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    Summary
    EudraCT Number:2020-003958-67
    Sponsor's Protocol Code Number:CAAA405A12302
    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:2021-08-20
    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 number2020-003958-67
    A.3Full title of the trial
    Phase II/III study for evaluation of the diagnostic performance of [18F]CTT1057 PET imaging for the detection of PSMA positive tumors using histopathology as a standard of truth (GuideView)
    Estudio de fase II/III para evaluar la capacidad diagnóstica de la PET
    con [18F]CTT1057 en la detección de tumores PSMA positivo
    considerando la histopatología como estándar de referencia
    (GuideView).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Diagnostic performance of [18F]CTT1057 PET versus pathology
    Capacidad diagnóstica del PET con el fármaco [18F]CTT1057 en comparación con anatomía patológica
    A.3.2Name or abbreviated title of the trial where available
    GuideView
    GuideView
    A.4.1Sponsor's protocol code numberCAAA405A12302
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovartis Farmacéutica, S.A.
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNovartis Pharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farmacéutica, S.A.
    B.5.2Functional name of contact pointTrial Monitoring Organization (TMo)
    B.5.3 Address:
    B.5.3.1Street AddressGran Vía de les Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number+34 90 0353036
    B.5.6E-maileecc.novartis@novartis.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation 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 name[18F]CTT1057
    D.3.2Product code AAA405
    D.3.4Pharmaceutical form Solution for injection
    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 INNnot yet available
    D.3.9.2Current sponsor codeAAA405
    D.3.9.4EV Substance CodeSUB221208
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/ml megabecquerel(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number370
    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 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
    Untreated high risk prostate cancer
    Cáncer de próstata de alto riesgo no tratado
    E.1.1.1Medical condition in easily understood language
    Prostate cancer
    Cáncer de próstata
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10036918
    E.1.2Term Prostate cancer stage II
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The co-primary objectives of this study are
    • to evaluate the patient-level sensitivity of [18F]CTT1057 [evaluated for all patients]
    • to evaluate the region-level specificity of [18F]CTT1057 [evaluated for all regions]
    Los co/objetivos principales de este estudio son:
    -Evaluar la sensibilidad de [18F]CTT1057 a nivel paciente.
    -Evaluar la especificidad de [18F]CTT1057 a nivel región
    E.2.2Secondary objectives of the trial
    • Evaluate the patient-level specificity of [18F]CTT1057 [evaluated for all patients]
    • Evaluate the patient-level positive predictive value of [18F]CTT1057
    • Evaluate the patient-level negative predictive value of [18F]CTT1057
    • Evaluate the patient-level accuracy of [18F]CTT1057 [evaluated for all patients]
    • Evaluate the region-level sensitivity of [18F]CTT1057 for patients excluding micro-metastasis
    • Evaluate the region-level sensitivity of [18F]CTT1057
    • Evaluate the region-level positive predictive value of [18F]CTT1057
    • Evaluate the region-level negative predictive value of [18F]CTT1057
    • Evaluate the region-level accuracy of [18F]CTT1057 evaluated for all regions
    • Detection of distant metastasis in PS patients evaluated for all regions
    • Characterize the safety and tolerability of [18F]CTT1057
    • [18F]CTT1057 scan inter-reader variability
    • [18F]CTT1057 scan intra-reader variability

    other protocol-defined secondary objectives may apply.
