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    Summary
    EudraCT Number:2021-004601-47
    Sponsor's Protocol Code Number:CKJX839D12303
    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:2022-04-06
    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 number2021-004601-47
    A.3Full title of the trial
    A multi-center, randomized, double-blind, placebo controlled, parallel-group Phase IIIb study evaluating the effect of inclisiran on atherosclerotic plaque progression assessed by coronary computed tomography angiography (CCTA) in participants with a diagnosis of non-obstructive coronary artery disease without previous cardiovascular events (VICTORION-PLAQUE)
    Estudio de fase IIIb, multicéntrico, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos que evalúa el efecto de inclisirán en la progresión de la placa aterosclerótica evaluada mediante angiografía coronaria por tomografía computarizada en participantes con un diagnóstico de enfermedad arterial coronaria no obstructiva sin acontecimientos cardiovasculares previos (VICTORION-PLAQUE).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Coronary computed tomography study to assess the effect of inclisiran on atherosclerotic plaque progression in participants with a diagnosis of non-obstructive coronary artery disease without previous cardiovascular events
    Estudio para evaluar mediante tomografía computarizada coronaria el efecto de inclisirán en la progresión de la placa aterosclerótica en
    participantes con un diagnóstico de enfermedad arterial coronaria no obstructiva sin acontecimientos cardiovasculares previos.
    A.3.2Name or abbreviated title of the trial where available
    VICTORION-PLAQUE
    VICTORION-PLAQUE
    A.4.1Sponsor's protocol code numberCKJX839D12303
    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 SponsorNovartis Farmacéutica, S.A.
    B.1.3.4CountrySpain
    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 supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmacéutica, S.A.
    B.5.2Functional name of contact pointTrial Monitoring Organization (TMO)
    B.5.3 Address:
    B.5.3.1Street AddressGran vía de les Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number+34930353036
    B.5.5Fax number+34932479903
    B.5.6E-maileecc.novartis@novartis.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 Yes
    D.2.1.1.1Trade name Leqvio 284 mg solution for injection in pre-filled syringe
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameInclisiran
    D.3.2Product code KJX839
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINCLISIRAN
    D.3.9.1CAS number 1639324-62-1
    D.3.9.2Current sponsor codeKJX839
    D.3.9.3Other descriptive nameInclisiran sodium
    D.3.9.4EV Substance CodeSUB182427
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Non-obstructive coronary artery disease
    Enfermedad arterial coronaria no
    obstructiva
    E.1.1.1Medical condition in easily understood language
    atherosclerotic plaque (fatty deposits that can lead to heart disease) in the heart with less than 50% obstruction of blood flow
    Placa aterosclerótica (depósitos de grasa que pueden ocasionar enfermedad cardiovascular) en el corazón con menos del 50% de obstrucción del flujosanguíneo
    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 10011078
    E.1.2Term Coronary artery disease
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Inclisiran compared to placebo, on top of maximally tolerated statin therapy, in reducing the total coronary atheroma volume assessed by CCTA from baseline to month 24
    Superioridad de inclisirán respecto a placebo, administrado en combinación con el tratamiento máximo tolerado de estatinas, en la reducción del volumen total de ateroma coronario evaluado mediante ACTC desde la basal hasta el mes 24.
    E.2.2Secondary objectives of the trial
    - Inclisiran compared to placebo, administered on top of maximally tolerated statin therapy, in reducing the LDL-C from baseline to month 24
    - Inclisiran compared to placebo in percentage change in low attenuation plaque volume evaluated by CCTA
    - Inclisiran compared to placebo in percentage of participants experiencing progression, regression, or no change of total plaque atheroma volume (progression, regression, or no change will be defined in the SAP)
    -Inclisirán respecto a placebo, administrado en combinación con el tratamiento máximo tolerado de estatinas, en la reducción del C-LDL desde la basal hasta el mes 24.
    - Inclisirán respecto a placebo en el cambio porcentual en el volumen de placas de baja atenuación evaluado mediante ACTC.
    -Inclisirán respecto a placebo en porcentaje de participantes con progresión, regresión o sin cambios en el volumen total de placas de ateroma (rogresión, regresión o sin cambios será definido en el SAP).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent must be obtained before any assessment is performed.
