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    Summary
    EudraCT Number:2022-001292-14
    Sponsor's Protocol Code Number:CV029-009
    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:2022-09-26
    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 number2022-001292-14
    A.3Full title of the trial
    A Phase 2a, Open-label, Pilot Study to Evaluate Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of MYK-224 in Participants with Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction
    Estudio preliminar en fase IIa, abierto para evaluar la eficacia, la farmacocinética, la farmacodinámica, la seguridad y la tolerabilidad de MYK-224 en participantes con miocardiopatía hipertrófica sintomática y obstrucción del conducto de salida del ventrículo izquierdo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multiple Dose Study to Evaluate Efficacy, Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of MYK-224 in Participants with Symptomatic Obstructive Hypertrophic Cardiomyopathy
    Estudio de dosis múltiples para evaluar la eficacia, la farmacocinética, la farmacodinámica, la seguridad y la tolerabilidad de MYK-224 en participantes con miocardiopatía hipertrófica
    obstructiva sintomática
    A.4.1Sponsor's protocol code numberCV029-009
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1276-3555
    A.5.4Other Identifiers
    Name:INDNumber:146425
    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 SponsorMyoKardia, Inc.
    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 supportMyoKardia, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBristol-Myers Squibb International Corporation
    B.5.2Functional name of contact pointGSM-CT
    B.5.3 Address:
    B.5.3.1Street AddressParc de l'Aliance -Avenue de Finlande, 4
    B.5.3.2Town/ cityBraine-l'Alleud
    B.5.3.3Post code1420
    B.5.3.4CountryBelgium
    B.5.6E-mailclinical.trials@bms.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 nameMYK-224 (2.5 mg per 1 Tablet)
    D.3.2Product code BMS-986435
    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 INNMYK-224
    D.3.9.2Current sponsor codeBMS-986435
    D.3.9.3Other descriptive nameBMS-986435
    D.3.9.4EV Substance CodeSUB263294
    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.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 nameMYK-224 (5 mg per 1 Tablet)
    D.3.2Product code BMS-986435
    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 INNMYK-224
    D.3.9.2Current sponsor codeBMS-986435
    D.3.9.3Other descriptive nameBMS-986435
    D.3.9.4EV Substance CodeSUB263294
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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 nameMYK-224 (10 mg per 1 Tablet)
    D.3.2Product code BMS-986435
    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 INNMYK-224
    D.3.9.2Current sponsor codeBMS-986435
    D.3.9.3Other descriptive nameBMS-986435
    D.3.9.4EV Substance CodeSUB263294
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin 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
    Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction
    Miocardiopatía hipertrófica sintomática y obstrucción del conducto de salida del ventrículo izquierdo
    E.1.1.1Medical condition in easily understood language
    A kind of heart disease with enlarging of the heart and the obstruction of a cardiac tract
    Un tipo de enfermedad cardíaca con agrandamiento del corazón y la obstrucción de un tracto cardíaco
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10020871
    E.1.2Term Hypertrophic cardiomyopathy
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    -To assess the safety and tolerability of MYK-224 in participants with oHCM
    -Evaluar la seguridad y la tolerabilidad de MYK-224 en participantes con MCHO
    E.2.2Secondary objectives of the trial
    -To evaluate the effect of MYK-224 on LVOT gradient in participants with oHCM
    -To assess the PK/PD relationship of MYK-224
    -To assess the PK of MYK-224 in participants with oHCM
    -Evaluar el efecto de MYK-224 en el gradiente del TSVI en participantes con MCHO
    -Evaluar la relación FC/FD de MYK-224
    -Evaluar la FC de MYK-224 en participantes con MCHO
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Has adequate acoustic windows, to enable accurate TTEs as determined by the echocardiography core laboratory.
