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    Summary
    EudraCT Number:2021-003076-14
    Sponsor's Protocol Code Number:ANT-007
    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:2022-02-18
    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 number2021-003076-14
    A.3Full title of the trial
    A multicenter, randomized, open-label, blinded endpoint evaluation, phase 3 study comparing the effect of abelacimab relative to apixaban on venous thromboembolism (VTE) recurrence and bleeding in patients with cancer associated VTE
    Estudio de fase III, multicéntrico, aleatorizado, abierto, con evaluación enmascarada de los criterios de valoración, que compara el efecto de abelacimab en relación con apixaban en la
    recurrencia del tromboembolismo venoso (TEV) y la hemorragia en pacientes con TEV asociado al cáncer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Abelacimab versus apixaban in the treatment of cancer associated VTE
    Abelacimab en comparación con apixaban en el tratamiento del TEV asociado al cáncer
    A.3.2Name or abbreviated title of the trial where available
    ASTER
    ASTER
    A.4.1Sponsor's protocol code numberANT-007
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05171049
    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 SponsorAnthos Therapeutics Inc
    B.1.3.4CountryUnited States
    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 supportAnthos Therapeutics
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAnthos Therapeutics Inc
    B.5.2Functional name of contact pointInformation Desk
    B.5.3 Address:
    B.5.3.1Street Address55 Cambridge Pkwy, Ste. 103
    B.5.3.2Town/ cityCambridge, MA
    B.5.3.3Post code02142
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1617430-6940
    B.5.6E-mailinfo@anthostherapeutics.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 nameAbelacimab
    D.3.2Product code MAA868
    D.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNABELACIMAB
    D.3.9.2Current sponsor codeMAA868
    D.3.9.4EV Substance CodeSUB198013
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 Yes
    D.3.11.13.1Other medicinal product typeHuman monoclonal antibody against human FXI
    D.IMP: 2
    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 Eliquis
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb/Pfizer EEIG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNApixaban
    D.3.9.1CAS number 503612-47-3
    D.3.9.4EV Substance CodeSUB25425
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number10
    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 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
    venous thromboembolism (VTE)
    tromboembolismo venoso (TEV)
    E.1.1.1Medical condition in easily understood language
    blood clot in leg veins and/or in the pulmonary artery in the lungs
    coágulo de sangre en las venas de las piernas y/o en la arteria pulmonar en los pulmones
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to assess whether abelacimab is non-inferior to apixaban for preventing VTE recurrence at 6 months post randomization in patients with cancer and recently diagnosed VTE. If non-inferiority is demonstrated, then superiority will be assessed.
    El objetivo principal de este estudio es evaluar si abelacimab no es inferior a apixaban para prevenir la recurrencia del TEV a los 6 meses después de la aleatorización en pacientes con cáncer y TEV diagnosticado recientemente. Si se demuestra la no inferioridad, se evaluará la superioridad.
    E.2.2Secondary objectives of the trial
    •To assess whether abelacimab is superior to apixaban for preventing occurrence of the composite of major or CRNM bleeding
    •To assess whether abelacimab is superior to apixaban on net clinical benefit defined as survival without VTE recurrence, or major or CRNM bleeding events
    •To assess whether abelacimab is superior to apixaban on the rate of permanent treatment discontinuation not due to death
    •To assess whether abelacimab is superior to apixaban for preventing occurrence of CRNM bleeding events
    •To assess whether abelacimab is superior to apixaban for preventing occurrence of major bleeding events
    •To assess whether abelacimab is superior to apixaban for preventing the occurrence of the composite of GI major and GI CRNM bleeding
    •To evaluate safety and tolerability of abelacimab relative to apixaban and to assess incidence rate of injection site reactions, hypersensitivity reactions and immunogenicity in patients treated with abelacimab
    Evaluar si abelacimab es superior a apixaban para prevenir la aparición del compuesto de hemorragias graves o NGCR
    Evaluar si abelacimab es superior a apixaban en el beneficio clínico neto, definido como supervivencia sin recurrencia del TEV, o episodios hemorrágicos graves o NGCR
    Evaluar si abelacimab es superior a apixaban en cuanto a la tasa de la interrupción permanente del tratamiento no debida a la muerte
    Evaluar si abelacimab es superior a apixaban para prevenir la aparición de episodios hemorrágicos NGCR
    Evaluar si abelacimab es superior a apixaban para prevenir la aparición de episodios hemorrágicos graves
    Evaluar si abelacimab es superior a apixaban para prevenir la aparición del compuesto de hemorragia GI grave y hemorragia GI NGCR
    Evaluar la seguridad y la tolerabilidad de abelacimab en comparación con apixaban y analizar la incidencia de reacciones en el lugar de la inyección, reacciones de hipersensibilidad e inmunogenicidad en pacientes tratados con abelacimab.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacogenomic study requiring samples to be collected at Day 1 (DNA).
