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    Summary
    EudraCT Number:2010-019181-91
    Sponsor's Protocol Code Number:EAURF2008-01
    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:2018-05-21
    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 number2010-019181-91
    A.3Full title of the trial
    Treatment of High Grade Non-Muscle Invasive Urothelial Carcinoma of the Bladder by Standard Number and Dose of Intravesical BCG Instillations Versus Reduced Number of Intravesical Instillations with Standard Dose of BCG.
    A European Association of Urology Research Foundation Randomised Phase III Clinical Trial.
    Tratamiento del carcinoma urotelial no vesical de alto grado de vejiga mediante el número estándar y la dosis de instilaciones de BCG intravesical frente al número reducido de instilaciones intravesicales con dosis estándar de BCG.
    Un ensayo clínico aleatorizado de fase III de la Asociación Europea de Investigación de Urología
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Standard number and dose intravesical instillation therapy with BCG versus Reduced number and standard dose intravesical instillation therapy with BCG in patients with high grade non-muscle invasive urinary bladder carcinoma.
    Número estándar y dosis de terapia de instilación intravesical con BCG versus terapia de instilación intravesical de dosis reducida y dosis estándar con BCG en pacientes con carcinoma de vejiga urinaria no músculo invasivo de alto grado.
    A.3.2Name or abbreviated title of the trial where available
    Standard vs Reduced Frequency BCG instillation therapy
    Terapia de instilación BCG estándar versus terapia de frecuencia reducida
    A.4.1Sponsor's protocol code numberEAURF2008-01
    A.5.4Other Identifiers
    Name:Arbeitsgemeinschaft für Urologische OnkologieNumber:AB37/10
    Name:Nederlands Trial RegisterNumber:NTR4011
    Name:Deutsches Register Klinischer StudienNumber:DRKS00005651
    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 SponsorEAU Foundation for Urological Research
    B.1.3.4CountryNetherlands
    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 supportEAU Foundation for Urological Research
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportDeutsche Krebshilfe
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEAU Foundation for Urological Research
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street AddressMr. E.N. van Kleffensstraat 5
    B.5.3.2Town/ cityArnhem
    B.5.3.3Post code6842 CV
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31263890677
    B.5.5Fax number+31263890679
    B.5.6E-mailresearchfoundation@uroweb.org
    D. IMP Identification
    D.IMP: 1
    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 OncoTICE
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme de España, S.A
    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.3.4Pharmaceutical form Intravesical solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravesical use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBCG
    D.3.9.3Other descriptive nameBACILLUS CALMETTE-GUÉRIN (BCG), TICE
    D.3.9.4EV Substance CodeSUB25779
    D.3.10 Strength
    D.3.10.1Concentration unit billion CFU billion colony forming units
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.2 to 0.8
    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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name OncoTICE. The IMP used in de (test) study arm is the same as the (comparator) standard arm but used in reduced frequency.
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme de España, S.A
    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.3.4Pharmaceutical form Intravesical solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravesical use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBCG
    D.3.9.3Other descriptive nameBACILLUS CALMETTE-GUÉRIN (BCG), TICE
    D.3.9.4EV Substance CodeSUB25779
    D.3.10 Strength
    D.3.10.1Concentration unit billion CFU billion colony forming units
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.2 to 0.8
    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) Yes
    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
    Non muscle invasive bladder cancer after transurethral resection of the Bladder Tumor (TURT).
    Cáncer de vejiga no músculo invasivo después de la resección transuretral del tumor de vejiga (TURT)
    E.1.1.1Medical condition in easily understood language
    Non muscle invasive bladder cancer after transurethral resection of the Bladder Tumor (TURT).
    Cáncer de vejiga no músculo invasivo después de la resección transuretral del tumor de vejiga (TURT).
    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 10005003
    E.1.2Term Bladder cancer
    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
    The primary objective of this study is to identify if reduced number of BCG instillations are not inferior to standard number and dose intravesical BCG treatment in patients with high grade NMIBC. The primary endpoint for inferiority analysis is time to first recurrence.
    El objetivo principal de este estudio es identificar si el número reducido de instilaciones de BCG no es inferior al número estándar y el tratamiento con BCG intravesical a dosis en pacientes con NMIBC de alto grado. La variable principal para el análisis de inferioridad es el tiempo hasta la primera recurrencia.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to identify if number and grade of recurrent tumors, rate of progression to a higher stage (T2 or higher) of the disease and safety, specifically the presence of treatment related toxicity > grade 2 differ between the two study arms.
    Los objetivos secundarios son identificar si el número y el grado de tumores recurrentes, la tasa de progresión a un estadio superior (T2 o superior) de la enfermedad y la seguridad, específicamente la presencia de toxicidad relacionada con el tratamiento> grado 2 difiere entre los dos brazos de estudio.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    (1) Prospective evaluation of urinary cytokine levels in patients treated with reduced number of BCG intravesical instillations compared to standard BCG treatment.