    -Evaluar la especificidad de [18F]CTT1057 a nivel paciente
    -Evaluar el valor predictivo positivo de [18F]CTT1057 a nivel paciente
    -Evaluar el valor predictivo negativo de [18F]CTT1057 a nivel paciente
    -Evaluar la precisión de [18F]CTT1057 a nivel paciente
    -Evaluar la sensibilidad de [18F]CTT1057 a nivel región en los
    pacientes, excluyendo las micrometástasis
    -Evaluar la sensibilidad de [18F]CTT1057 a nivel región anatómica
    -Evaluar el valor positivo de[18F]CTT1057 a nivel región anatómica
    -Evaluar el valor predictivo negativo de [18F]CTT1057 a nivel región
    anatómica
    -Evaluar la precisión a nivel región de [18F]CTT1057 evaluada en
    todas las regiones anatómicas
    Detección de metástasis distante en pacientes con estadificación
    primaria(EP)evaluados en todas las regiones anatómicas
    -Caracterizar la seguridad y la tolerabilidad de [18F]CTT1057
    -Variabilidad interintérprete de la imagen con [18F]CTT1057
    Otros objetivos secundarios definidos en el protocolo podríann aplicar
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Untreated high risk biopsy-proven PCa patients according to D’Amico classification (Stage T2c or PSA level >20ng/ml or Gleason score ≥8)
    2. Scheduled or planned radical prostatectomy and extended pelvic lymph node resection up to 6 weeks after the investigational PET/CT scan followed by histopathology assessment
    3. ECOG performance status 0-2
    4. Signed informed consent must be obtained prior to participation in the study
    5. Participants must be adults ≥ 18 years of age
    1. Pacientes con CP de alto riesgo confirmado por biopsia y no
    tratado según la clasificación de D’Amico (estadio T2c o nivel de antígeno prostático específico [PSA] >20 ng/ml o puntuación de Gleason >/=8).
    2.Prostatectomía radical y resección ampliada de los ganglios linfáticos pélvicos programadas o previstas hasta 6 semanas después del PET/TC con el fármaco en investigación seguidas de una evaluación histopatológica.
    3. Estado funcional del Grupo Cooperativo Oncológico del Este (ECOG) de 0-2.
    4. Se deberá obtener el consentimiento informado firmado antes de la participación en el estudio.
    5. Los participantes deben ser adultos >/=18 años de edad.
    E.4Principal exclusion criteria
    1. Inability to complete the needed investigational and standard-of-care imaging examinations due to any reason (severe claustrophobia, inability to lie still for the entire imaging time, etc.)
    2. Any additional medical condition, serious intercurrent illness, concomitant cancer or other extenuating circumstance that, in the opinion of the Investigator, would indicate a significant risk to safety or impair study participation, including, but not limited to, current severe urinary incontinence, hydronephrosis, severe voiding dysfunction, need of indwelling/condom catheters, New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, active hepatitis B or C, and COVID-19.
    3. Known allergy, hypersensitivity, or intolerance to [18F]CTT1057
    4. Prior and current use of PSMA targeted therapies
    5. Prior and current treatment with LHRH analogues
    6. Any prior ADT (first or second generation) within 9 months before screening
    7. Any 5-alpha reductase inhibitors within 30 days before screening
    8. Patients with small cell or neuroendocrine PCa in more than 50% of biopsy tissue
    9. Patients with incidental PCa after transuretheral resection
    10. Use of other investigational drugs within 30 days before screening
    1. Incapacidad para someterse a las exploraciones con imágenes en investigación y de referencia necesarias por cualquier motivo (claustrofobia grave, incapacidad para permanecer tumbado sin moverse durante el tiempo que dure el proceso, etc.).
    2. Cualquier otra enfermedad, enfermedad intercurrente grave, cáncer concomitante u otra circunstancia atenuante que, según el
    investigador, implicaría un riesgo significativo para la seguridad o afectaría a la participación en el estudio, incluyendo, entre otras, incontinencia urinaria grave actual, hidronefrosis, disfunción de vaciado grave, necesidad de catéteres implantados/tipo condón,
    insuficiencia cardíaca congestiva de clase III o IV según la Asociación de Cardiología de Nueva York (NYHA), antecedentes
    de síndrome del segmento QT largo congénito, infección no controlada, hepatitis B o C activa y enfermedad por coronavirus 2019 (COVID-19).
    3. Alergia, hipersensibilidad o intolerancia conocidas a [18F]CTT1057.
    4. Uso anterior y actual de tratamientos dirigidas a PSMA.
    5. Tratamiento anterior y actual con análogos de la hormona liberadora de la hormona luteinizante (LHRH).
    6. Cualquier terapia de deprivación de andrógenos (TDA) anterior
    (primera o segunda generación) durante los 9 meses anteriores a la selección.
    7. Cualquier inhibidor de la 5-alfa-reductasa durante los 30 días anteriores a la selección.
    8. Pacientes con CP de células pequeñas o neuroendocrino en más del 50 % del tejido de la biopsia.
    9. Pacientes con CP secundario después de una resección transuretral.
    10 Uso de otros fármacos en investigación durante los 30 días anteriores a la selección.
    E.5 End points
    E.5.1Primary end point(s)
    • Sensitivity of [18F]CTT1057 PET imaging, considering PSMA positive patients those who show at least one pathological [18F]CTT1057 uptake either in the primary tumor and/or metastatic pelvic lymph nodes (PLN) regions, with anatomically localized correspondence with the SoT.