    Estudio farmacogenómico que requiere la recogida de muestras en el día 1 (ADN)
    E.3Principal inclusion criteria
    •Male or female subjects ≥18 years old or another legal maturity age according to the country of residence
    •Confirmed diagnosis of cancer (by histology or adequate imaging modality), other than basal-cell or squamous-cell carcinoma of the skin alone with one of the following:
    oActive cancer, defined as either locally active, regionally invasive, or metastatic cancer at the time of randomization, and/or
    oCurrently receiving or having received anticancer therapy (radiotherapy, chemotherapy, hormonal therapy, any kind of targeted therapy or any other anticancer therapy) in the last 6 months.
    •Confirmed symptomatic or incidental proximal lower limb acute DVT (i.e., popliteal, femoral, iliac, and/or inferior vena cava vein thrombosis) and/or a confirmed symptomatic or incidental PE of a segmental, or larger pulmonary artery, and/or a confirmed symptomatic or incidental PE of two or more subsegmental pulmonary arteries. Patients are eligible within 72 hours from diagnosis of the qualifying VTE.
    •Anticoagulation therapy with a therapeutic dose of DOAC for at least 6 months is indicated.
    •Able to provide written informed consent.
    • Hombres o mujeres ≥18 años o con otra edad de madurez legal según el país de residencia.
    • Diagnóstico confirmado de cáncer (mediante histología o modalidad de diagnóstico por imagen adecuada), distinto del carcinoma basocelular o espinocelular de la piel solo con uno de los siguientes:
    o cáncer activo, definido como cáncer localmente activo, regionalmente invasivo o metastásico en el momento de la aleatorización, y/o
    o estar recibiendo actualmente o haber recibido tratamiento antineoplásico (radioterapia, quimioterapia, tratamiento hormonal, cualquier tipo de tratamiento dirigido u otro tratamiento antineoplásico) en los últimos 6 meses.
    • TVP aguda proximal de las extremidades inferiores de hallazgo casual o sintomática confirmada (es decir, trombosis de la vena poplítea, femoral, ilíaca y/o vena cava inferior) y/o EP sintomática confirmada, o EP de hallazgo casual en una arteria pulmonar segmentaria o mayor. Los pacientes son aptos para participar en el plazo de 72 horas desde el diagnóstico del TEV que cumple los criterios.
    • Está indicado el tratamiento con anticoagulantes con una dosis terapéutica de AOD durante al menos 6 meses.
    • Capaces de otorgar su consentimiento informado por escrito.
    E.4Principal exclusion criteria
    •Thrombectomy, insertion of a caval filter or use of a fibrinolytic agent to treat the current (index) occurrence of DVT and/or PE
    •More than 72 hours of pre-treatment with therapeutic doses of UFH, LMWH, fondaparinux, DOAC, or other anticoagulants
    •An indication to continue treatment with therapeutic doses of an anticoagulant other than that used for VTE treatment prior to randomization (e.g., atrial fibrillation, mechanical heart valve, prior VTE)
    •Platelet count <50,000/mm3
    •PE leading to hemodynamic instability (systolic blood pressure [BP] <90 mmHg or shock)
    •Acute ischemic or hemorrhagic stroke or intracranial hemorrhage within 4 weeks preceding screening
    •Brain trauma, or a cerebral or a spinal cord surgery in the 4 weeks preceding screening
    •Need for aspirin in a dosage of more than 100 mg/per day or any other antiplatelet agent alone or in combination with aspirin
    •Primary brain cancer or untreated intracranial metastases at baseline
    •Acute myeloid or lymphoid leukemia at baseline
    •Bleeding requiring medical attention at the time of randomization or in the preceding 4 weeks
    •Planned major surgery at baseline
    •Eastern Cooperative Oncology Group (ECOG) performance status of 3 or 4 at screening
    •Life expectancy <3 months at randomization
    •Calculated creatinine clearance (CrCl) <30 mL/min (Cockcroft-Gault equation)
    •Hemoglobin less than 8 g/dL
    •Acute hepatitis, chronic active hepatitis, liver cirrhosis; or an alanine aminotransferase level 3 times or more and/or bilirubin level 2 times or more higher the upper limit of the normal range in absence of clinical explanation
    •Uncontrolled hypertension (systolic BP>180 mm Hg or diastolic BP >100 mm Hg despite antihypertensive treatment)
    •Women of child-bearing potential (WOCBP) who are unwilling or unable to use highly effective contraceptive measures during the study from screening up to 3 days after last treatment of dalteparin or 100 days after administration of abelacimab (See Section 5.3.6 for highly effective contraceptive measures).