    Urine samples will be collected prior to and between 4 and 8 hr after each instillation both during the induction and maintenance period. Levels of IL-2, IL-4, IL10 and IFN-gamma will be determined in urine with commercially available, enzyme-linked immunosorbent assays.
    (2) Validation of predictive genetic markers for BCG response.
    From blood samples of trial participants who gave their informed consent for this substudy DNA will be isolated.
    Single-SNP Centaurus assays (or a custom made chip) will be used to genotype genetic polymorphisms. SNP genotypes will be tested for association with recurrence- and progression-free survival after BCG treatment among the overall group of trial participants.
    (1) Evaluación prospectiva de los niveles de citocina en orina en pacientes tratados con un número reducido de instilaciones intravesicales de BCG en comparación con el tratamiento estándar con BCG.
    Las muestras de orina se recogerán antes y entre 4 y 8 horas después de cada instilación, tanto durante el período de inducción como de mantenimiento. Los niveles de IL-2, IL-4, IL10 e IFN-gamma se determinarán en la orina con ensayos inmunoabsorbentes ligados a enzimas disponibles en el mercado.
    (2) Validación de marcadores genéticos predictivos para la respuesta de BCG.
    A partir de las muestras de sangre de los participantes del ensayo que dieron su consentimiento informado para este subestudio, se aislará el ADN.
    Los ensayos Single-SNP Centaurus (o un chip hecho a medida) se usarán para genotipar polimorfismos genéticos. Los genotipos de SNP se probarán para la asociación con la supervivencia libre de recurrencia y progresión después del tratamiento con BCG entre el grupo general de participantes en el ensayo.
    E.3Principal inclusion criteria
    1. Presence of high grade (Ta-T1) urothelial papillary carcinoma of the bladder with or without CIS
    1.1. Tumors can be primary or recurrent
    1.2. Tumors can be single or multiple
    2a. In case of a Ta high grade tumor in the initial resection, a re-TUR can be performed at the discretion of the investigator. Initial resection or re-TUR must include the deep resection or cold cup biopsy (deep enough to obtain muscle tissue) of the (initial) tumor site(s)
    2b. In case of a T1 high grade tumor in the initial resection, a re-TUR should be performed at weeks 4-8 after initial resection, which must include the deep resection or cold cup biopsy (deep enough to obtain muscle tissue) of the initial tumor site(s)
    3. Re-re-TUR should be performed at weeks 4-8 after re-TUR in case of histological detection of T1 low/high grade tumor in the re-TUR, which must include the deep resection or cold cup biopsy (deep enough to obtain muscle tissue) of the initial tumor site(s)
    4. Histopathologically confirmed absence of T1 low/high grade tumor(s) in the re-TUR specimen and/or re-re-TUR specimen
    5. All visible papillary tumors must be completely resected
    6. If the patient is male, he must use a condom during sexual intercourse during the first week after BCG treatment. If the patient is female, and of childbearing potential, she must practice adequate contraception for 30 days prior to administration of study treatment, have a negative pregnancy test and continue such precautions during all study treatment period and for 3 months after the last BCG treatment.
    7. Signed and dated informed consent form
    8. Patient is clinically fit enough to receive BCG bladder instillations.
    1. Presencia de carcinoma urotelial papilar de vejiga de alto grado (Ta-T1) con o sin CIS
    1.1. Los tumores pueden ser primarios o recidiva
    1.2. Los tumores pueden ser sencillos o múltiples
    2a. En el caso de un tumor de alto grado Ta en la resección inicial, se puede realizar una re-RTU a
    discreción del investigador. Resección inicial o re-TUR debe incluir la resección profunda o la biopsia de cono frío (lo suficientemente profunda como para obtener tejido múscular) del tumor (inicial) local (es).
    2b. En el caso de un tumor de alto grado T1 en la resección inicial, una re-RTU se debería realizar en las
    semanas 4-8 después de la resección inicial, que debe incluir la profunda resección o biopsia de cono frío (lo suficientemente profunda para obtener tejido muscular) del tumor inicial (es) local (es).
    3. Re-re-TUR se debe realizar en las semanas 4-8 después de la re-RTU en caso de detección histológica de tumor de grado bajo / alto T1 en la re-RTU, que debe incluir la resección profunda o la biopsia de cono frío (lo suficientemente profunda como para obtener tejido múscular del tumor inicial (es) local (es).
    4. Ausencia confirmada histopatológicamente de T1 tumor (es) de bajo / alto grado en la muestra de re-RTU y/o en la muestra de re-re-RTU.
