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    Summary
    EudraCT Number:2018-002773-21
    Sponsor's Protocol Code Number:89Zr-TLX250-003
    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:2019-08-09
    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 number2018-002773-21
    A.3Full title of the trial
    A confirmatory, prospective, open-label, multi-centre phase 3 study to evaluate diagnostic performance of 89Zirconium-labelled girentuximab(89Zr-TLX250) to non-invasively detect clear cell renal cell carcinoma (ccRCC) by positron emission tomography/CT (PET/CT) imaging in patients with indeterminate renal masses (ZIRCON study)
    Un estudio de fase III multicéntrico, de confirmación, prospectivo y abierto para evaluar el rendimiento de diagnóstico de girentuximab etiquetado con zirconio-89 ( 89 Zr-TLX250) para detectar de manera no invasiva el carcinoma de células renales constituido por células claras (ccRCC) mediante tomografía por emisión de positrones/TC (PET/TC) en pacientes con masas
    renales indeterminadas (estudio ZIRCON)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    89Zirconium-labelled girentuximab (89Zr-TLX250) is a new diagnostic imaging agent which has a radionuclide (zirconium-89) linked with a drug known as girentuximab. The drug is known to be taken up by clear cell renal cell carcinoma. This product would be administered and then a scan of the body made by a PET/CT machine. This study is to determine the ability of the administered zirconium-89 girentuximab to correctly identify the nature of the known or suspected cancer within your kidney.
    El girentuximab etiquetado con zirconio-89 ( 89 Zr-TLX250) es un nuevo agente diagnóstico por imagen que tiene un radionucleótido (zirconio-89) unido a un medicamento llamado girentuximab. Se sabe que el medicamento es captado por células de los carcinomas renales. Se administrará el producto y se hará un scaner del cuerpo mediante PET/TAC. En este estudio se determinará la habilidad del girentuximab etiquetado con zirconio-89 para identificar la naturaleza de las células cancerosas del riñón
    A.3.2Name or abbreviated title of the trial where available
    89Zr-TLX250 for PET/CT imaging of ccRCC
    89Zr-TLX250 para PET/TAC en ccRCC
    A.4.1Sponsor's protocol code number89Zr-TLX250-003
    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 SponsorTELIX International Pty Ltd
    B.1.3.4CountryAustralia
    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 supportTelix International Pty Ltd
    B.4.2CountryAustralia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationABX-CRO advanced pharmaceutical services
    B.5.2Functional name of contact pointclinical trials information
    B.5.3 Address:
    B.5.3.1Street AddressBlasewitzer Str. 78-80
    B.5.3.2Town/ cityDresden
    B.5.3.3Post code01307
    B.5.3.4CountryGermany
    B.5.4Telephone number003493934169700
    B.5.5Fax number00493512144415
    B.5.6E-mailinfo@abx-cro.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 name89Zr-TLX250 (synonyms: 89Zr-girentuximab, 89Zr-DFO-TFP-GTX)
    D.3.2Product code 89Zr-TLX250
    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 INNZIRCONIUM-89
    D.3.9.3Other descriptive nameZIRCONIUM-89
    D.3.9.4EV Substance CodeSUB130861
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number37
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGIRENTUXIMAB
    D.3.9.3Other descriptive nameGIRENTUXIMAB
    D.3.9.4EV Substance CodeSUB129650
    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) Yes
    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 Yes
    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
    Patients with an indeterminate renal mass (IRM) detected on contrast-enhanced abdominal MR imaging or equivalent imaging modality as part of the standard of care (ultrasound is not acceptable), clinically suspicious for renal cell carcinoma and scheduled for lesion resection as part of the regular diagnostic work-up/clinical care.
    Pacientes con una masa renal indeterminada (MRI) detectada mediante RM abdominal con contraste o equivalente como parte del estándard de cuidados médicos (no se acepta ecografía), con sospecha clínica de carcinoma de células renales y programado para resección como parte del proceso diagnóstico y clínico habitual
    E.1.1.1Medical condition in easily understood language
    Patients with an indeterminate renal mass (IRM) detected during imaging, clinically suspicious for renal cell carcinoma and scheduled for lesion resection
    Pacientes con una masa renal indeterminada (MRI) detectada durante un estudio por imagen y que sea sospechosa de ser un carcinoma de células renales, programado para resección de la lesión
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    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
    1. To evaluate sensitivity and specificity of PET/CT imaging with 89Zr-TLX250 to non-invasively detect ccRCC in patients with indeterminate renal masses, using histology as standard of truth.