    •Sexually active males with sexual partners of childbearing potential must agree to use a condom or other reliable contraceptive measure up to 3 days after last treatment of dalteparin or 100 days after administration of abelacimab
    •Pregnant or breast-feeding women
    •Patients known to be receiving strong dual inducers or inhibitors of both CYP3A4 and P-gp
    •History of hypersensitivity to any of the study drugs (including apixaban) or its excipients, to drugs of similar chemical classes, or any contraindication listed in the label for apixaban
    •Subjects with any condition that as judged by the Investigator would place the subject at increased risk of harm if he/she participated in the study
    •Use of other investigational (not-registered) drugs within 5 half-lives prior to enrollment or until the expected pharmacodynamic effect has returned to baseline, whichever is longer. Participation in academic non-interventional or interventional studies, comprising testing different strategies or different combinations of registered drugs is permitted.
    • Trombectomía, inserción de un filtro de la vena cava o uso de un fármaco fibrinolítico para tratar la aparición actual (índice) de TVP y/o EP
    • Más de 72 horas de tratamiento previo con dosis terapéuticas de HNF, HBPM, fondaparinux, AOD u otros anticoagulantes.
    • Una indicación para continuar con el tratamiento a dosis terapéuticas de un anticoagulante diferente al utilizado para el tratamiento del TEV antes de la aleatorización (p. ej., fibrilación auricular, válvula cardíaca mecánica, TEV anterior).
    • Recuento de plaquetas <50.000/mm3.
    • EP que provoca inestabilidad hemodinámica (tensión arterial [TA] sistólica <90 mmHg o choque).
    • Accidente cerebrovascular isquémico o hemorrágico agudo o hemorragia intracraneal en las 4 semanas anteriores a la selección.
    • Traumatismo cerebral o cirugía cerebral o de la médula espinal en las 4 semanas anteriores a la selección.
    • Necesidad de aspirina con una pauta posológica de más de 100 mg al día o cualquier otro antiagregante plaquetario solo o en combinación con aspirina.
    • Cáncer cerebral primario o metástasis intracraneal no tratada.
    • Leucemia mieloide o linfoide aguda.
    • Hemorragia que requiera asistencia médica en el momento de la aleatorización o en las 4 semanas anteriores.
    • Cirugía mayor programada al inicio.
    • Estado general 3 o 4 según la escala del Grupo Oncológico Cooperativo del Este (ECOG) en la selección.
    • Esperanza de vida <3 meses en la aleatorización.
    • Aclaramiento de creatinina (ACr) calculado <30 ml/min.
    • Hemoglobina inferior a 8 g/dl.
    • Hepatitis aguda, hepatitis crónica activa, cirrosis hepática o concentración de alanina aminotransferasa 3 veces o más y/o concentración de bilirrubina 2 veces o más que el límite superior de la normalidad en ausencia de explicación clínica.
    • Hipertensión no controlada (TA sistólica >180 mmHg o TA diastólica >100 mmHg a pesar del tratamiento antihipertensivo).