    5. Todos los tumores papilares visibles deben estar extirpados completamente.
    6. Si el paciente es hombre, debe usar un condón durante las relaciones sexuales durante la primera semana después del tratamiento con BCG. Si el paciente es mujer, y de potencialmente fértil, debe usar adecuados métodos anticonceptivos durante 30 días antes de la administración del tratamiento del estudio, tener una prueba de embarazo negativa y continuar dichas precauciones durante todo el período de tratamiento del estudio y durante los 3 meses después del último tratamiento con BCG
    7. Formulario de consentimiento informado firmado y fechado.
    8. Los pacientes están clínicamente apto para recibir instilaciones de BCG en la vejiga.
    E.4Principal exclusion criteria
    . Any previous intravesical BCG therapy
    2. Presence of primary CIS only
    3. Presence of histopathologically proven muscle invasive urothelial carcinoma of the bladder at first or re-TUR surgical specimens
    4. Presence of any tumors in upper urinary tract or in the prostatic urethra at any time
    5. Presence of any other histological type of resected tumor other than urothelial carcinoma on the first or second resection
    6. Presence of another malignancy within 5 years except for basal cell carcinoma of the skin or localised prostate cancer in active surveillance
    7. Presence of pregnancy or lactation
    8. Presence of active tuberculosis, any form of immunodeficiency (eg HIV + serology, transplant recipients) and/or any other contraindication of BCG therapy
    9. Patients who have received any systemic cytostatic agents or multi-installation intravesical chemotherapy in the last 3 months prior to randomisation. Early postoperative (within 6 hours of resection) single dose chemotherapy is allowed after the first resection. However, it should not be given after (re-)re-TUR if the patient is considered eligible for this study
    10. Patients with uncontrollable UTI
    1. Cualquier terapia previa intravesical de BCG
    2. Presencia de CIS primario.
    3. Presencia de carcinoma urotelial invasivo a la capa muscular probado histopatológicamente en la muestra de la primera o en la re-RTU.
    4. Presencia de cualquier tumor en el tracto urinario superior o en la uretra prostática en cualquier
    momento.
    5. Presencia de cualquier otro tipo histológico de tumor extirpado a parte del carcinoma urotelial en la primera o segunda resección.
    6. Presencia de otra malignidad en los 5 años anteriores a la aleatorización, excepto para el carcinoma de células basales de la piel o el cáncer de próstata localizado en vigilancia activa.
    7. Presencia de embarazo o lactancia.
    8. Presencia de tuberculosis activa, cualquier forma de inmunodeficiencia (e.j.VIH+ serología, transplantes) y/o cualquier otra contraindicación de la terapia de
    BCG.
    9. Pacientes que han recibido agentes citostáticos sistémicos o multiinstilación quimioterapia intravesical en los 3 meses previos a la aleatorización. La quimioterapia de dosis única postoperatoria temprana (dentro de las 6 horas de la resección) es permitido después de la primera resección. Sin embargo, no se debe administrar después de (re) reTUR si el paciente se considera elegible para este estudio.
    10. Pacientes con UTI no controlada.
    E.5 End points
    E.5.1Primary end point(s)
    Time to first recurrence.
    Tiempo hasta la primera recurrencia
    E.5.1.1Timepoint(s) of evaluation of this end point
    Timepoint after randomisation at which the date of first recurrence of the disease occurs up to a maximum of 5 years from the first administration of BCG Vaccine for intravesical instillation.
    Tiempo después de la randomización en la cual ocurre la fecha de la primera recurrencia de la enfermedad hasta un máximo de 5 años desde la primera administración de la vacuna BCG para la instilación intravesical.
    E.5.2Secondary end point(s)
    Number and grade of recurrent tumors.
    Rate of progression to a higher stage (T2 or higher).
    Incidence and severity of side effects, specifically the presence of treatment related toxicity > Grade 2.
    Número y grado de tumores recurrentes.
    Tasa de progresión a una etapa más alta (T2 o superior).
    Incidencia y severidad de los efectos secundarios, específicamente la presencia de tratamiento relacionada con la toxicidad > Grado 2
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoint after randomisation at which the date of first recurrence of the disease occurs up to a maximum of 5 years from the first administration of BCG Vaccine for intravesical instillation.
    This timepoint will also be used for evaluation of the the secondary end points.
    Tiempo después de la randomización en que ocurre la fecha de la primera recurrencia de la enfermedad hasta un máximo de 5 años desde la primera administración de la vacuna BCG para la instilación intravesical.
    Este tiempo también se usará para la evaluación de las variables secundarias.
    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) 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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Número estándar y dosis de instilaciones de BCG
    Standard number and Dose of BCG instillations
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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 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
    Last visit of the last patient.
    La última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years9
    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: 367
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 457
    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 state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 824
    F.4.2.2In the whole clinical trial 824
    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. After recurrence, treatment will be performed according to the discretion of the treating physician.
    Ninguna. Después de la recurrencia, el tratamiento se realizará según el criterio del médico tratante.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-07-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-09-30
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