    2. Male or female >/=18 years or </=80 years of age at signing of informed consent.
    3. Fasting LDL-C local lab value at the Screening Visit of either i) >/=100 mg/dL if on statin therapy but not on a maximally tolerated statin therapy; ii) >/=150 mg/dL if statin naive and without documented statin intolerance; or iii) >/=70 mg/dL if on a stable (>/=4 weeks) dose of maximally tolerated statin therapy or if statin intolerant.
    4. Participants may be pre-identified based on a CCTA or an invasive angiography that is performed as part of standard of care within 12 months prior to the participant's Screening Visit demonstrating:
    -Presence of coronary artery plaque with visual diameter stenosis <50% or
    -Coronary artery plaque with visual artery stenosis >50% but Fractional Flow Reserve (FFR) >0.8 by special wire measurement (CCTA or coronary angiography)
    5. Fasting LDL-C local lab value >/=70 mg/dL at the assessment performed during the Statin Optimization Period 3 Visit for participants going through the Statin Optimization Period.
    6. Participants having NOCA* confirmed by CCTA with FFRCT >0.8 and CT-adapted Leaman score >5** or coronary artery plaque with visual diameter stenosis >50% but with FFRCT >0.8 and CT-adapted Leaman score >5 without previous cardiovascular events.
    *=NOCA is defined as the presence of coronary artery plaque with visual diameter stenosis <50%.
    **=CT-adapted Leaman score, which includes information on lesion localization, plaque composition, degree of stenosis by CCTA is demonstrated to be an independent long-term predictor of hard cardiac events.
    A standard of care CCTA may serve as the study baseline CCTA scan if it is performed within 3 months prior to the participant's Screening Visit and meets the inclusion criteria of FFRCT >0.8 and CT-adapted Leaman score >5, which will be assessed by the Imaging Core Lab.
    7. At the Baseline Visit, participants must be on a stable (>/=4 weeks) dose of maximally tolerated statin therapy. Participants not on maximally tolerated statin therapy and who do not have documented statin intolerance can be screened but must enter the study via a Statin Optimization Period.
    1.El consentimiento informado por escrito se debe obtener antes de realizar cualquier evaluación.
    2. Hombres o mujeres >/=18 años o </=80 años de edad en el momento de la firma del consentimiento informado.
    3. Valor analítico local del C-LDL en ayunas en la visita de selección de (1) >/=100 mg/dl si recibe un tratamiento con estatinas pero no el tratamiento máximo tolerado de estatinas; (2) >/=150 mg/dl si nunca ha recibido estatina ni ha presentado una intolerancia documentada a la estatina; o (3) >/=70 mg/dl si recibe una dosis estable (>/=4 semanas) del tratamiento máximo tolerado de estatinas o si es intolerante a la estatina.
    4. Los participantes pueden ser previamente identificados basándose en la ACTC o en una angiografía invasiva realizada como parte del
    tratamiento estándar durante los 12 meses anteriores a la visita de selección del participante que demuestre:
    -Presencia de placa en las arterias coronarias con <50 % de estenosis por diámetro en la estimación visual o
    -placa en las arterias coronarias con >50 % de estenosis por diámetro en la estimación visual, pero con una reserva de flujo fraccional (RFF) >0,8 mediante medición especial con guía (ACTC o angiografía coronaria).
    5. Valor analítico local del C-LDL en ayunas >/=70 mg/dl en la evaluación realizada durante la visita 3 del periodo de optimización de estatinas en los participantes que se encuentren en el periodo de optimización de estatinas.
    6.Participantes con arteria coronaria no obstructiva (ACNO)* confirmada mediante ACTC con una RFFTC >0,8 y una puntuación de Leaman adaptada a la TC >5** o placa en las arterias coronarias con >50 % de estenosis por diámetro en la estimación visual, pero una RFFTC >0,8 y una puntuación de Leaman adaptada a la TC >5 sin acontecimientos cardiovasculares previos.
    *= ACNO se define como la presencia de placa en las arterias coronarias con <50 % de estenosis por diámetro en la estimación visual.
