valores de alanina aminotransferasa (ALT) o fosfatasa alcalina >3  el límite superior de la normalidad (LSN) o un valor total de bilirrubina 2  LSN (salvo que sean secundarios a síndrome de Gilbert) en la visita de selección.
    12. Tasa de filtración glomerular estimada (TFGe) <30 ml/min/1,73 m2, calculada usando la fórmula Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) en la visita de selección.
    13. Antecedentes de trastornos sanguíneos, que no sea el rasgo de células falciformes, que causen hemólisis o hematíes inestables (p. ej., malaria, babesiosis, anemia hemolítica, talasemia o anemia drepanocítica).
    14. Pruebas clínicas de enfermedad de la tiroides, tratamiento con hormonas tiroideas que no esté estable 4 semanas antes de la selección o un nivel de hormona estimulante de tiroides (TSH) <0,75  límite inferior de la normalidad o >1,5  LSN.
    15. Antecedentes de abuso de alcohol o drogas en los 3 meses anteriores a la visita de selección que pudieran interferir en la participación en el estudio o producir un menor cumplimiento de los procedimientos del estudio o el uso del PEI, según la opinión del investigador.
    16. Participación en otro estudio clínico en el que se use algún fármaco en fase de investigación en los 30 días anteriores a la selección o que el sujeto tenga previsto participar en otro estudio clínico en los 30 días posteriores a la interrupción del PEI.
    17. Cualquier afección que, según la opinión del investigador, interferiría en la participación en el estudio, pudiera representar un riesgo para el sujeto o hiciera que participar en el estudio no fuera lo mejor para el sujeto.
    18. Sujetos con una esperanza de vida inferior a 1 año, a discreción del investigador.
    19. Sujetos que, en opinión del investigador, no puedan seguir el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    Change from Baseline to Day 84 in LVEF assessed by CMRI (centralized reading)
    El cambio desde el inicio hasta el día 84 en la FEVI evaluada por RMC (lectura centralizada).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 84
    Día 84
    E.5.2Secondary end point(s)
    - Change from Baseline to Day 84 in left-ventricular end-diastolic and end-systolic volumes assessed by CMRI
    - Change from Baseline to Day 84 in average peak of longitudinal and circumferential strain in the infarcted segments assessed by CMRI
    - Infarct mass at EOT (Day 84) assessed by CMRI
    - MACE (i.e., cardiovascular deaths, new MIs, and cardiac hospitalizations) as adjudicated by an independent committee
    - Change from Baseline in NT-proBNP, PIIINP, and CRP levels to Day 84
    - Slope of decrease in copeptin over time
    • El cambio desde el inicio hasta el día 84 en los volúmenes diastólico final y sistólico final del ventrículo izquierdo evaluados por RMC.
    • El cambio desde el inicio hasta el día 84 en el valor máximo medio de la deformación longitudinal y circunferencial en los segmentos infartados evaluados por RMC.
    • La masa del infarto al FdT (día 84) evaluada por RMC.
    • MACE (es decir, muertes cardiovasculares, nuevos IM y hospitalizaciones cardíacas) según la adjudicación de un comité independiente.
    • El cambio desde el inicio en los niveles de NT proBNP, PIIINP y PCR hasta el día 84.
    • Pendiente de disminución de la copeptina con el paso del tiempo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 84
    Día 84
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    Belgium
    Czech Republic
    France
    Germany
    Hungary
    Netherlands
    Poland
    Slovakia
    Spain
    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
    LPLV
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    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: 147
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 147
    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 state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 270
    F.4.2.2In the whole clinical trial 294
    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)
    After the end of the study, each subject will be treated according to standard clinical practice.
    Después del final del estudio, cada sujeto será tratado de acuerdo a la práctica clínica estándar.
    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 Decision2019-05-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-13
    P. End of Trial
    P.End of Trial StatusOngoing
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