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    Summary
    EudraCT Number:2020-003959-16
    Sponsor's Protocol Code Number:CAAA405A12301
    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 number2020-003959-16
    A.3Full title of the trial
    Phase III study for evaluation of the diagnostic performance of [18F]CTT1057 PET imaging in patients with prostate cancer with rising PSA levels [biochemical recurrence (BCR)] (GuidePath)
    Estudio de fase III para evaluar la capacidad diagnóstica de PET con
    [18F]CTT1057 en pacientes con cáncer de próstata con aumento de los niveles del PSA (recurrencia bioquímica [RB]) (GuidePath).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Diagnostic performance of [18F]CTT1057 PET in BCR
    capacidad diagnóstica de [18F]CTT1057 en la RB.
    A.3.2Name or abbreviated title of the trial where available
    GuidePath
    GuidePath
    A.4.1Sponsor's protocol code numberCAAA405A12301
    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 Via de les Corts Catalanes, 764
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08013
    B.5.3.4CountrySpain
    B.5.4Telephone number34 90 0353036
    B.5.5Fax numberNA
    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 namePSMA-11 25 μg, Kit for radiopharmaceutical preparation
    D.3.2Product code AAA517
    D.3.4Pharmaceutical form Kit for radiopharmaceutical preparation
    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 INNgallium (68Ga) gozetotide
    D.3.9.2Current sponsor codeAAA517
    D.3.9.4EV Substance CodeSUB219371
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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.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 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.3.9.3Other descriptive name(2S)-2-[[[(4S)-4-carboxy-4-[[(4S)-4-carboxy-4-[6-[(4-(18F)fluoranylbenzoyl)amino]hexanoylamino]butanoyl]amino]butoxy]-hydroxyphosphoryl]amino]pentanedioic acid
    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
    Prostate cancer with rising PSA levels [biochemical recurrence (BCR)]
    cáncer de próstata con aumento de los
    niveles del PSA (recurrencia bioquímica [RB])
    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 10036911
    E.1.2Term Prostate cancer recurrent
    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 region-level correct localization rate (CLR) of [18F]CTT1057
    • to evaluate the patient-level positive predictive value (with anatomical localization) of [18F]CTT1057
    Los objetivos principales de este estudio son:
    - Evaluar la tasa de localización correcta (TLC) de [18F]CTT1057 a nivel de región anatómica.
    - Evaluar el valor predictivo positivo (con localización anatómica) de [18F]CTT1057 a nivel paciente.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are :

    • To evaluate the patient-level sensitivity of [18F]CTT1057
    • To evaluate the patient-level specificity of [18F]CTT1057
    • To evaluate the patient-level negative predictive value of [18F]CTT1057
    • To evaluate the patient-level accuracy of [18F]CTT1057
    • To evaluate the region level sensitivity of [18F]CTT1057
    • To evaluate the region level specificity of [18F]CTT1057
    • To evaluate the region level negative predictive value of [18F]CTT1057
    • To evaluate the region level accuracy of [18F]CTT1057
    • To evaluate correct detection rate (CDR)
    • To evaluate detection rate
    • To evaluate the patient-level positive predictive value related to PSA levels
    • To 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.
    Los objetivos secundarios del estudio son:
    - Evaluar la sensibilidad de [18F]CTT1057 a nivel paciente.
    - Evaluar la especificidad 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 anatómica.
    - Evaluar la especificidad de [18F]CTT1057 a nivel región anatómica.
    - Evaluar el valor predictivo negativo de [18F]CTT1057 a nivel región anatómica.
    - Evaluar la precisión de [18F]CTT1057 a nivel región anatómica.
    - Evaluar la tasa de detección correcta (TDC).
    - Evaluar la tasa de detección.
    - Evaluar el valor predictivo positivo relacionado con los niveles de PSA a nivel paciente.
    - Caracterizar la seguridad y la tolerabilidad de [18F]CTT1057.
    - Variabilidad inter-intérprete de la imagen con [18F]CTT1057.
    - Variabilidad intra-intérprete de imagen con [18F]CTT1057.