    **= la puntuación de Leaman adaptada a la TC, que incluye información sobre la localización de las lesiones, la composición de las placas y el grado de estenosis mediante ACTC; demuestra ser un predictor independiente a largo plazo de acontecimientos cardíacos complicados.
    Una ACTC estándar puede servir como ACTC basal del estudio si se ha
    realizado durante los 3 meses anteriores a la visita de selección del
    participante y si cumple los criterios de inclusión de una RFFTC >0,8 y una
    puntuación de Leaman adaptada a la TC >5, que se evaluará en el
    laboratorio principal de diagnóstico por imagen.
    7.En la visita basal, los participantes deben estar recibiendo una dosis estable (>/=4 semanas) del tratamiento máximo tolerado de estatinas. Los participantes que no reciban el tratamiento máximo tolerado de estatinas y que no tengan una intolerancia documentada a las estatinas pueden ser seleccionados, pero deben entrar en el estudio a través del periodo de optimización de estatinas.
    E.4Principal exclusion criteria
    1. Previous myocardial infarction (MI), or prior coronary revascularization [percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)].
    2. Planned revascularization (PCI or CABG).
    3. Previous ischemic cerebrovascular event including:
    -Prior ischemic stroke thought not to be caused by atrial fibrillation, valvular heart disease or mural thrombus.
    -History of prior percutaneous or surgical carotid artery revascularization.
    4. History of Peripheral Artery Disease (PAD):
    -Prior documentation of a resting ankle-brachial index <0.85.
    -History of prior percutaneous or surgical revascularization of an iliac, femoral, or popliteal artery.
    -Prior non-traumatic amputation of a lower extremity due to peripheral artery disease.
    5. Cardiac disorders, including any of the following:
    -Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia, atrial fibrillation) within 3 months prior to randomization that is not controlled by medication or via ablation at the time of the Screening Visit.
    -Complete left bundle branch block, high-grade atrioventricular (AV) block (e.g., bifascicular block, Mobitz type II and third-degree AV block) prior to randomization.
    6. NOCA participant who was prescreened by the Investigator with visual diameter stenosis >50% but FFR <0.8.
    7. Contraindication for CCTA (e.g., allergic reactions to the contrast dye) or CCTA not meeting entry standards after two attempts during the Baseline CCTA Visit as assessed by the Imaging Core Lab.
    8. Pacemaker or implantable cardioverter-defibrillator (ICD) in situ.
    9. Systolic Left Ventricle Ejection Fraction <30% at the Screening Visit.
    10. Uncontrolled severe hypertension: systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg prior to randomization (assessed at the Screening Visit) despite antihypertensive therapy.
    11. Heart failure New York Heart Association (NYHA) class III or class IV at the Screening Visit.
    12. Renal insufficiency (eGFR <30 mL/min/1.73m2) as measured by the Modification of Diet in Renal Disease (MDRD) formula at the Screening Visit and at the Statin Optimization 3 Visit.
    13. Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver at the Screening Visit. Participants who enter the Statin Optimization Period must have AST and ALT </=3x ULN (as defined by local laboratory reference ranges collected at the Screening Visit) and reported by the Statin Optimization Telephone Visit 1 to be allowed to continue in the Statin Optimization Period.

    Please refer to Section 5.2 of the study protocol for the complete list of exclusion criteria
    1.Infarto de miocardio (IM) previo o revascularización coronaria previa (intervención coronaria percutánea [ICP] o injerto anastomótico coronario [CABG]).
    2.Revascularización prevista (ICP o CABG).
    3.Acontecimiento cerebrovascular isquémico previo como:
    - Accidente cerebrovascular isquémico previo que no se considere causado por una fibrilación auricular, cardiopatía valvular o trombo mural.
    - Antecedentes de revascularización percutánea o quirúrgica de la arteria carótida.
    4.Antecedentes de enfermedad arterial periférica (EAP):
    - Documentación previa de un índice tobillo-brazo en reposo <0,85.
    - Antecedentes de revascularización percutánea o quirúrgica de la arteria ilíaca, femoral o poplítea.
