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    Summary
    EudraCT Number:2021-003874-30
    Sponsor's Protocol Code Number:ATILA-ictus-2021
    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:2021-12-23
    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 number2021-003874-30
    A.3Full title of the trial
    RANDOMIZED MULTI-CENTER CLINICAL TRIAL TO ASSESS THE EFFECTIVENESS AND SAFETY OF TIROFIBAN VERSUS INTRAVENOUS ASPIRIN IN PATIENTS WITH ACUTE ISCHEMIC STROKE SECONDARY TO TANDEM INJURY, SUBJECT TO RECANALIZATION THERAPY THROUGH THROUGH ENDOVASCULAR TREATMENT
    ENSAYO CLÍNICO ALEATORIZADO MULTICÉNTRICO PARA VALORAR EFICACIA Y SEGURIDAD DE TIROFIBAN VERSUS ASPIRINA INTRAVENOSA EN PACIENTES CON ICTUS ISQUÉMICO AGUDO SECUNDARIO A LESIÓN EN TÁNDEM, SOMETIDOS A TERAPIA DE RECANALIZACIÓN MEDIANTE TRATAMIENTO ENDOVASCULAR.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ATILA Project: Aspirin vs Tirofiban in endovascular treatment for patients with acute ischemic stroke due to Tandem Lession.
    Proyecto ATILA: Aspirina vs Tirofibán en el tratamiento endovascular para pacientes con Ictus isquémico agudo por Lesión en tAndem
    A.4.1Sponsor's protocol code numberATILA-ictus-2021
    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 Pública Andaluza para la Gestión de la Investigación en Salud de Sevilla (FISEVI).
    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 supportInstituto de Salud Carlos III (Ministerio de Ciencia e Innovación)
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUnidad de Investigación Clínica y Apoyo a Ensayos Clínicos
    B.5.2Functional name of contact pointUICEC-HUVR
    B.5.3 Address:
    B.5.3.1Street AddressAvenida Manuel Siurot s/n
    B.5.3.2Town/ citySeville
    B.5.3.3Post code41013
    B.5.3.4CountrySpain
    B.5.4Telephone number+34955013414
    B.5.5Fax number+34955095338
    B.5.6E-maileecc.huvr@gmail.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 AGGRASTAT® (50 micrograms/ml) solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderCorrevio (UK) Ltd
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameTirofiban Agrastat ®
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTIROFIBAN HYDROCHLORIDE MONOHYDRATE
    D.3.9.1CAS number 150915-40-5
    D.3.9.3Other descriptive nameTIROFIBAN HYDROCHLORIDE MONOHYDRATE
    D.3.9.4EV Substance CodeSUB22331
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.056
    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 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 INYESPRIN®
    D.2.1.1.2Name of the Marketing Authorisation holderAristo Pharma Iberia, S.L.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameINYESPRIN®
    D.3.4Pharmaceutical form Powder for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLYSINE ASPIRIN
    D.3.9.1CAS number 62952-06-1
    D.3.9.3Other descriptive nameLYSINE ASPIRIN
    D.3.9.4EV Substance CodeSUB34053
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number900
    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
    Acute Ischemic Stroke
    Ictus isquémico agudo de circulación anterior secundario a lesión en tándem
    E.1.1.1Medical condition in easily understood language
    Acute Ischemic Stroke
    Accidente cerebrovascular isquémico agudo
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.1
    E.1.2Level LLT
    E.1.2Classification code 10055221
    E.1.2Term Ischemic stroke
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.1
    E.1.2Level PT
    E.1.2Classification code 10061256
    E.1.2Term Ischaemic stroke
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10008192
    E.1.2Term Cerebrovascular and spinal necrosis and vascular insufficiency
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10003216
    E.1.2Term Arteriosclerosis, stenosis, vascular insufficiency and necrosis
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10047065
    E.1.2Term Vascular disorders
    E.1.2System Organ Class 10047065 - Vascular 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 efficacy and safety of the use of tirofiban versus aspirin in patients with ischemic stroke secondary to tandem injury, by determining the rate of reocclusion as well as determining the rate of symptomatic bleeding defined as any hemorrhagic transformation associated with a worsening of 4 or more points on the National Institutes of Health Stroke Scale.
    Valorar la eficacia y la seguridad del uso de tirofiban frente a aspirina en pacientes con ictus isquémico secundario a lesión en tándem, mediante la determinación de la tasa de reoclusión así como la determinación de la tasa de hemorragia sintomática definida como cualquier transformación hemorrágica asociada a un empeoramiento de 4 o más puntos en la escala National Institutes of Health Stroke Scale.
    E.2.2Secondary objectives of the trial
    - Determine the rescue therapy rate in the presence of intra-stent aggregation phenomena during the procedure
    - Detection of good functional prognosis rates at 90 days in the different subgroups (defined as a score on the modified Rankin scale (mRS) between 0-2).
    - Improve the pathophysiological knowledge of the complications associated with the endovascular treatment of tandem lesions (re-occlusion) through the identification of related plasma biomarkers.
    - Assessment of any of the biomarkers identified as a therapeutic target for reocclusion.
    - Reocclusion or significant restenosis at 30 days.
    - Determinar la tasa de terapia de rescate ante la presencia de fenómenos de agregación intra-stent durante el procedimiento
    - Detección de las tasas de buen pronóstico funcional a los 90 días en los diferentes subgrupos (definido como una puntuación en la escala de Rankin modificada (mRS) entre 0-2).
    - Mejorar el conocimiento fisiopatológico de las complicaciones asociadas al tratamiento endovascular de las lesiones en tándem (re-oclusión) a través de la identificación de biomarcadores plasmáticos relacionados.
    - Valoración de alguno de los biomarcadores identificados como diana terapéutica de reoclusión.
    - Reoclusión o reestenosis significativa a los 30 días.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Sub-study of Blood Biomarkers, Version 1.0 (10/December/21).

