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    Summary
    EudraCT Number:2022-001534-11
    Sponsor's Protocol Code Number:GIT-PRo-2022-02
    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:2022-09-07
    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 number2022-001534-11
    A.3Full title of the trial
    Prophylaxis of venous thromboembolic disease with LMWH (TINzaparin) in patients with metastatic colorectal cancer who start the first line of treatment.
    Profilaxis de la enfermedad tromboembólica venosa con HBPM (TINzaparina) en pacientes con cáncer colorrectal metastásico que inician la primera línea de tratamiento.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Tinzaparin in metastatic colorectal cancer
    Tinzaparina en cáncer metastasico de colon
    A.3.2Name or abbreviated title of the trial where available
    PROTINCOL
    A.4.1Sponsor's protocol code numberGIT-PRo-2022-02
    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 SponsorGrupo Gallego de Investigación en Tumores Digestivos (GITuD)
    B.1.3.4CountrySpain
    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 supportLeo Pharma
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMFAR Clinical Research
    B.5.2Functional name of contact pointFederico Nepote
    B.5.3 Address:
    B.5.3.1Street AddressC/ Balmes 243 Esc A 5º 1ª
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08006
    B.5.3.4CountrySpain
    B.5.4Telephone number003493 434 44 12
    B.5.6E-mailinvestigacion@mfar.net
    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 nameTinzaparin
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTinzaparin
    D.3.9.3Other descriptive nameTINZAPARIN
    D.3.9.4EV Substance CodeSUB16468MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number4500 to 8000
    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 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
    Metastatic colorectal cancer (mCRC), stage IV that initiates the first-line systemic treatment in the metastatic setting
    Cancer colorectal metastasico (CCRm), estadío IV que inician la primera línea de tratamiento sistemico en el contexto metastasico
    E.1.1.1Medical condition in easily understood language
    Metastatic colorectal cancer (mCRC)
    Cancer colorectal metastasico (CCRm)
    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 10010035
    E.1.2Term Colorectal cancer stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10052358
    E.1.2Term Colorectal cancer metastatic
    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 main objective of the study is to evaluate the efficacy of 4-months prophylaxis with LMWH (tinzaparin) for the prevention of symptomatic or incidental VTE events in patients with stage IV colorectal cancer (mCRC) that initiate first-line systemic treatment (ChT +/- targeted therapy).
    El objetivo principal del estudio es evaluar la eficacia de la profilaxis de 4 meses con HBPM (tinzaparina) para la prevención de eventos TEV sintomáticos o incidentales en pacientes con cáncer colorrectal en estadio IV (mCRC) que inician tratamiento sistémico de primera línea ( ChT +/- terapia dirigida).
    E.2.2Secondary objectives of the trial
    Efficacy:
    To evaluate the association between laterality of the primary tumor (right-sided or transversal vs. left-sided), tiangiogenic or anti EGFR treatment, resection of primary tumor, the RAS / BRAF mutational status, the geneetic risk scores and the presence of VTE.
    To evaluate cancer-specific survival outcomes in both study arms.

    Safety
    To evaluate safety of a 4-months LMWH prophylaxis in patients with stage IV colorectal cancer.
    To evaluate the association between baseline characteristics (i.e. RAS / BRAF mutations; previous surgery of the primary tumor; antiangiogenic, or anti-EGFR first-line treatments; or primary tumor laterality) and the occurrence of major bleedings and clinically relevant non-major bleedings according to ISTH criteria.
    To evaluate the association between the genetic risk scores and the occurrence of bleedings.
    Health-related quality of life (HRQoL)
    Eficacia:
    Evaluar la asociación entre la lateralidad del tumor primario (derecha o transversal vs. izquierda), el tratamiento tiangiogénico o anti EGFR, la resección del tumor primario, el estado mutacional RAS/BRAF, las puntuaciones de riesgo genético y la presencia de TEV .
    Evaluar los resultados de supervivencia específicos del cáncer en ambos brazos del estudio.

