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    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2017-001828-22
    Sponsor's Protocol Code Number:101
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-02-01
    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 number2017-001828-22
    A.3Full title of the trial
    A Multicenter Phase 2/3 Trial of the Efficacy and Safety of Intracerebroventricular Radioimmunotherapy using 131I-burtomab for Neuroblastoma Central Nervous System/Leptomeningeal Metastases
    Ensayo Multicéntrico de Fase 2/3 para evaluar la seguridad y eficacia de la Radioinmunoterapia intracerebroventricular usando 131I-burtomab para Neuroblastoma del Sistema Nervioso Central / Metastasis Leptomeníngea
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial in several sites where pediatric patients with Neuroblastoma are treated with injections of 131I-burtomab (the study drug). The tolerability and efficacy of the drug will be tested.
    Ensayo clínico en varios centros donde los pacientes pediátricos con Neuroblastoma se tratan con inyecciones de 131I-burtomab (medicamento en investigación). Se evaluará la tolerabilidad y eficacia del medicamento.
    A.4.1Sponsor's protocol code number101
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03275402
    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 SponsorY-mAbs Therapeutics A/S
    B.1.3.4CountryDenmark
    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 supportY-mAbs Therapeutics A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSermes Planificacion SL
    B.5.2Functional name of contact pointUnidad de Puesta en Marcha
    B.5.3 Address:
    B.5.3.1Street AddressC/Rufino González 14, Esc.1ª-2ºD
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28037
    B.5.3.4CountrySpain
    B.5.4Telephone number+34913275025
    B.5.5Fax number+34917542721
    B.5.6E-mailstart-up@sermescro.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/17/1839
    D.3 Description of the IMP
    D.3.1Product name131I-burtomab
    D.3.2Product code 131I-murine 8H9
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPIntracerebroventricular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNburtomab
    D.3.9.1CAS number 1895083-75-6
    D.3.9.2Current sponsor code131I-burtomab
    D.3.9.3Other descriptive nameBURTOMAB
    D.3.9.4EV Substance CodeSUB188981
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.8 to 1.2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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 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 Yes
    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
    Treatment of pediatric neuroblastoma patients with CNS relapse as evidenced by CNS/LM metastases
    Tratamiento de pacientes con neuroblastoma pediátrico con recaída en el SNC como evidenciado por metástasis en el SNC/LM
    E.1.1.1Medical condition in easily understood language
    Treatment of pediatric neuroblastoma patients with CNS relapse as evidenced by CNS/LM metastases
    Tratamiento de pacientes con neuroblastoma pediátrico con recaída en el SNC como evidenciado por metástasis en el SNC/LM
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10073130
    E.1.2Term Central nervous system neuroblastoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Overall survival (OS) rate at 3 years
    Tasa de supervivencia global (SG) a los 3 años
    E.2.2Secondary objectives of the trial
    1. To evaluate the objective response rate (ORR) up to 3 years
    2. To evaluate CNS progression free survival (PFS) at 6 months
    3. To the evaluate dosimetry of 131I-burtomab
    4. To evaluate the pharmacokinetics of 131I-burtomab
    5. To evaluate safety of 131I-burtomab
    1. Evaluar la tasa de respuesta objetiva (ORR) a los 3 años
    2. Evaluar la supervivencia libre de progresión (SLP) en el SNC a los 6 meses.
    3. Evaluar la dosimetría de 131I-burtomab.
    4. Evaluar la farmacocinética del 131I-burtomab.
    5. Evaluar la seguridad del 131I-burtomab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients must have a histologically confirmed diagnosis of neuroblastmona with relapse in the CNS or LM.
    2. Patients need to have progressed in CNS/LM through induction therapy or have relapsed in CNS/LM follow induction. CNS/LM progression/ relapse is defined as LM disease or metastatic deposits in the CNS parenchyma, (excluding skull bone-based metastases)
    3. Stable systemic disease not requiring chemo/ immunotherapy as judged by the investigator
    4. Ventriculoperitoneal (VP) shunt is allowed however should be closed during IMP infusion and for approximately 5 hours after treatment and then readjusted. Closure of VP shunt is done at the discretion of the treating physician and the VP shunt should at any time based on patient safety evaluation be re-opened- at the assessment of the treating physician.