    • Specificity of [18F]CTT1057 PET imaging, defined as proportion of regions that test negative for lymph nodes on [18F]CTT1057 among those that are lymph node negative on the SoT.
    -Sensibilidad de imagen del PET con [18F]CTT1057, considerando pacientes con PSMA positivo aquellos que muestran al menos una captación patológica de [18F]CTT1057 en el tumor primario y/o en los ganglios linfáticos pélvicos metastásicos con correspondencia localizada anatómicamente con el estándar de referencia.

    -Especificidad de imagen del PET con [18F]CTT1057, definido como la proporción de regiones anatómicas con resultado negativo en los ganglios linfáticos con [18F]CTT1057 y aquellos que son ganglios linfáticos negativos con el estándar de referencia.
    E.5.1.1Timepoint(s) of evaluation of this end point
    For both co-primary endpoints [18F]CTT1057 PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from [18F]CTT1057 scan.
    Para ambas variables principales, la imagen del PET con [18F]CTT1057 realizada en el día 1 se evaluó en función de la histopatología como estándar de referencia obtenida durante la cirugía dentro de las 6 semanas desde la realización de la exploración con [18F]CTT1057.
    E.5.2Secondary end point(s)
    • Specificity of [18F]CTT1057 PET imaging, considering PSMA negative patients those who do not show any pathological [18F]CTT1057 uptake either in the primary tumor or metastatic lymph nodes and will be confirmed not having primary tumor or metastatic lymph nodes with the SoT
    • Proportion of patients who are both [18F]CTT1057 and SoT positive (true positives (TP) among those who test positive on [18F]CTT1057 (TP+ false positives(FP))
    • Proportion of patients who are both [18F]CTT1057 and SoT negative (true negatives (TN)) among those who test negative on [18F]CTT1057 (TN+ false negatives (FN))
    • Proportion of patients that are SoT and [18F]CTT1057 positive (TP) and negative (TN) among all patients enrolled (TP+TN+FP+FN)
    • Sensitivity of [18F]CTT1057 PET imaging in the PLN region, excluding from the analysis those lymph nodes showing metastasis <2mm (micro-metastasis)
    • Proportion of PLN regions that test positive on both [18F]CTT1057 and SoT (TP) among those that are SoT positive (TP+FN)
    • Proportion of PLN regions that are SoT and [18F]CTT1057 positive (TP) among those regions that test positive on [18F]CTT1057 (TP+FP)
    • Proportion of PLN regions that are SoT and [18F]CTT1057 negative (TN) among those regions that test negative on [18F]CTT1057 (TN+FN)
    • Proportion of PLN regions that are SoT and [18F]CTT1057 positive (TP) and negative (TN) among all PLN regions assessed [18F]CTT1057 (TP+TN+FP+FN)
    • Number of distant metastasis identified at PET/CT scan in all patients, and percentage of patients with at least one lesion outside the prostate (primary tumor) identified by PET/CT scan
    • Incidence of AEs after PET tracer injection, after PET/CT scan and at 24-72 h after PET/CT scan. Treatment emergent adverse event (TEAE) rate within 14 days of administration
    • Inter-reader agreement of [18F]CTT1057 images
    • Intra-reader agreement of [18F]CTT1057 images
    • Summary statistics of [18F]CTT1057 pharmacokinetic parameters (i.e. Cmax, Tmax, AUClast, AUCinf, T1/2, Vz and CL from blood radioactivity data; quantification of urinary excretion of [18F]CTT1057 from urine data)
    -Especificidad del PET con [18F]CTT1057, considerando pacientes con PSMA negativo aquellos que no muestran ninguna captación patológica de [18F]CTT1057 en el tumor primario o ganglios linfáticos metastásicos y que se confirmará que no tiene tumor primario o ganglios linfáticos metastásicos con el estándar de referencia.
    -Proporción de pacientes que son positivos a la captación de [18F]CTT1057 y al estándar de referencia (verdaderos positivos (TP) entre aquellos que dan positivo a [18F]CTT1057 (TP+ falsos positivos (FP)).