    Para mas objetivos secundarios ver protoclo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed informed consent must be obtained prior to participation in the study
    2. Biopsy proven prostate adenocarcinoma.
    3. Biochemical recurrence defined by American Urological Association (AUA) criteria for patients who have undergone radical prostatectomy (detectable or rising PSA value measured 6–13 wk after surgery, that is ≥0.2 ng/mL with a second determination of a PSA level>0.2 ng/mL at least 2 week apart) and by American Society for Radiation Oncology (ASTRO)-Phoenix criteria for patients who have undergone curative-intent radiotherapy (PSA≥2 ng/mL above the nadir).
    4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
    5. Participants must be adults ≥ 18 years of age
    1. Se deberá obtener el consentimiento informado firmado antes de la participación en el estudio.
    2. Adenocarcinoma de próstata confirmado por biopsia.
    3. Recurrencia bioquímica definida con los criterios de la Asociación Urológica Estadounidense (AUA) en pacientes que se hayan sometido a una prostatectomía radical (valor de PSA detectable o en aumento medido entre 6 y 13 semanas después de la cirugía, es decir, >/= 0,2 ng/ml con una segunda determinación de un nivel de PSA >0,2 ng/ml con una diferencia de al menos 2 semanas) y con los criterios de la Sociedad Estadounidense de Oncología Radioterápica (ASTRO)-Phoenix en pacientes que se hayan sometido a radioterapia con intención curativa (PSA >/= 2 ng/ml por encima del valor mínimo).
    4. Estado funcional del Grupo Cooperativo Oncológico del Este (ECOG) de 0-2.
    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 reasons (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 Coronavirus Disease 2019 (COVID-19)
    3. Prior major surgery undergone less than 12 weeks prior to screening (with the exception of any surgery related to prostatic cancer)
    4. Known allergy, hypersensitivity, or intolerance to [18F]CTT1057, [68Ga]Ga-PSMA-11, or to CT contrast
    5. Prior and current use of PSMA targeted therapies
    6. Prior and current treatment with Luteinizing Hormone-Releasing Hormone (LHRH) analogues
    7. Any prior ADT (first or second generation) within 9 months before screening
    8. Any 5-alpha reductase inhibitors within 30 days before screening
    9. Use of other investigational drugs within 30 days before screening
    10. Castration-resistant patients
    11. Patients with small cell or neuroendocrine PCa in more than 50% of biopsy tissue
    1. Incapacidad para someterse a las exploraciones con imágenes en investigación y de estándar 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 invalidante 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. Cirugía mayor previa realizada menos de 12 semanas antes de la selección (a excepción de cualquier cirugía relacionada con el cáncer
    de próstata).
    4. Alergia, hipersensibilidad o intolerancia conocidas a [18F]CTT1057, a [68Ga]Ga-PSMA-11 o al contraste del TC.
    5. Uso anterior y actual de tratamientos para determinar el PSMA.
    6. Tratamiento anterior y actual con análogos de la hormona liberadora de la hormona luteinizante (LHRH).
    7. Cualquier TDA anterior (primera o segunda generación) durante los 9 meses anteriores a la selección.
    8. Cualquier inhibidor de la 5-alfa-reductasa durante los 30 días anteriores a la selección.
    9. Uso de otros fármacos en investigación durante los 30 días anteriores a la selección.
    10. Pacientes con cáncer resistente a la castración.
    11. Pacientes con CP de células pequeñas o neuroendocrino en más del 50 % del tejido de la biopsia.
    E.5 End points
    E.5.1Primary end point(s)
    • Proportion of regions containing at least one TP lesion (anatomically localized correspondence between PET imaging and the reference standard), regardless of any co-existent FP findings within the same region, out of all regions containing at least one PET-positive finding by central assessments.

    • Proportion of patients who have at least one TP lesion (anatomically localized correspondence between PET imaging and the reference standard), regardless of any co-existent FP findings, out of all patients who are PET/CT scan positive by central assessments.
    - Proporción de regiones que contienen al menos una lesión verdadera positiva (VP) (correspondencia exacta entre la localización del PET y el estándar de referencia), independientemente de cualquier hallazgo falso positivo (FP) coexistente dentro de la misma región, entre todas las
    regiones que contienen al menos un hallazgo PET positivo.