    La seguridad
    Evaluar la seguridad de una profilaxis de HBPM de 4 meses en pacientes con cáncer colorrectal en estadio IV.
    Evaluar la asociación entre las características basales (es decir, mutaciones RAS/BRAF; cirugía previa del tumor primario; tratamientos de primera línea antiangiogénicos o anti-EGFR; o lateralidad del tumor primario) y la aparición de hemorragias mayores y hemorragias no mayores clínicamente relevantes de acuerdo con los criterios de la ISTH.
    Evaluar la asociación entre los puntajes de riesgo genético y la ocurrencia de sangrados.
    Calidad de vida relacionada con la salud (CdV)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subjects with age ≥ 18 years.

    2. Written informed consent.

    3. Patients with a histologically confirmed diagnosis of stage IV colon or rectal adenocarcinoma (mCRC).

    4. Locally assessed BRAF and RAS genomic alterations available during screening.

    5. Beginning of the first line of treatment for metastatic disease with chemotherapy +/- targeted therapy (i.e. antiangiogenic, anti-EGFR, encorafenib-cetuximab doublet) or immunotherapy.

    6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

    7. Life expectancy >6 months.
    1. Sujetos masculinos o femeninos con edad ≥ 18 años.

    2. Consentimiento informado por escrito.

    3. Pacientes con un diagnóstico confirmado histológicamente de adenocarcinoma colorrectal en estadio IV (mCRC).

    4. Alteraciones genómicas BRAF y RAS evaluadas localmente disponibles durante la selección.

    5. Inicio de la primera línea de tratamiento para la enfermedad metastásica con quimioterapia +/- terapia dirigida (es decir, antiangiogénico, anti-EGFR, doblete de encorafenib-cetuximab) o inmunoterapia.

    6. Estado funcional del Grupo Oncológico Cooperativo del Este (ECOG) de 0-2.

    7. Esperanza de vida > 6 meses.
    E.4Principal exclusion criteria
    1. Contraindication to tinzaparin, or other heparins:
    a) Allergy (or hypersensitivity) to heparin, tinzaparin, other LMWHs, or pork products.
    b) History or presence of heparin-induced (type II) thrombocytopenia.
    c) Have or have had an epidural catheter or a traumatic spinal puncture within the previous 7 days.

    2. Prothrombin time (PT) (International normalized ratio [INR] >1.5 for any reason) or aPTT >2 times control value.

    3. Active major bleeding or conditions predisposing to major bleeding. a major bleeding is defined as one that meets one of the following three criteria:
    a) occurring in a critical area or organ (for example, intracranial, intra-spinal, intraocular, retroperitoneal, intra-articular or pericardial, intrauterine or intramuscular with compartment syndrome),
    b) causing a decrease in hemoglobin levels of 2 g/l (1.24 mmol/l) or more, or
    c) that requires a transfusion of two or more units of whole blood or packed red blood cells.

    4. Lesions or conditions at increased risk of clinically significant bleeding, including:
    a)Previously diagnosed/treated VTE ≤ 28 days prior to randomization.
    b) Active ulcer disease.
    c) Diagnosed cerebral metastases.
    d) Stroke within the prior 6 months.
    e) History of central nervous system (CNS) or intraocular bleeding.

    5. Requirement of other anticoagulant therapy, dual antiplatelet therapy, daily non-steroidal anti-inflammatory drugs, or other medications known to increase the risk of bleeding.
    Note: A daily dose of ≤100 mg of aspirin and single agent clopidogrel are permitted

    6. Acute or chronic renal insufficiency with Creatinine clearance < 30 ml / min.

    7. Platelet count < 80.000 /ml at the time of inclusion.

    8. Severe liver insufficiency as defined by clinical manifestations of ascites, cirrhosis, encephalopathy and/or jaundice and/or biochemical abnormalities in liver function tests including:
    a) elevated levels of total bilirubin (> 2 times the upper limit normal [ULN]),
    b) elevated liver transaminases (> 2 times the ULN; > 5 in case of hepatic metastasis).

    9. Participating in another study of an investigational agent at the time of enrollment. Note: Use of an experimental regimen of an approved product is not cause for exclusion.

    10. Patients who weigh < 50 Kg.

    11. Women of childbearing potential (WOCBP), must provide a negative serum or urine pregnancy test at screening. Women breastfeeding are not eligible.
    Note: A pregnancy test is performed on WOCBP as per standard of care for patients undergoing anticancer treatments.