    -Men or women diagnosed with oHCM consistent with current American College of Cardiology Foundation/American Heart Association and European Society of Cardiology guidelines, satisfying both of the following criteria:
    -- Has unexplained left ventricular (LV) hypertrophy with nondilated ventricular chambers in the absence of other cardiac (eg, hypertension, aortic stenosis) or systemic disease and with maximal LV wall thickness ≥ 15 millimeter (mm) (or ≥ 13 mm with positive family history of hypertrophic cardiomyopathy or with a known disease-causing mutation), as determined by core laboratory interpretation.
    AND
    -- Has a LVOT peak gradient during screening as assessed by echocardiography of ≥ 50 millimeters of mercury (mm Hg) at rest, or ≥ 30 mm Hg at rest and ≥ 50 mm Hg after Valsalva maneuver (confirmed by echocardiography core laboratory interpretation).
    - Has documented LVEF ≥ 60% at the Screening visit as determined by echocardiography core laboratory.
    - Has a valid measurement of LVOT post-exercise peak gradient at screening as determined by echocardiography core laboratory.
    - NYHA functional class II or III symptoms at screening
    -Tiene ventanas acústicas adecuados para permitir ETT precisos según lo determinado por el laboratorio central de ecocardiografía.
    -Hombres o mujeres diagnosticados de MCH obstructiva según las directrices actuales de la American College of Cardiology Foundation/American Heart Association y la European Society of Cardiology, que cumplan los dos criterios siguientes:
    --Tener hipertrofia del VI sin explicación con cámaras ventriculares no dilatadas en ausencia de otra enfermedad cardíaca (p. ej., hipertensión, estenosis aórtica) o sistémica y con un grosor máximo de la pared del VI ≥ 15 mm (o ≥ 13 mm con antecedentes familiares positivos de miocardiopatía hipertrófica o con una mutación conocida que cause la enfermedad), según lo determinado por la interpretación del laboratorio central.
    Y
    -- Tener un gradiente máximo del OTSVI durante la selección evaluado mediante ecocardiografía de ≥ 50 mmHg en reposo, o ≥ 30 mmHg en reposo y ≥ 50 mmHg después de la maniobra de Valsalva (confirmado mediante la interpretación del laboratorio central de ecocardiografía).
    -Tener una FEVI documentada ≥ 60 % en la visita de selección, determinada mediante ecocardiograma en el laboratorio central.
    - Tener una medición válida del gradiente máximo del OTSVI después del ejercicio en la selección, determinada por el laboratorio central de ecocardiografía.
    - Síntomas de clase funcional II o III de la NYHA en la selección
    E.4Principal exclusion criteria
    -Presence of any medical condition that precludes exercise stress testing.
    -History of syncope or sustained ventricular tachyarrhythmia within 6 months prior to screening.
    -Known infiltrative or storage disorder causing cardiac hypertrophy that mimics HCM, such as Fabry disease, amyloidosis, or Noonan syndrome with left ventricular hypertrophy.
    - Has been successfully treated with invasive septal reduction (surgical myectomy or percutaneous alcohol septal ablation [ASA]) within 6 months prior to Screening or plans to have either of these treatments during the study (Note: Individuals with an unsuccessful myectomy or percutaneous ASA procedure performed &gt; 6 months prior to Screening may be enrolled if study eligibility criteria for LVOT gradient criteria are met).
    - Implantable cardioverter-defibrillator (ICD) placement or pulse generator change within 2 months prior to screening or planned new ICD placement during the study (pulse generator changes, if needed during the study are allowed)
    - Has a history of resuscitated sudden cardiac arrest (any time) or known history of appropriate implantable cardioverter-defibrillator (ICD discharge for life-threatening ventricular arrhythmia within 6 months prior to screening
    - Has paroxysmal, intermittent atrial fibrillation with atrial fibrillation present per the Investigator’s evaluation of the subject’s ECG at the time of Screening
    - Has persistent or permanent atrial fibrillation not on anticoagulation for at least 4 weeks prior to Screening and/or not adequately rate controlled within 6 months prior to Screening
    - Has QT interval with Fridericia correction (QTcF) &gt; 500 msec when QRS interval &lt; 120 msec or QTcF &gt; 520 msec when QRS ≥ 120 msec if participant has left bundle branch block or any other 12-lead ECG abnormality considered by the investigator to pose a risk to participant safety (eg, second-degree atrioventricular block type II)
    - Has known moderate or severe (per investigator’s judgment) aortic valve stenosis at screening
    - History of LV systolic dysfunction (LVEF &lt; 45%) at any time during their clinical course
    - Has pulmonary disease that limits exercise capacity
    - History of obstructive coronary artery disease (stenosis of &gt; 70% of luminal diameter in one or more coronary arteries).