    5. Patients must be between the ages of birth and 18 years at the time of screening
    6. Patients must have a life expectancy of at least 3 months.
    7. Acceptable hematological status, (hematological support is allowed if administered at least 2 weeks before administration of 131I-burtomab), defined as:
    • Hemoglobin ≥8 g/dL
    • While blood cell count ≥1000/µL
    • Absolute neutrophil count ≥500/µL
    • Platelet count ≥50,000/µL
    8. Acceptable liver function defined as:
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 times upper limit of normal (UNL)
    • Bilirubin ≤1.5 x UNL
    9. Acceptable kidney function defined as:
    • eGFR >60 mL/min/1.73 m2 calculated by the 2009 revised Bedside Schwartz Equation (Appendix 3).
    10. Written informed consent from legal guardian(s) and/or child must be obtained in accordance with local regulations. Pediatric patients must provide assent as required by local regulations
    1. Los pacientes deben tener un diagnóstico histológicamente confirmado de Neuroblastoma con recaída en el SNC o ML.
    2. Los pacientes deben haber sufrido progresión en el SNC/ML durante la terapia de inducción o haber tenido una recaída en el SNC/ML tras de la inducción. La progresión/recaída en el SNC/ML se define como enfermedad ML o depósitos metastásicos en el parénquima del SNC (excluyendo metástasis de huesos craneales).
    3. Enfermedad sistémica estable que no requiere quimioterapia /inmunoterapia según criterio del investigador.
    4. Se admite derivación ventriculoperitoneal (VP) aunque debe estar cerrada durante la infusión del producto en investigación y durante aproximadamente 5 horas tras del tratamiento y luego reajustada. El cierre de la derivación VP se realiza a criterio del médico y su reapertura debería realizarse en cualquier momento en base a la evaluación de la seguridad del paciente, según el criterio del médico.
    5. Los pacientes deben tener entre 0 y 18 años en el momento de la selección.
    6. Los pacientes deben tener una esperanza de vida de al menos 3 meses.
    7. Estado hematológico aceptable, (se admite soporte hematológico si se administra al menos 2 semanas antes de la primera administración de 131 I-burtomab), definido como:
    • Hemoglobina ≥8 g/dL
    • Recuento de glóbulos blancos ≥1000/μL
    • Recuento absoluto de neutrófilos ≥500/μL
    • Recuento de plaquetas ≥50,000/μL
    8. Función hepática aceptable definida como:
    • Alanina aminotransferasa (ALT) y aspartato aminotransferasa (AST) ≤ 5 veces el límite superior de normalidad (LSN)
    • Bilirrubina ≤1.5 x LSN
    9. Función renal aceptable definida como:
    • eGFR >60 mL/min/1.73 m2 calculado por la Ecuación de Bedside Schwartz revisada de 2009 (apéndice 3)
    10. Consentimiento informado por escrito por el(los) tutor(es) legal(es) y/o el niño de acuerdo con las normas locales. Los niños deben dar su consentimiento según lo exigido por las normativas locales
    E.4Principal exclusion criteria
    1. Patients with primary neuroblastoma (NB) in CNS
    2. Patients must not have obstructive or symptomatic communicating hydrocephalus.
    3. Patients must not have worsening of neurologic function, according to assessment by investigator, within 3 weeks prior to first dose of 131I-burtomab.
    4. Patients must not have an uncontrolled life-threatening infection.
    5. Patients must not have received cranial or spinal irradiation less than 3 weeks prior to first dose of 131I-burtomab in this trial
    6. Patients must not have received systemic chemo/ immunotherapy (corticosteroids not included) less than 3 weeks prior to enrolment in this trial.