    -Proporción de pacientes que son negativos a la captación de [18F]CTT1057 y al estándar de referencia frente aquellos que dan negativo a [18F]CTT1057 (TN+falsos negativos (FN))
    -Proporción de pacientes que son positivos y negativos a [18F]CTT1057 y al estándar de referencia frente a todos los pacientes incluidos (TP+TN+FP+FN)
    -Sensibilidad de la imagen por PET con [18F]CTT1057 en la región de nódulos linfáticos pélvicos, excluyendo del análisis aquellos ganglios linfáticos que muestren metástasis < 2mm (micro-metástasis)
    -Proporción de regiones de ganglios linfáticos pélvicos que dan positivo a [18F]CTT1057 y al estándar de referencia entre aquellos que son positivos al estándar de referencia (TP+FN).
    -Proporción de regiones de ganglios linfáticos pélvicos que dan positivo a [18F]CTT1057 y al estándar de referencia entre aquellas regiones anatómicas que son positivos a [18F]CTT1057 (TP+FP).
    -Proporción de regiones de ganglios linfáticos pélvicos que dan negativo a [18F]CTT1057 y al estándar de referencia entre aquellas regiones anatómicas que son negativos a [18F]CTT1057 (TN+FN).
    -Proporción de regiones de ganglios linfáticos pélvicos que den positivo a [18F]CTT1057 y al estándar de referencia entre todas las regiones anatómicas de ganglios linfáticos pélvicos evaluadas con [18F]CTT1057 (TP+TN+FP+FN).
    -Número de metástasis distantes identificadas con la exploración PET/TAC en todos los pacientes, y porcentaje de pacientes con al menos una lesión fuera de la próstata (tumor primario) identificado por exploración PET/TAC.
    -Incidencia de Eventos adversos (AE) después de la inyección del trazador, después de la exploración con PET/TAC y tras 24-72 horas de la exploración con PET/TAC. Tasa de eventos adversos emergentes del tratamiento dentro de los 14 días posteriores a la administración.
    -Acuerdo interintérprete de las imágenes con [18F]CTT1057
    -Acuerdo intraintérprete de las imágenes con [18F]CTT1057
    -Resumen estadístico de los parámetros farmacocinéticos de [18F]CTT1057 (por ejemplo: Cmax, Tmax, AUClast, AUCinf, T1/2, Vz y CL a partir de datos de radioactividad en sangre; cuantificación de la excreción urinaria de [18F]CTT1057 a partir de los datos urinarios.
    E.5.2.1Timepoint(s) of evaluation of this end point
    For majority of secondary endpoints [18F]CTT1057 PET imaging acquired at Day 1 assessed against histopathology as Standard of Truth (SoT) obtained during surgery within 6 weeks from [18F]CTT1057 scan.

    PK blood and urine collection will be performed at Day 1 at various scheduled timepoints.

    Safety endpoints will be collected from up to 28 days prior study medication administration to 14 days after study medication administration.
    Para la mayoría de las variables secundarias de las imágenes de PET con [18F]CTT1057 obtenidas en el día 1 se evaluaron con la histopatología como estándar de referencia (SoT) obtenida durante la cirugía dentro de las 6 semanas desde la exploración con [18F]CTT1057
    Obtención de muestra de sangre y orina para PK será realizada en el día 1 en diferentes momentos programados.
    Las variables de seguridad serán recogidas desde 28 días antes de la administración de la medicación del estudio hasta 14 días después de la administración de estudio.
    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 Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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
    Tolerability
    Tolerabilidad
    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 Yes
    E.8.1.7.1Other trial design description
    multi-center, single-arm, open-label prospective study
    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.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    United States
    France
    Italy
    Spain
    Switzerland
    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
    Study completion is defined as when the last participant finishes the last visit for the study or, in the event of an early study termination decision, the date of that decision.
    La finalización del estudio tendrá lugar cuando el último participante finalice la última visita del estudio o, en el caso de que haya una decisión de terminación anticipada del estudio, la fecha de esa decisión.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days5
    E.8.9.2In all countries concerned by the trial years2
    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: 58
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 137
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state43
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 133
    F.4.2.2In the whole clinical trial 195
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-08-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-28
    P. End of Trial
    P.End of Trial StatusOngoing
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