    -Prior treatment with mavacamten or aficamten. An exception may be made in cases where myosin inhibitor use was not within 4 months of the Screening visit, and with the agreement of both the Investigator and the Sponsor Medical Monitor.
    Prior treatment with cardiotoxic agents such as anthracyclines (eg, doxorubicin) or similar
    -Presencia de cualquier afección médica que impida la prueba de esfuerzo con ejercicio.
    -Antecedentes de síncope o taquiarritmia ventricular sostenida en los 6 meses anteriores a la selección.
    -Trastorno infiltrado o de almacenamiento conocido que causa hipertrofia cardíaca que imita a la MCH, como la enfermedad de Fabry, la amiloidosis o el síndrome de Noonan con hipertrofia ventricular izquierda.
    -Haber sido tratado con éxito con reducción del tabique invasivo (miectomía quirúrgica o ablación septal percutánea con alcohol [ASA]) en los 6 meses anteriores a la selección o tener previsto recibir cualquiera de estos tratamientos durante el estudio (nota: las personas con un procedimiento de miectomía o ASA percutáneo que no se haya realizado con éxito > 6 meses antes de la selección pueden inscribirse si se cumplen los criterios de elegibilidad para el gradiente del OTSVI).
    -Colocación de un desfibrilador cardioversor implantable (DCI) o cambio del generador de pulsos en los 2 meses anteriores a la selección o nueva colocación prevista de un DCI durante el estudio (se permiten cambios en el generador de pulsos, si fuera necesario durante el estudio).
    -Tener antecedentes de parada cardíaca súbita resucitada (en cualquier momento) o antecedentes conocidos de desfibrilador cardioversor implantable adecuado (alta de DCI por arritmia ventricular potencialmente mortal en los 6 meses anteriores a la selección).
    -Tener fibrilación auricular paroxística intermitente con fibrilación auricular presente según la evaluación del investigador del ECG del sujeto en el momento de la selección.
    -Tener fibrilación auricular persistente o permanente que no esté recibiendo anticoagulación durante al menos 4 semanas antes de la selección y/o que no tenga una tasa controlada adecuada en los 6 meses antes de la selección
    -Intervalo QT con corrección de Fridericia (QTcF) > 500 ms cuando intervalo QRS < 120 ms o QTcF > 520 ms cuando QRS ≥ 120 ms si el participante tiene bloqueo de rama izquierda o cualquier otra anomalía en el ECG de 12 derivaciones que el investigador considere que supone un riesgo para la seguridad del participante (p. ej., bloqueo auriculoventricular de segundo grado de tipo II).
    -Tener estenosis de la válvula aórtica moderada o grave conocida (a criterio del investigador) en la selección.
    -Antecedentes de disfunción sistólica del VI (FEVI < 45 %) en cualquier momento durante la evolución clínica.
    -Neumopatía que limita la capacidad de hacer ejercicio.
    -Antecedentes de arteriopatía coronaria obstructiva (estenosis de > 70 % del diámetro luminal en una o más arterias coronarias).
    -Tratamiento previo con mavacamten o aficamten. Se puede hacer una excepción en los casos en que el uso de inhibidores de la miosina no haya sido en los 4 meses anteriores a la visita de selección, y con el acuerdo del investigador y el supervisor médico del patrocinador.