    • Mujeres en edad fértil (MEF) que no están dispuestas a utilizar métodos anticonceptivos altamente eficaces durante el estudio desde la selección hasta 3 días después del último tratamiento con apixaban o 100 días después de la administración de abelacimab o no pueden utilizarlos
    • Los hombres sexualmente activos con parejas sexuales en edad fértil deben aceptar usar un preservativo u otro método anticonceptivo fiable hasta 3 días después del último tratamiento de apixaban o 100 días después de la administración de abelacimab
    • Mujeres embarazadas o en periodo de lactancia
    • Pacientes que se sabe que están recibiendo inductores duales potentes o inhibidores de CYP3A4 y de la gp-P
    • Antecedentes de hipersensibilidad a cualquiera de los fármacos del estudio (incluido apixaban) o a sus excipientes, a fármacos de clases químicas similares o cualquier contraindicación indicada en la ficha técnica de apixaban
    • Sujetos con cualquier afección que, a criterio del investigador, implicaría un aumento del riesgo de perjuicio para el sujeto si participase en el estudio
    • Uso de otros fármacos en investigación (no registrados) en un plazo de 5 semividas previas a la inscripción o hasta que el efecto farmacodinámico previsto haya vuelto al valor inicial, lo que sea más largo. Se permite la participación en estudios académicos de intervención o no intervención, que comprenden distintas estrategias o diferentes combinaciones de fármacos registrados
    E.5 End points
    E.5.1Primary end point(s)
    Time to first event of centrally adjudicated VTE recurrence through 6 months
    Tiempo hasta el primer episodio de recurrencia de TEV adjudicado centralmente durante 6 meses
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months post randomization
    6 meses después de la aleatorización
    E.5.2Secondary end point(s)
    1. Time to first event of ISTH-adjudicated major or CRNM bleeding events through 6 months
    2. Time to first event of VTE recurrence, ISTH adjudicated major or ISTH-adjudicated CRNM bleeding events through 6 months
    3. Time to event of permanent treatment discontinuation not due to death
    4. Time to first event of ISTH-adjudicated CRNM bleeding events through 6 months
    5. Time to first event of ISTH-adjudicated major bleeding events through 6 months
    6. Time to first event of GI ISTH-adjudicated major and CRNM bleeding events through 6 months
    7. All-cause death, vascular death, serious adverse events, adverse events leading to drug discontinuation, other adverse events, abnormal lab tests, etc. presented as rate per 100 patient years
    • For patients treated with abelacimab:
    o Percentage of patients with injection site reactions
    o Percentage of patients with injection site reactions by severity status
    o Percentage of patients with hypersensitivity reactions
    o Percentage of patients with hypersensitivity reactions by severity status
    o Percentage of patients with ADA formation
    o Percentage of patients with persistent ADA formation
    o Percentage of patients with neutralizing antibody (NAb) formation.
    1. Tiempo hasta el primer episodio de hemorragias graves o NGCR durante 6 meses
    2. iempo hasta el primer episodio de recurrencia del TEV, o de hemorragias graves o NGCR durante 6 meses
    3. Tiempo hasta el primer episodio de interrupción permanente del tratamiento no debido a la muerte
    4. Tiempo hasta el primer episodio de episodios hemorrágicos NGCR durante 6 meses
    5. Tiempo hasta el primer episodio de episodios hemorrágicos graves durante 6 meses
    6. Tiempo hasta el primer episodio de hemorragia GI grave y hemorragia GI NGCR durante 6 meses
    7. Muerte por todas las causas, muerte vascular, eventos adversos graves, eventos adversos que conducen a la interrupción del medicamento, otros eventos adversos, pruebas de laboratorio anormales, etc. presentados como tasa por 100 pacientes-año
    • Para pacientes tratados con Abelacimab:
    o Porcentaje de pacientes con reacciones en el lugar de la inyección
    o Porcentaje de pacientes con reacciones en el lugar de la inyección según la gravedad
    o Porcentaje de pacientes con formación ADA
    o Porcentaje de pacientes con formación ADA persistente
    o Porcentaje de pacientes con formación de anticuerpo neutralizante (NAb)
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 months post randomization
    6 meses después de la aleatorización
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy 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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 concerned17
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA160
    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
    Australia
    Austria
    Canada
    China
    Czechia
    France
    Germany
    Hungary
    Ireland
    Italy
    Japan
    Korea, Republic of
    Latvia
    Netherlands
    Norway
    Poland
    Spain
    Sweden
    Switzerland
    Taiwan
    Ukraine
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days70
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days70
    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: 828
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 827
    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 state160
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 929
    F.4.2.2In the whole clinical trial 1655
    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)
    The patient will continue treatment according to standard of care and prevailing guidelines.
    El paciente continuará el tratamiento de acuerdo con los cuidados estándar y las directrices vigentes.
    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 Decision2022-04-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-15
    P. End of Trial
    P.End of Trial StatusOngoing
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