    Objectives:
    - Improve the pathophysiological knowledge of the complications associated with the endovascular treatment of tandem lesions (re-occlusion) through the identification of related plasma biomarkers
    - Assessment of some of the biomarkers identified as a therapeutic target for reocclusion.
    Sub-estudio de Biomarcadores sanguíneos, Version 1.0 (10/December/21).

    Objetivos:
    - Mejorar el conocimiento fisiopatológico de las complicaciones asociadas al tratamiento endovascular de las lesiones en tándem (re-oclusión) a través de la identificación de biomarcadores plasmáticos relacionados

    - Valoración de alguno de los biomarcadores identificados como diana terapéutica de reoclusión.
    E.3Principal inclusion criteria
    • Patients with acute ischemic stroke of the anterior territory secondary to a tandem lesion, with an indication for thrombectomy treatment according to the current recommendations of the Clinical Practice Guidelines, and the need for cervical stent placement.
    • The intracranial occlusion locations that may be included are: carotid "T", M1 and M2 segments of the middle cerebral artery, segment A1 of the anterior cerebral artery; and in the case that the posterior cerebral artery has fetal origin and is the site of intracranial occlusion.
    • ASPECTS (Alberta Stroke Program Early computerized Tomography Score) ≥6.
    • Greater than or equal to 18 years of age.
    • Signed informed consent.
    • Pacientes con ictus isquémico agudo de territorio anterior secundario a lesión en tándem, con indicación de tratamiento de trombectomía, y necesidad de colocación de stent cervical.
    • Las localizaciones de oclusión intracraneal que podrán ser incluidas son: “T” carotídea, segmentos M1 y M2 de arteria cerebral media, segmento A1 de arteria cerebral anterior; y en el caso de que la arteria cerebral posterior tenga origen fetal y sea el lugar de oclusión intracraneal.
    • ASPECTS (Alberta Stroke Program Early CT Score) ≥6.
    • Mayor o igual a 18 años de edad.
    • Consentimiento informado firmado.
    E.4Principal exclusion criteria
    • Patients under 18 years of age.
    • Patients with ASPECTS <6.
    • Bilateral strokes or those produced by simultaneous occlusion of an artery in the anterior and posterior territory.
    • Patients whose carotid stenosis is due to a re-stenosis or reocclusion of a pre-existing cervical stent.
    • Candidate patients for carotid puncture.
    • Previous treatment with double antiplatelet therapy for another cause prior to inclusion.
    • Severe comorbidity and / or reduced life expectancy.
    • Modified Rankin scale (mRS)> 2.
    • Severe allergy to contrast medium.
    • Pregnant.
    • Patients with intracranial occlusive arteriosclerotic disease or extra or intracranial dissection.
    • Documented allergy to acetylsalicylic acid or Tirofiban.
    • Personal history of platelet penia (Platelets <100,000)
    • Concomitant anticoagulant treatment (with presence of INR (International Normalized Ratio) > 1.7 in case of anti-vitamin K treatment or taking direct oral anticoagulant <48 hours ago)
    • Medical history of the patient that carries a high risk of bleeding according to the investigator's criteria.
    • Menores de 18 años.
    • Pacientes con ASPECTS < 6.
    • Ictus bilaterales o que se produzcan por oclusión simultánea de alguna arteria de territorio anterior y posterior.
    • Pacientes cuya estenosis carotidea, sea debida a una re-estenosis o reoclusión de un stent cervical pre-existente.
    • Pacientes candidatos a punción carotidea.
    • Tratamiento previo con doble antiagregación por otra causa previa a la inclusión.
    • Comorbilidad grave y/o esperanza de vida reducida.
    • Escala de Rankin modificada (mRS) >2.
    • Alergia grave al medio de contraste.
    • Embarazadas.
    • Pacientes con enfermedad arterioclerótica oclusiva intracraneal o disección extra o intracraneal.
    • Alergia documentada a AAS o a tirofiban.
    • Antecedente personal de plaquetopenia (Plaquetas <100.000), o de haber desarrollado trombocitopenia durante la administración anterior de antagonistas de los receptores GP IIb/IIIa o de AAS iv.
    • Tratamiento anticoagulante concomitante (con presencia de INR >1.7 en caso de tratamiento con anti-vitamina K o toma de anticoagulante oral directo hace <48 horas).
    • Hemorragia activa o reciente (dentro de los 30 días previos al tratamiento antiagregante) clínicamente relevante (p. ej., hemorragia gastrointestinal).
    • Ulcera péptica activa en los 3 últimos meses.
    • Antecedente médico del paciente que conlleve elevado riesgo hemorrágico según criterio del investigador.
    E.5 End points
    E.5.1Primary end point(s)
    1. Carotid Reocclusion. Carotid reocclusion will be assessed on ultrasound doppler within first 24-36 hours after mechanical thrombectomy and it is defined by the presence at the level of the occlusion point, by a characteristic biphasic, brief and low speed pattern both in the Doppler spectrum and in color mode (color image with both orthodromic and antidromic flow, redblue just proximal to the occlusion). In addition, the image detected in mode B will show an anechoic appearance with a false appearance of permeable light, detecting the absence of flow in color and Doppler modes. In addition, carotid reocclusion will be evaluated on angio-Computerized Tomography that will demonstrate complete blockage of the artery.