    12. Any underlying medical or psychiatric disorder, which, in the opinion of the investigator, makes the administration of tinzaparin unsafe or interferes with the informed consent process or trial procedures.
    1. Contraindicación a tinzaparina u otras heparinas:
    a) Alergia (o hipersensibilidad) a heparina, tinzaparina, otras HBPM o productos derivados del cerdo.
    b) Antecedentes o presencia de trombocitopenia inducida por heparina (tipo II).
    c) Tiene o ha tenido un catéter epidural o una punción espinal traumática en los últimos 7 días.

    2. Tiempo de protrombina (PT) (índice internacional normalizado [INR] >1,5 por cualquier motivo) o aPTT >2 veces el valor de control.

    3. Sangrado mayor activo o condiciones que predisponen al sangrado mayor. Una hemorragia importante se define como aquella que cumple uno de los siguientes tres criterios:
    a) ocurre en un área u órgano crítico (por ejemplo, intracraneal, intraespinal, intraocular, retroperitoneal, intraarticular o pericárdico, intrauterino o intramuscular con síndrome compartimental),
    b) provoca una disminución de los niveles de hemoglobina de 2 g/l (1,24 mmol/l) o más, o,
    c) requiere una transfusión de dos o más unidades de sangre o concentrado de hematíes.

    4. Lesiones o afecciones con mayor riesgo de hemorragia clínicamente significativa, que incluyen:
    a) TEV previamente diagnosticada/tratada ≤ 28 días antes de la aleatorización.
    b) Enfermedad ulcerosa activa.
    c) Metástasis cerebrales diagnosticadas.
    d) Accidente cerebrovascular en los 6 meses anteriores.
    e) Antecedentes de hemorragia del sistema nervioso central (SNC) o intraocular.

    5. Requerimiento de otra terapia anticoagulante, terapia antiplaquetaria dual, medicamentos antiinflamatorios no esteroideos diarios u otros medicamentos que aumentan el riesgo de sangrado.
    Nota: Se permite una dosis diaria de ≤100 mg de aspirina y clopidogrel como agente único

    6. Insuficiencia renal aguda o crónica con aclaramiento de creatinina < 30 ml/min.

    7. Recuento de plaquetas < 80.000/ml en el momento de la inclusión.

    8. Insuficiencia hepática grave definida por manifestaciones clínicas de ascitis, cirrosis, encefalopatía y/o ictericia y/o anomalías bioquímicas en las pruebas de función hepática, que incluyen:
    a) Niveles elevados de bilirrubina total (> 2 veces el límite superior normal [LSN]),
    b) Transaminasas hepáticas elevadas (> 2 veces el LSN; > 5 en caso de metástasis hepática).

    9. Participar en otro ensayo con un producto en investigación en el momento de la inclusión. Nota: El uso de un régimen experimental de un producto aprobado no es motivo de exclusión.

    10. Pacientes que pesan < 50 Kg.

    11. Las mujeres en edad fértil (MEF) deben proporcionar una prueba de embarazo en suero u orina negativa en la selección. Las mujeres que amamantan no son elegibles.
    Nota: Se realiza una prueba de embarazo en MEF según el estándar de atención para pacientes que se someten a tratamientos contra el cáncer.