    - Proporción de pacientes que presenten al menos una lesión VP (correspondencia exacta entre la localización del PET y el estándar de referencia), independientemente de cualquier hallazgo FP coexistente, entre todos los pacientes con un resultado positivo en el PET/TC.
    E.5.1.1Timepoint(s) of evaluation of this end point
    For both co-primary endpoints [18F]CTT1057 PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment)
    Para ambas variables principales, PET con [18F]CTT1057 realizada el día 1 o el día 15 y evaluada frente al estándar de referencia compuesto (CTS) realizado durante las 8 semanas (anteriores o posteriores) al PET con 18F-CTT o durante el seguimiento (hasta 90 días después de la radioterapia para la evaluación del nivel del PSA).
    E.5.2Secondary end point(s)
    • Proportion of patients that test positive on [18F]CTT1057 and CTS (TP) among those that are CTS positive (TP or FN)
    • Proportion of patients that test negative on [18F]CTT1057and CTS (TN) among those that are CTS negative (TN or FP)
    • Proportion of patients who are both [18F]CTT1057 and CTS negative (TN) among those who test negative on [18F]CTT1057 (TN or FN)
    • Proportion of patients that are CTS and [18F]CTT1057 positive (TP) and negative (TN) among those patients that identified on [18F]CTT1057 (TP, TN, FP or FN)
    • Proportion of patients who have at least one TP lesion (exactly localized correspondence between PET imaging and the reference standard), regardless of any co-existent FP findings, out of all patients who are scanned
    • Proportion of patients who have at least one PET positive lesion, regardless of TP or FP findings, out of all patients who are scanned
    • Proportion of regions that test positive on both [18F]CTT1057 and CTS (TP) among those regions that are CTS positive (TP or FN)
    • Proportion of regions that test negative on both [18F]CTT1057 and CTS (TN) among those regions that are CTS negative (FP, or TN)
    • Proportion of regions that are CTS and [18F]CTT1057 negative (TN) among those regions that test negative on [18F]CTT1057 (TN or FN)
    • Proportion of regions that are CTS and [18F]CTT1057 positive (TP) and negative (TN) among those regions that identified on [18F]CTT1057 (TP, TN, FP and FN)
    • Percentage of patients who have at least one TP lesion (exactly anatomically localized correspondence between [18F]CTT1057 PET imaging and the reference standard), regardless of any co-existent FP findings, out of all patients who are [18F]CTT1057 positive, stratified by PSA levels
    • Incidence of AEs after each PET tracer injection, after each PET/CT scan and at 24-72 h after each PET/CT scan. Treatment emergent adverse event (TEAE) rate within 14 days after each PET tracer administration
    • Inter-reader agreement of [18F]CTT1057 images
    • Intra-reader agreement of [18F]CTT1057 images
    • Concordance between [18F]CTT1057 and [68Ga]Ga-PSMA-11 for detection of positivity at patient level using central reads
    • Percentage of patients who underwent a change in intended treatment plan attributed to the PET/CT scan as assessed by pre and post imaging questionnaires
    • All the above primary and secondary endpoints independently in the subgroup of patients post-prostatectomy and the subgroup of patients after prostate radical RT
    • Proporción de pacientes con un resultado positivo al administrar [18F]CTT1057 y el CTS (VP) entre los pacientes que tienen un resultado positivo al administrar el CTS (VP o FN).
    • Proporción de pacientes con un resultado negativo al administrar [18F]CTT1057 y el CTS (VN) entre los pacientes que tienen un resultado negativo al administrar el CTS (VN o FP).
    • Proporción de pacientes con un resultado negativo tanto al administrar [18F]CTT1057 como al administrar el CTS (VN) entre los pacientes que tienen un resultado negativo al administrar [18F]CTT1057 (VN o FN).
    • Proporción de pacientes con un resultado positivo (VP) y negativo (VN) al administrar el CTS y al administrar [18F]CTT1057 entre los pacientes identificados al administrar [18F]CTT1057 (VP, VN, FP o FN).