    7. Patients must not have received any B7-H3 treatment prior to enrolment in this trial.
    8. Patients must not have severe major non-hematologic organ toxicity; specifically, any renal, cardiac, hepatic, pulmonary, and gastrointestinal system toxicity must fall below Grade 3 prior to enrolment in this trial. Patients with stable neurological deficits (due to brain tumor) are not excluded. Patients with Grade 3 or lower hearing loss are not excluded.
    9. Patients must not be pregnant or breast-feeding
    10. A woman of child-bearing potential who does not agree to use adequate contraception during treatment and for a period of 40 days after the last 131I-burtomab dose: intrauterine devices or hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices, or injections with prolonged release). A sterilized or infertile woman is exempt from the requirement to use contraception after 131I-burtomab treatment: she must have undergone surgical sterilization (hysterectomy, or bilateral ovariectomy).
    1. Pacientes con Neuroblastoma Primario (NB) en el SNC
    2. Los pacientes no deben tener hidrocefalia comunicante obstructiva o sintomática.
    3. Los pacientes no deben tener un empeoramiento de la función neurológica según la valuación del investigador, dentro de 3 semanas previas a la primera dosis de 131I-burtomab
    4. Los pacientes no deben tener una infección no controlada potencialmente mortal.
    5. Los pacientes no deben haber recibido irradiación craneal o espinal en las 3 semanas antes de la primera dosis de 131I burtomab del ensayo.
    6. Los pacientes no deben haber recibido quimio/inmuno terapia sistémica (corticosteroides no incluidos) en las 3 semanas antes de la inclusión en el ensayo.
    7. Los pacientes no deben haber recibido ningún tratamiento anti-B7-H3 antes de la inclusión en el ensayo.
    8. Los pacientes no deben tener toxicidad grave en ningún órgano principal no hematológico; concretamente, cualquier toxicidad del sistema renal, cardíaco, hepático, pulmonar y gastrointestinal debe ser menor de Grado 3 antes de la inclusión en el ensayo. No se excluyen los pacientes con déficit neurológico estable (debido a un tumor cerebral). Pacientes con pérdida auditiva de Grado 3 o inferior no se excluyen.
    9. Las pacientes no deben estar embarazadas o lactando
    10. Se excluye las mujeres en edad fértil que no consiente en usar un método anticonceptivo adecuado hasta 40 días después de la última dosis de 131I-burtomab: dispositivos intrauterinos o anticonceptivos hormonales (píldoras orales anticonceptivas, implantes, parches transdérmicos, anillos vaginales o inyecciones de acción prolongada). Una mujer esterilizada o infértil está exenta de la obligación de utilizar un método anticonceptivo después el tratamiento con 131I-burtomab: debe haber sido sometidas a esterilización quirúrgica (histerectomía o la ovariectomía bilateral).
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival (OS) rate at 3 years after the first treatment dose of 131I-burtomab
    Supervivencia Global (SG) a 3 años tras de la primera dosis de 131I burtomab
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 3 years after 131I-burtomab treatment
    Hasta 3 años después del tratamiento con 131I-burtomab
    E.5.2Secondary end point(s)
    1. ORR (objective response rate) is defined and assessed as a combination of partial response and complete response as defined by the Revised Assessment in Neuro-Oncology (RANO) criteria and CSF cytology.
    2. ORR according to CSF cytology. ORR is defined and assessed as a combination of partial response and complete response.
    3. CNS PFS (progression free survival) will be assessed at 6 months after the first treatment dose of 131I-burtomab by comparing baseline radiological scans by MRI to radiological scans conducted 26 weeks after 131I-burtomab treatment.
    4. Dosimetry by nuclear imaging and CSF and blood sampling: Spinal cord, brain and ROI absorbed radiation doses will be estimated and CSF mean absorbed radiation doses will be calculated on the basis of nuclear imaging scans (SPECT) taken at 4, 24 and 48 h post injection of the dosimetry dose of 2mCi and treatment dose of 50 mCi . Additionally, the mean absorbed radiation dose in CSF and blood will be calculated from CSF and blood radioactivity measured in CSF and blood samples taken after the dosimetry and the treatment doses .