    1. Evaluar la sensibilidad y especificidad de las pruebas de imagen por PET/TC con 89 Zr-TLX250 para detectar de manera no invasiva el ccRCC en pacientes con masas renales indeterminadas, utilizando la histología como estándar de referencia.
    E.2.2Secondary objectives of the trial
    1. To determine sensitivity and specificity of 89Zr-TLX250 PET/CT imaging to detect ccRCC in the subgroup of patients with indeterminate renal masses of < o = 2 cm in largest diameter
    2. To determine positive predictive value (PPV), negative predictive value (NPV), and accuracy of 89Zr-TLX250 PET/CT imaging to detect ccRCC in patients with indeterminate solid renal masses
    3. To identify a standardized uptake value (SUV) cut-off for 89Zr TLX250, suitable to discriminate ccRCC from non-ccRCC
    4. To evaluate the correlation between 89Zr-TLX250 SUVs and degree of histological CAIX expression
    5. To determine inter-reader variability of diagnostic assessments of 89Zr-TLX250 PET/CT images, when performed by multiple readers
    6. To determine intra-reader variability of diagnostic assessment of 89Zr-TLX250 PET/CT images
    7. To establish safety and tolerability of 89Zr-TLX250 in patients with indeterminate renal masses.
    1. Determinar sensibilidad y especificidad de las pruebas de imagen por PET/TC con 89Zr-TLX250 para detectar el ccRCC en subgrupo de pacientes con MRI < o = 2cm de diámetro mayor
    2. Determinar valor predictivo positivo (VPP), el valor predictivo negativo (VPN) y la precisión de las pruebas de imagen PET/TC con 89Zr-TLX250 para detectar el ccRCC en pacientes con masas renales sólidas indeterminadas
    3. Identificar punto de corte del valor de captación estandarizado (SUV) para 89Zr-TLX250, adecuado para distinguir el ccRCC de lo que no lo es
    4. Evaluar correspondencia entre los SUV de 89Zr-TLX250 y grado de expresión de CAIX histológica
    5. Determinar variabilidad entre lectores de evaluaciones de diagnóstico de las imágenes PET/TC con 89Zr-TLX250, cuando se realizan mediante varios lectores
    6. Determinar variabilidad en un mismo lector de evaluación de diagnóstico de imágenes PET/TC con 89Zr-TLX250
    7. Establecer seguridad y tolerabilidad de 89 Zr-TLX250 en pacientes con MRI
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Included in the given study protocol (for the sub-study no separate objectives)
    89Zr-TLX250 PET/CT imaging
    Abdominal PET/CT scans including the kidneys will be acquired over 20 minutes in a single bed position if possible at a single time point on Day 5 +/+ 2 post administration (p.a.) of 89Zr-TLX250 using static image acquisition and low dose CT.
    Patients found to have evidence of N1 or M1 disease may undergo additional whole body PET/CT imaging (skull base to mid-thigh) as part of a sub-study using 6-8 bed positions with 10 minutes acquisition time per bed position at the discretion of the treating clinician in the intent to support comprehensive staging. The additional scan if requested by the treating physician needs to be completed within 7 days of the administration of the investigational product. The additional images collected will be included as a sub-study analysis for the purpose of the study. In cases, where staging results in a cancellation of the planned nephrectomy, patients need to be replaced.
    Incluido en el protocolo (no hay objetivos separados para el sub-estudio)
    imagen por PET/TAC con 89Zr-TLX250
    Se tomarán PET/TAC abdominales, incluidos los riñones, durante 20 minutos en una sola poisición en la cama, si es posible, en un solo momento en el día 5 +/- 2 después de la administración de 89Zr-TLX250 mediante la adquisición de imágenes estáticas y la tomografía computarizada de baja dosis.
    Los pacientes con evidencia de enfermedad N1 o M1 pueden someterse a imágenes adicionales de PET / TAC en todo el cuerpo (desde la base del cráneo hasta la mitad del muslo) como parte de un subestudio que utiliza 6-8 posiciones en la cama con 10 minutos de tiempo de adquisición por posición a discreción del médico, con la intención de apoyar la estadificación. El escaneo adicional si lo solicita el médico debe completarse dentro de los 7 días posteriores a la administración del producto en investigación. Las imágenes adicionales recopiladas se incluirán como un análisis de subestudio para los fines del estudio. En los casos en que la estadificación resulte en la cancelación de la nefrectomía planificada, los pacientes deben ser reemplazados.