    • Proporción de pacientes con al menos una lesión VP (correspondencia exactamente localizada entre la PET y el estándar de referencia), independientemente de cualquier hallazgo FP coexistente, entre todos los pacientes de quienes se haya obtenido imágenes.
    • Proporción de pacientes con al menos una lesión positiva en el PET, independientemente de los hallazgos VP o FP, entre todos los pacientes de quienes se haya obtenido imágenes.
    • Proporción de regiones con un resultado positivo tanto al administrar [18F]CTT1057 como al administrar el CTS (VP) entre las regiones que tienen un resultado positivo al administrar el CTS (VP o FN).
    • Proporción de regiones con un resultado negativo tanto al administrar [18F]CTT1057 como al administrar el CTS (VN) entre las regiones que tienen un resultado negativo al administrar el CTS (FP o VN).
    • Proporción de regiones con un resultado negativo al administrar el CTS y al administrar [18F]CTT1057 (VN) entre las regiones que tienen un resultado negativo al administrar [18F]CTT1057 (VN o FN).
    • Proporción de regiones con un resultado positivo (VP) y negativo (VN) al administrar el CTS y al administrar [18F]CTT1057 entre las regiones identificadas al administrar [18F]CTT1057 (VP, VN, FP y FN).
    • Porcentaje de pacientes con al menos una lesión VP (correspondencia exacta y anatómicamente localizada entre el PET con [18F]CTT1057 y el estándar de referencia), independientemente de cualquier hallazgo FP coexistente, entre todos los pacientes con un resultado positivo al administrar [18F]CTT1057, estratificados por niveles del PSA.
    • Incidencia de AA después de cada inyección con trazador para el PET, después de cada PET/TC y 24-72 horas después de cada PET/TC. Tasa de acontecimientos adversos que hayan aparecido con el tratamiento (AAAT) durante los 14 días posteriores a cada administración de trazador para el PET.
    • Acuerdo interintérprete de las imágenes con [18F]CTT1057.
    • Acuerdo intraintérprete de las imágenes con [18F]CTT1057.
    • Concordancia entre [18F]CTT1057 y [68Ga]Ga-PSMA-11 para detectar positividad con respecto al paciente mediante lecturas centrales.
    • Porcentaje de pacientes que hayan sufrido un cambio en el plan de tratamiento previsto atribuido a el PET/TC según los cuestionarios anteriores y posteriores a la obtención de las imágenes.
    • Todas las variables principales y secundarias mencionadas independientemente en el subgrupo de pacientes tras una prostatectomía y en el subgrupo de pacientes tras una radioterapia radical de próstata.
    E.5.2.1Timepoint(s) of evaluation of this end point
    For majority of secondary endpoints [18F]CTT1057 PET imaging acquired at Day 1 or Day 15 assessed against Composite Truth Standard (CTS) obtained within 8 weeks (before or after) of 18F-CTT PET scan or during follow-up (up to 90 days after radiotherapy for PSA level assessment).

    Safety endpoints will be collected from up to 28 days prior first study medication administration to 14 days after second study medication administration.
    Para la mayoría de las variables secundarias, PET con [18F]CTT1057 realizada el día 1 o el día 15 y evaluada frente al estándar de referencia compuesto (CTS) realizado durante las 8 semanas (anteriores o posteriores) a la PET con 18F-CTT o durante el seguimiento (hasta 90 días después de la radioterapia para la evaluación del nivel del PSA).
    Las variables de seguridad se recogerán desde un máximo de 28 días antes de la primera administración de la medicación del estudio hasta 14 días después de la segunda administración de la medicación del 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 No
    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) 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 Yes
    E.8.1.7.1Other trial design description
    multicéntrico, prospectivo, abierto, y de un único grupo
    prospective, open-label, multi center, single-arm 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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
    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.
    El estudio habrá finalizado cuando el último participante haya terminado la última visita del estudio, o en el caso de que se decida finalizar prematuramente el estudio, la fecha en la que se tome 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 months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    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: 57
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 133
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 125
    F.4.2.2In the whole clinical trial 190
    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 Opinion2021-04-29
    P. End of Trial
    P.End of Trial StatusOngoing
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