    12. Cualquier trastorno médico o psiquiátrico subyacente que, en opinión del investigador, haga que la administración de tinzaparina sea insegura o interfiera con el proceso de consentimiento informado o los procedimientos del ensayo.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the cumulative incidence of any VTE event including:
    Symptomatic non-fatal pulmonary thromboembolism (PE).
    Symptomatic lower-limb deep vein thromboembolism (sllDVT).
    Symptomatic upper extremity deep vein thromboembolism (sueDVT).
    Incidentally diagnosed PE or proximal DVT.
    Symptomatic central venous catheter thromboembolism.
    Incidentally visceral vein thrombosis (iVVT).
    Symptomatic visceral vein thrombosis (sVVT).
    VTE-related deaths
    The primary endpoint will be calculated in specific populations (i.e. according to BRAF / RAS tumor genomic mutations, primary tumor laterality, first-line treatment with anti-EGFR or antiangiogenic, primary tumor resection, or progression status).
    La variable principal de eficacia es la incidencia acumulada de cualquier evento TEV, que incluye:
    Tromboembolismo pulmonar (TEP) sintomático no mortal.
    Tromboembolismo venoso profundo sintomático de miembros inferiores (TVPmi).
    Tromboembolismo venoso profundo sintomático de las extremidades superiores (TVPes).
    TEP o TVP proximal diagnosticados incidentalmente.
    Tromboembolismo sintomático del catéter venoso central.
    Trombosis venosa visceral (TVVi).
    Trombosis venosa visceral sintomática (TVVs).
    Muertes relacionadas con TEV
    El criterio principal de valoración se calculará en poblaciones específicas (es decir, estratificado según las mutaciones genómicas del tumor BRAF/RAS, la resección del tumor primario o el tratamiento antiangiogénico).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Through the 6 months after start of study treatment
    Durante los 6 meses tras iniciar el tratamiento de estudio
    E.5.2Secondary end point(s)
    Efficacy secondary endpoints
    Objectively confirmed VTE events (any event and each VTE event type by separate) throughout the study period and up to month 2 of end of tinzaparin treatment.
    Objectively confirmed VTE events (any event and each VTE event type by separate) in patients with BRAF / RAS tumor genomic mutations vs native BRAF / RAS tumors.
    Objectively confirmed VTE events (any event and each VTE event type by separate) in patients with primary tumor resection vs not resection.
    Objectively confirmed VTE (any event and each VTE event type by separate) in patients on antiangiogenic treatment
    Objectively confirmed VTE (any event and each VTE event type by separate) in patients on anti-EGFR
    Objectively confirmed VTE events (any event and each VTE event type by separate) in patients with right-side / transverse primary tumor vs left-side primary tumor.
    Objectively confirmed VTE events (any event and each VTE event type by separate) in patients with PD according to usual clinical practice determined by the treating physician during treatment with tinzaparin.
    Objectively confirmed VTE events (any event and each VTE event type by separate) in patients according to their genetic risk score.
    Incidence of arterial thromboembolic events (ATE)
    Thrombosis-free survival (TFS)
    Event-free survival (EFS)
    Progression-free survival (PFS)
    Overall survival (OS)
    Mortality rate throughout the study period and up to month 2 of end of tinzaparin treatment.

    Safety endpoints
    Relevant adverse events (AE), grade 3-5 according to CTCAE version 5.0.
    Treatment-related AEs (TRAEs).
    Major bleeding (MB) according to ISTH criteria throughout the study period and up to month 2 of end of tinzaparin treatment.
    Clinically relevant non-major bleeding (CRNMB) according to ISTH criteria throughout the study period and up to month 2 of end of tinzaparin treatment.
    MB and CRNMB in patients with and without RAS / BRAF mutational alterations.
    MB and CRNMB in patients with and without previous surgery of the primary tumor.
    MB and CRNMB in patients with and without first-line antiangiogenic agents treatment.
    MB and CRNMB in patients with and without first-line anti-EGFR treatment.
    MB and CRNMB in patients with right-sided or transversal vs. left-sided primary tumor.
    MB and CRNMB in patients according to their genetic risk score.
    Patients reported outcomes through the EORTC QLQ-C30 questionnaire.