    E.3Principal inclusion criteria
    All patients must meet all of the following criteria:
    1. Written and voluntarily given informed consent
    2. Male or female > or = 18 years of age
    3. Imaging evidence of a single indeterminate renal mass of < o = 7 cm in largest diameter (tumour stage cT1), on MRI or equivalent standard of care imaging with contrast agent, not older than 90 days on Day 0, but performed before any screening procedure, suspicious for ccRCC.
    4. Scheduled for lesion resection as part of regular diagnostic work-up within 90 days from planned 89Zr-TLX250 administration.
    5. Negative serum pregnancy tests in female patients of childbearing potential at screening. Confirmation of negative pregnancy test result from urine within 24 hours prior to receiving investigational product.
    6. For patients included in France only, verification and confirmation of their affiliation with a social security
    7. Sufficient life expectancy to justify nephrectomy.
    8. Consent to practise double-barrier contraception until a minimum of 42 days after 89Zr-TLX250 administration.
    1. Consentimiento informado ofrecido voluntariamente y por escrito.
    2. Hombre o mujer > o = 18 años.
    3. Evidencia mediante prueba de imagen de una única masa renal indeterminada < o = 7 cm en su mayor diámetro (etapa del tumor cT1), en RM o prueba de imagen equivalente con agente de contraste realizada 90 días antes del Día 0 como máximo, pero antes de cualquier procedimiento de selección, y con sospecha de ccRCC.
    4. Con resección de la lesión programada como parte de la exploración de diagnóstico habitual en el plazo de 90 días a partir de la administración prevista de 89 Zr-TLX250.
    5. Pruebas negativas de embarazo en suero en mujeres en edad fértil en el momento de la selección. Confirmación de resultados negativos de pruebas de embarazo en orina dentro de las 24 horas anteriores a recibir el producto en fase de investigación.
    6. Solo para los pacientes incluidos en Francia, verificación y confirmación de su afiliación a la seguridad social.
    7. Una expectativa de vida suficiente que justifique la nefrectomía.
    8. Adoptar un método anticonceptivo de doble barrera hasta un mínimo de 42 días tras la administración de 89 Zr-TLX250.
    E.4Principal exclusion criteria
    A patient will be excluded from participation in the trial if one or more of the following criteria are met:
    1. A bioptic procedure only (rather than partial or total nephrectomy) planned for histological species delineation of IRM 2. Renal mass known to be a metastasis of another primary tumour.
    3. Active non-renal malignancy requiring therapy during the time frame of the study participation.
    4. Chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to the planned administration of 89Zr -TLX250 or continuing adverse effects (> grade 1) from such therapy (Common Terminology Criteria for Adverse Events [CTCAE] version 5.0).
    5. Planned antineoplastic therapies (for the period between administration of 89Zr-TLX250 and imaging).
    6. Exposure to murine or chimeric antibodies within the last 5 years.
    7. Previous administration of any radionuclide within 10 half-lives of the same
    8. Serious non-malignant disease (e.g. psychiatric, infectious, autoimmune or metabolic), that may interfere with the objectives of the study or with the safety or compliance of the subject, as judged by the investigator
    9. Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the study.
    10. Exposure to any experimental diagnostic or therapeutic drug within 30 days from the date of planned administration of 89Zr TLX250
    11. Women who are pregnant or breastfeeding.
    12. Known hypersensitivity to girentuximab or DFO (desferoxamine)
    13. Renal insufficiency with GFR < or = 60 mL/min/ 1.73 m²
    14. Vulnerable patients (e.g. being in detention)
    1. Solo un procedimiento bióptico (en lugar de nefrectomía parcial o total) planificado para determinar el tipo histológico de la MRI.
    2. Se ha confirmado que la masa renal es una metástasis de otro tumor primario.
    3. Una neoplasia maligna no renal activa que requiera terapia durante el periodo de participación en el estudio.
    4. Quimioterapia, radioterapia o inmunoterapia en las 4 semanas anteriores a la administración planificada de 89 Zr-TLX250 o continuación de los efectos adversos (> grado 1) de dicha terapia (criterios comunes de terminología para acontecimientos adversos [CTCAE] versión 5.0).