    2. Platelet aggregation phenomena. Parietal irregularity in the intra-stent contrast filling.

    3. Symptomatic intracranial hemorrhage (sICH). The sICH is defined as a new intracranial hemorrhage in brain computerized tomography within hospitalization related to an National institute of Health Stroke Scale score increase >4 points compared with stroke admission.
    1. Reoclusión carotídea. La reoclusión carotídea se valorará mediante ecografía doppler en las primeras 24-36 horas tras la trombectomía mecánica y se define por la presencia, a nivel del punto de oclusión, de un patrón característico bifásico, breve y de baja velocidad tanto en el espectro Doppler como en color (imagen en color con flujo ortodrómico y antidrómico, rojo-azul justo proximal a la oclusión). Además, la imagen detectada en modo B mostrará una apariencia anecoica con una falsa apariencia de luz permeable, detectando la ausencia de flujo en el color y Doppler.La reoclusión carotídea se evaluará mediante angio-tomografía computarizada que demostrará el bloqueo completo de la arteria.

    2. Fenómenos de agregación plaquetaria. Irregularidad parietal en el relleno de contraste intra-stent.

    3. Hemorragia intracraneal sintomática: se define como una nueva hemorragia intracraneal en la tomografía computarizada de cerebro realizada durante la hospitalización relacionada con un aumento de la puntuación de la escala de accidente cerebrovascular (NIHSS) > 4 puntos en comparación con la que presentaba a su ingreso por el accidente cerebrovascular.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Carotid Reocclusion. [Time Frame: Quarterly basis]

    2. Platelet aggregation phenomena. [Time Frame: Annually (Single Evaluation)]

    3. Symptomatic intracranial hemorrhage (sICH). [Time Frame: Annually ( Single evaluation)]
    1. Reoclusión carotídea. [Evaluación trimestral]

    2. Fenómenos de agregación plaquetaria. [Anualmente (evaluación única)]

    3. Hemorragia intracraneal sintomática (SICH). [Anualmente (evaluación única)]
    E.5.2Secondary end point(s)
    Good functional prognosis. Defined as a score on the modified rankin scale (mRS) between 0-2 at 90 days.
    Buen pronóstico funcional. Definido como una puntuación en la escala de rankin modificada (mRS) entre 0-2 a los 90 días.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Quarterly basis (singe evaluation).
    Trimestral (evaluación única)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 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 concerned10
    E.8.5The trial involves multiple Member States No
    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
    LVLS
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    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: 170
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-12-23. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Under acceptance of legal representative / family member or witness
    Bajo aceptación de representante legal / familiar o ante testigo
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state240
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 240
    F.4.2.2In the whole clinical trial 240
    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
    Ninguno
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation UICEC-HUVR
    G.4.3.4Network Country Spain
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-02-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-11
    P. End of Trial
    P.End of Trial StatusOngoing
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