    - Amputación no traumática previa de una extremidad inferior debida a una enfermedad arterial periférica.
    5. Trastornos cardíacos, incluyendo alguno de los siguientes:
    - Arritmias cardíacas clínicamente significativas (p. ej., taquicardia ventricular o fibrilación auricular) durante los 3 meses anteriores a la aleatorización que no estén controladas con medicamentos o mediante ablación en el momento de la visita de selección.
    - Bloqueo completo de rama izquierda, bloqueo auriculoventricular (AV) de alto grado (p. ej., bloqueo bifascicular o bloqueo AV de tipo II de Mobitz o bloqueo de tercer grado) antes de la aleatorización.
    6. Participante con ACNO que haya sido preseleccionado por el investigador con <50 % de estenosis por diámetro en la estimación visual pero una RFF <0,8.
    7. Contraindicación para la ACTC (p. ej., reacciones alérgicas al medio de contraste) o ACTC que no cumpla los requisitos de admisión después de dos intentos durante la visita de ACTC basal, evaluada en el laboratorio principal de diagnóstico por imagen.
    8. Marcapasos o desfibrilador automático implantable (DAI) in situ.
    9. Fracción de eyección del ventrículo izquierdo (FEVI) sistólica <30 % en la visita de selección.
    10. Hipertensión grave no controlada: presión arterial sistólica >180 mm Hg o presión arterial diastólica >110 mm Hg antes de la aleatorización (evaluada en la visita de selección) a pesar del tratamiento antihipertensivo.
    11. Insuficiencia cardíaca de clase III o IV de la Asociación de Cardiología de Nueva York (NYHA) en la visita de selección.
    12. Insuficiencia renal (TFGe <30 ml/min/1,73 m2) determinada mediante la fórmula de la modificación de la dieta en la enfermedad renal (MDRD) en la visita de selección y en la visita de optimización de estatinas 3.
    13. Enfermedad hepática activa definida como cualquier patología infecciosa, neoplásica o metabólica actual del hígado en la visita de selección. Los participantes que entren en el periodo de optimización de estatinas deben tener AST y ALT </=3 x LSN (según los rangos de referencia del laboratorio local recogidos en la visita de selección) y notificados en la visita telefónica de optimización de estatinas 1 para que pueda continuar en el periodo de optimización de estatinas.

    Por favor, consulte la Sección 5.2 de protocolo del estudio para ver la lista completa de criterios de exclusión.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage change from baseline to month 24 in total coronary atheroma volume
    Cambio porcentual desde la basal hasta el mes 24 en el volumen total de ateroma coronario
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to month 24.
    Desde la basal hasta el mes 24
    E.5.2Secondary end point(s)
    -percentage change in LDL-C from baseline to month 24
    -percentage change in low attenuation plaque volume evaluated by CCTA
    -percentage of participants with progression, regression, or no change of total plaque atheroma volume
    - Cambio porcentual en el C-LDL desde la basal hasta el mes 24.
    - Cambio porcentual en el volumen de placa de baja atenuación evaluado mediante ACTC.
    - Porcentaje de participantes con progresión, regresión o sin cambios en el volumen total de placa de ateroma.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From baseline to month 24.
    Desde la basal hasta el mes 24
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Brazil
    Canada
    Chile
    China
    India
    Japan
    Korea, Republic of
    United States
    Belgium
    France
    Germany
    Hungary
    Ireland
    Italy
    United Kingdom
    Spain
    Switzerland
    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
    LVLS
    Última visitas del último paciente (LVLP)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days2
    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: 330
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 270
    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 state23
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 223
    F.4.2.2In the whole clinical trial 600
    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)
    A post trial access program may be initiated to allow for the investigational drug to be made available to qualified patients participating in the study, in countries where it is not commercially available at the time of study completion.
    Podría iniciarse un programa para la continuación del tratamiento tras el ensayo en el que el fármaco en investigación podría ponerse a disposición de los pacientes aptos que participen en el estudio, en países donde no esté comercializado en el momento de la finalización del estudio
    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 Decision2022-07-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-05-13
    P. End of Trial
    P.End of Trial StatusOngoing
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