    5. Terapias antineoplásicas planificadas (para el periodo entre la administración de 89 Zr-TLX250 y la prueba de imagen).
    6. Exposición a anticuerpos murinos o quiméricos en los últimos 5 años.
    7. Administración previa de cualquier radionucleido en el plazo de 10 semividas del mismo.
    8. Enfermedad no maligna grave (p. ej., psiquiátrica, infecciosa, autoinmune o metabólica), que pueda interferir con los objetivos del estudio, con la seguridad del sujeto o con el cumplimiento del tratamiento por parte del sujeto, a criterio del investigador.
    9. Deterioro mental que pueda afectar a su capacidad de otorgar el consentimiento informado y cumplir con los requisitos del estudio.
    10. Exposición a cualquier fármaco experimental, de diagnóstico o terapéutico en un plazo de 30 días a partir de la fecha de administración planificada de 89 Zr-TLX250.
    11. Mujeres que estén embarazadas o en periodo de lactancia.
    12. Hipersensibilidad confirmada a girentuximab o DFO (deferoxamina).
    13. Insuficiencia renal con GFR < o = 60 mL/min/ 1,73 m².
    14. Pacientes vulnerables (p. ej., por estar en prisión).
    E.5 End points
    E.5.1Primary end point(s)
    The primary study objective is to evaluate the diagnostic efficacy of 89Zr-TLX250 as a non-invasive diagnostic tool for the detection of clear cell renal carcinoma.
    El objetivo primario es evaluar la sensibilidad y especificidad de las pruebas de imagen por PET/TC con 89 Zr-TLX250 para detectar de manera no invasiva el ccRCC
    E.5.1.1Timepoint(s) of evaluation of this end point
    Treatment: IMP administered on Day 0
    Imaging visit: Day 5 +/- 2 days (PET/CT imaging)
    Tratamiento: administración del medicamento en investigación el día 0
    visita de imagen: Día 5 +/- 2 (imagen por PET/TAC)
    E.5.2Secondary end point(s)
    Test performance parameters (sensitivity, specificity, positive and negative predictive values, accuracy), will be determined considering visually determined qualitatitive 89Zr-TLX250 tumour uptake (yes/no), and histology (ccRCC+/ ccRCC-) as standard of truth.
    Parámetros de rendimiento (sensibilidad, especificidad, valores predictivos positivos y negativos, precisión) que se determinarán visualmente considerando la captación cualitativa de 89Zr-TLX250 por el tumor(sí / no) e histología (ccRCC + / ccRCC-) como estándar de verdad.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Treatment: IMP administered on Day 0
    Imaging visit: Day 5 ± 2 days (abdominal PET/CT imaging)
    Surgery visit: any time after imaging visit, but no later than Day 90 p.a. (Surgical resection material will be sent to local pathology for routine histological work-up (H&E staining, histological diagnosis: ccRCC vs. non-ccRCC). Central pathology service, for independent confirmation of histological diagnosis. In addition, CAIX expression.
    Tratamiento: administración del medicamento en investigación el día 0
    visita de imagen: Día 5 +/- 2 (imagen por PET/TAC)
    Visita de cirugía: en cualquier momento después de la visita de imágenes, pero a más tardar el día 90. (El material de resección quirúrgica se enviará al patólogo del hospital para el estudio histológico de rutina (tinción H&E, diagnóstico histológico: CCCCR versus no CCCC). El patólogo central se usará para confirmación independiente del diagnóstico histológico. Además, la expresión de CAIX.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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
    Australia
    Canada
    European Union
    Turkey
    United Kingdom
    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
    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 years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 168
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 84
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 168
    F.4.2.2In the whole clinical trial 252
    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)
    89Zr-TLX250 is under clinical development as a tracer for renal tumour masses and metastases using PET Imaging. Patients enrolled are treated according to current clinical practice. Following completion of involvement in this study there are no limitations placed on the ongoing therapy.
    89Zr-TLX250 está bajo desarrollo clínico como trazador de masas tumorales renales y metástasis usando imágenes por PET. Los pacientes incluidos se tratarán según el estándard de cuidado habitual. Tras completar la participación en el ensayo no habrá ninguna limitación en cuanto al tratamiento a seguir por el paciente.
    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 Decision2020-02-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-15
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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