    5. Pharmacokinetic analysis in blood and CSF including Cmax, elimination half-life as well as the areas under the radioactivity vs. time curves .
    6. The frequency, type, and duration of treatment-emergent severe adverse events and serious adverse events, including clinically significant laboratory abnormalities. All adverse events will be graded according to CTCAE, version 4.0.
    7. Performance assessment to monitor gross changes in neurological function is performed at week 26 and subsequently every 6 months during trial period
    1. La ORR (tasa de respuesta objetiva) se define y evalúa como una combinación de respuesta parcial y respuesta completa definidas según los criterios de la Evaluación en Neuro-Oncología Revisada (RANO) y de citología del LCR.
    2. La ORR según citología del LCR. La ORR se define y evalúa como una combinación de respuesta parcial y respuesta completa.
    3. La SLP (supervivencia libre de progresión) de Neuroblastoma en el SNC se evaluará a los 6 meses después de la primera dosis de131I-burtomab mediante la comparación de las imágenes de RM basales con las imágenes obtenidas 26 semanas después del tratamiento con 131I-burtomab.
    4. La dosimetría será evaluada mediante imágenes nucleares, LCR y muestras de sangre: se estimarán las dosis de radiación absorbida en la médula espinal, cerebro y ROI y las dosis media de radiación absorbida en el LCR se calcularán a partir de imágenes nucleares (SPECT) tomadas a las 4, 24 y 48 h después de la inyección de la dosis de dosimetría de 2 mCi y de la dosis de tratamiento de 50 mCi. Además, la dosis media de radiación absorbida en el LCR y sangre se calculará a partir de la radioactividad mesurada en el LCR y muestras de sangre tomadas después de la dosis de dosimetría y de tratamiento.
    5. Análisis farmacocinética en sangre y LCR incluyendo Cmax, vida media de eliminación así como las áreas bajo la radioactividad vs. curva del tiempo.
    6. Frecuencia, tipo y duración de los acontecimientos adversos severos y acontecimientos adversos graves ocurridos durante el tratamiento, incluidas las anormalidades clínicamente significativas de laboratorio. Todos los acontecimientos adversos será clasificados según los CTCAE, versión 4.0
    7. La evaluación del rendimiento para controlar las variaciones totales en la función neurológica se realiza en la semana 26 y posteriormente cada 6 meses durante el ensayo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Short-term follow-up at 26 weeks after the first therapeutic dose of 131I-burtomab and with long-term follow-up for up to 3 years after the first treatment dose of 131I-burtomab
    Seguimiento a corto plazo a las 26 semanas después la primera dosis terapéutica de 131I-burtomab y con seguimiento a largo plazo de hasta 3 años después de la primera dosis de 131I-burtomab
    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 Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    dosimetry
    dosimetría
    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) 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 EEA3
    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
    Denmark
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    End of trial (EOT) will occur when all patients have been followed until the long-term follow-up visit at 3 years, or death whichever comes first
    La Fin del Ensayo (EOT) se tendrá cuando todos los pacientes hayan sido seguidos hasta la visita de seguimiento de largo plazo a los 3 años o la muerte, lo que ocurra primero
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 32
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 1
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 12
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 17
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 2
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients could be between the ages of birth and 18 years and therefore informed consent from legal guardian(s) and/or child must be obtained in accordance with local regulation. Pediatric patients must provide assent as required by local regulations
    Los pacientes pueden tener entre 0 y 18 años y por lo tanto el consentimiento informado de tutor(es) legal(es) y/o niños debe seguir las normativas locales . Los pacientes pediátricos deben dar su consentimiento según lo exigen las normativas locales
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 32
    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)
    Any treatment deemed safe and justified by the investigator can be administered according to clinical practice and at the discretion of the investigator
    Cualquier tratamiento que se considere seguro y justificado puede administrarse de acuerdo con la práctica clínica y a discreción del investigador
    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 Decision2018-04-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-06-02
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