    Exploratory endpoints
    Genetic and clinical risk assessment scores (including but not limited to Khorana and CATS/MICA Scores (Pabinger et al. 2018) at baseline and their evolution throughout the study period.
    OS according to genetic risk score.
    OS and VTE events according to Khorana and CATS/MICA score at baseline.
    Genetic biomarkers locally assessed, including VTE events according to MSI.
    Variables secundarias de eficacia
    Eventos TEV confirmados objetivamente (cualquier evento y cada tipo de evento TEV por separado) a lo largo del período de estudio y hasta el mes 2 del final del tratamiento con tinzaparina.
    Eventos TEV confirmados objetivamente (cualquier evento y cada tipo de evento TEV por separado) en pacientes con mutaciones genómicas tumorales BRAF/RAS frente a tumores nativos BRAF/RAS.
    Eventos TEV confirmados objetivamente (cualquier evento y cada tipo de evento TEV por separado) en pacientes con resección del tumor primario versus sin resección.
    Eventos TEV confirmado objetivamente (cualquier evento y cada tipo de evento TEV por separado) en pacientes con tratamiento antiangiogénico
    Eventos TEV confirmado objetivamente (cualquier evento y cada tipo de evento TEV por separado) en pacientes con anti-EGFR
    Eventos TEV confirmados objetivamente (cualquier evento y cada tipo de evento TEV por separado) en pacientes con tumor primario del lado derecho/transverso versus tumor primario del lado izquierdo.
    Eventos de TEV confirmados objetivamente (cualquier evento y cada tipo de evento de TEV por separado) en pacientes con PE según la práctica clínica habitual determinada por el médico tratante durante el tratamiento con tinzaparina.
    Eventos de TEV confirmados objetivamente (cualquier evento y cada tipo de evento de TEV por separado) en pacientes según su modelos de riesgo genético.
    Incidencia de eventos tromboembólicos arteriales (TEA)
    Supervivencia libre de trombosis (SLT)
    Supervivencia libre de eventos (SLE)
    Supervivencia libre de progresión (SLP)
    Supervivencia general (SG)
    Tasa de mortalidad a lo largo del período de estudio y hasta el mes 2 del final del tratamiento con tinzaparina.

    Variables secundarias de seguridad
    Eventos adversos (EA) relevantes, grado 3-5 según CTCAE versión 5.0.
    EA relacionados con el tratamiento (EART).
    Sangrado mayor (SM) según criterios ISTH durante todo el periodo de estudio y hasta 2 meses de finalizar el tratamiento con tinzaparina.
    Sangrado no mayor clínicamente relevante (SNMCR) según criterios ISTH durante todo el período de estudio y hasta el mes 2 de finalizar el tratamiento con tinzaparina.
    SM y SNMCR en pacientes con y sin alteraciones mutacionales RAS/BRAF.
    SM y SNMCR en pacientes con y sin cirugía previa del tumor primario.
    SM y SNMCR en pacientes con y sin tratamiento con agentes antiangiogénicos de primera línea.
    SM y SNMCR en pacientes con y sin tratamiento anti-EGFR de primera línea.
    SM y SNMCR en pacientes con tumor primario del lado derecho o transversal vs. del lado izquierdo.
    SM y SNMCR en pacientes según modelos de riesgo genético.
    Los pacientes informaron los resultados a través del cuestionario EORTC QLQ-C30.

    Variables exploratorias
    Modelos de evaluación del riesgo genético y clínico (incluidos, entre otros, Khorana y CATS/MICA al inicio del estudio y su evolución a lo largo del período de estudio.
    SG según los modelos de riesgo genético.
    SG y eventos TEV según Khorana y puntuación CATS/MICA al inicio del estudio.
    Biomarcadores genéticos evaluados localmente, incluyendo eventos TEV según MSI.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the study period, 6 months for VTE and bleedings, or until end of study for survival.
    Durante el estudio, 6 meses para VTE y sangrados, o hasta fin de estudio para supervivencia.
    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 No
    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
    Sin intervención, observar y esperar
    No intervention, watch & wait strategy
    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 concerned30
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    LPLV
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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: 322
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 204
    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
    ICF may be given before a witness if the patient is not capable of reading or before an acredited legal representative (only those patients legally declared uncapable).
    Standard procedures according to GCPs will apply in these cases
    El CI se puede dar ante un testigo si el paciente no es capaz de leer o ante un representante legal acreditado (solo aquellos pacientes legalmente declarados incapaces).
    En estos casos se aplicarán los procedimientos estándar de acuerdo con las BPC.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state526
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 526
    F.4.2.2In the whole clinical trial 526
    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)
    Best standard of care according to physician criteria
    Mejores opciones de cuidad de acuerdo al criterio del médico
    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 Decision2022-10-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-09-23
    P. End of Trial
    P.End of Trial StatusOngoing
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