    -Tratamiento previo con fármacos cardiotóxicos como antraciclinas (p. ej., doxorrubicina) o algo similar
    E.5 End points
    E.5.1Primary end point(s)
    -Incidence, severity, and causality of AEs and SAEs
    -Incidence of symptomatic LVEF < 50% by TTE
    -Incidence of LVEF ≤ 30% by TTE
    -Incidence of MACE, including cardiovascular death, nonfatal stroke, nonfatal myocardial infarction
    -Incidence of hospitalizations (due to cardiovascular and non-cardiovascular events)
    -Incidence of HF events (including hospitalizations and urgent emergency room/outpatient visits for HF)
    -Incidence of atrial fibrillation/flutter (new from screening and recurrent)
    -Incidence of appropriate implantable cardioverter defibrillator therapy and resuscitated cardiac arrest
    -Incidence of ventricular tachyarrhythmias (includes ventricular tachycardia, ventricular fibrillation, and Torsades de Pointes)
    -Results of vital signs, physical exams, 12-lead ECG assessments (including HR), and clinical laboratory tests
    -Incidencia, gravedad, causalidad de los AA y AAG
    -Incidencia de FEVI sintomática < 50 % por ETT
    -Incidencia de FEVI ≤ 30 % por ETT
    -Incidencia de MACE, incluidas muerte cardiovascular, accidente cerebrovascular no mortal, infarto de miocardio no mortal
    -Incidencia de hospitalizaciones (debido a acontecimientos cardiovasculares y no cardiovasculares)
    -Incidencia de acontecimientos de IC (incluidas hospitalizaciones y visitas a urgencias/ambulatorias por IC)
    -Incidencia de fibrilación/aleteo auricular (nuevo desde la selección y recurrente)
    -Incidencia de tratamiento adecuado con desfibriladores cardioversores implantables y paro cardíaco con reanimación
    -Incidencia de taquiarritmias ventriculares (incluye taquicardia ventricular, fibrilación ventricular y torsades de pointes)
    -Resultados de constantes vitales, exploraciones físicas, evaluaciones de ECG de 12 derivaciones (incluida la FC) y pruebas analíticas clínicas
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Up to 30 days after EOT
    - Up to EOS
    - Up to EOS
    - Up to 30 days after EOT
    - Up to 30 days after EOT
    - Up to EOS
    - Up to EOS
    - Up to EOS
    - Up to EOS
    - Up to EOS
    -Hasta 30 días después del final del tratamiento
    -Hasta el final del estudio
    -Hasta el final del estudio
    -Hasta 30 días después del final del tratamiento
    -Hasta 30 días después del final del tratamiento
    -Hasta el final del estudio
    -Hasta el final del estudio
    -Hasta el final del estudio
    -Hasta el final del estudio
    -Hasta el final del estudio
    E.5.2Secondary end point(s)
    - Effect on LVOT gradient
    - PK/PD relationship
    - PK concentrations
    -Efecto sobre el gradiente del TSVI
    -Relación FC/FD
    -Concentraciones FC
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Up to EOT
    - Up to EOS
    - Up to EOS
    -Hasta el final del tratamiento
    -Hasta el final del estudio
    -Hasta el final 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 No
    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 No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tolerabilidad
    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 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.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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
    United States
    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
    End of trial is defined as the last participant last visit or scheduled procedure as shown as in the Schedule of Activities.
    El final del ensayo se define como la última visita del participante o el último procedimiento programado, tal como se indica en el programa de actividades.
    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 months8
    E.8.9.1In the Member State concerned days4
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days4
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 19
    F.4.2.2In the whole clinical trial 36
    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)
    The subjects can continue with standard approved medication for this condition.
    Los sujetos pueden continuar con la medicación estándar aprobada para esta afección.
    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 Decision2022-11-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-11-11
    P. End of Trial
    P.End of Trial StatusOngoing
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