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    Summary
    EudraCT Number:2019-002101-21
    Sponsor's Protocol Code Number:ARGX-113-1803
    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:2020-01-23
    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 number2019-002101-21
    A.3Full title of the trial
    A Phase 3, Multicenter, Open-label, Long-term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients with Primary Immune Thrombocytopenia
    Ensayo en fase III, multicéntrico, sin enmascaramiento y a largo plazo para evaluar la seguridad y la eficacia de 10 mg/kg de efgartigimod (ARGX-113) por vía intravenosa en pacientes adultos con trombocitopenia inmunitaria primaria
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A long-term study to assess the safety and efficacy of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding)
    Estudio a largo plazo para evaluar la seguridad y la eficacia del efgartigimod en pacientes adultos con trombocitopenia inmunitaria primaria (trastorno autoinmunitario que destruye las plaquetas [células sanguíneas que ayudan a coagular la sangre] y puede provocar hematomas y hemorragias con facilidad o excesivos)
    A.3.2Name or abbreviated title of the trial where available
    ADVANCE+
    A.4.1Sponsor's protocol code numberARGX-113-1803
    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 Sponsorargenx BVBA
    B.1.3.4CountryBelgium
    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 supportargenx BVBA
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationargenx BVBA
    B.5.2Functional name of contact pointRegulatory
    B.5.3 Address:
    B.5.3.1Street AddressIndustriepark Zwijnaarde 7
    B.5.3.2Town/ cityZwijnaarde
    B.5.3.3Post codeB-9052
    B.5.3.4CountryBelgium
    B.5.4Telephone number0034932483341
    B.5.5Fax number+32 9 310 3499
    B.5.6E-mailregulatory@argenx.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 nameEfgartigimod
    D.3.2Product code ARGX-113
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    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 INNEfgartigimod alfa
    D.3.9.1CAS number 1821402-21-4
    D.3.9.2Current sponsor codeARGX-113
    D.3.9.3Other descriptive nameARGX-113
    D.3.9.4EV Substance CodeSUB180001
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Yes
    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
    Primary immune thrombocytopenia
    Trombocitopenia inmunitaria primaria
    E.1.1.1Medical condition in easily understood language
    Disorder that can lead to easy or excessive bruising and bleeding due low levels of the cells that help blood clot
    Trastorno que puede provocar hematomas y hemorragias con facilidad o excesivos debido a niveles bajos de las células que ayudan a coagular la sangre
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10050245
    E.1.2Term Autoimmune thrombocytopenia
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the long-term safety of efgartigimod in adult patients with primary immune thrombocytopenia (ITP).
    Evaluar la seguridad a largo plazo de efgartigimod en pacientes adultos con trombocitopenia inmunitaria (TPI) primaria.
    E.2.2Secondary objectives of the trial
    • To evaluate the long-term efficacy of efgartigimod on overall platelet count response.
    • To explore the potential for reduction in concurrent ITP therapy.
    • To evaluate the effects of efgartigimod treatment on quality-of-life (QoL) measures and patient-reported outcomes (PRO).
    • To assess the pharmacodynamic (PD) effects of efgartigimod.
    • To evaluate the pharmacokinetics (PK) of efgartigimod.
    • To assess the immunogenicity of efgartigimod.
    • Evaluar la eficacia a largo plazo de efgartigimod en la respuesta global del recuento plaquetario.
    • Explorar el potencial para reducir el tratamiento simultáneo para la TPI.
    • Evaluar los efectos del tratamiento con efgartigimod sobre las mediciones de la calidad de vida (CdV) y los resultados notificados por el paciente (RNP).
    • Evaluar los efectos farmacodinámicos (FD) de efgartigimod.
    • Evaluar la farmacocinética (FC) de efgartigimod.
    • Evaluar la inmunogenicidad de efgartigimod.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Ability to understand the requirements of the trial, to provide written informed consent (including consent for the use and disclosure of research-related health information), and to comply with the trial protocol procedures (including required trial visits).
    2. Patients enrolled in the ARGX-113-1801 trial who completed the 24-week trial period.
    3. Women of childbearing potential must have a negative urine pregnancy test at baseline before trial medication (infusion) can be administered. Women are considered of childbearing potential unless they are post-menopausal (defined by continuous amenorrhea) for at least 1 year with a FSH of >40 IU/L or are surgically sterilized (i.e. women who had a hysterectomy, both ovaries surgically removed, or have a documented permanent female sterilization procedure including tubal ligation). Follicle-stimulating hormone can be used to confirm post-menopausal status in amenorrheic patients not on hormonal replacement therapy.
    4. Women of childbearing potential should use a highly effective method of contraception (i.e. pregnancy rate of less than 1% per year) during the trial and for 90 days after the last administration of the IMP. They must be on a stable regimen, for at least 1 month:
    • combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation
    - oral
    - intravaginal
    - transdermal
    • progestogen-only hormonal contraception associated with inhibition of ovulation:
    - oral
    - injectable
    - implantable
    • intrauterine device (IUD)
    • intrauterine hormone-releasing system
    • bilateral tubal occlusion
    • vasectomized partner(provided that the partner is the sole sexual partner of the trial participant and that aspermia was documented post procedure)
    • continuous abstinence from heterosexual sexual contact. Sexual abstinence is only allowable if it is the preferred and usual lifestyle of the patient. Periodic abstinence (calendar, symptothermal, post-ovulation methods) is not acceptable.
    5. Non-sterilized male patients who are sexually active with a female partner of childbearing potential must use effective double contraception, being a condom for male patients and a highly effective form of contraception for the female partner of childbearing potential (same as for female patients described in inclusion criterion 4). Male patients practicing true sexual abstinence (when this is in line with the preferred and usual lifestyle of the participant) can be included. Sterilized male patients who have had vasectomy with documented aspermia post procedure can be included. In addition, male patients are not allowed to donate sperm during this period from signing of informed consent form, throughout the duration of the trial, and for 90 days after the last administration of IMP.
    1.Capacidad para comprender los requisitos del ensayo, para otorgar su consentimiento informado por escrito (incluido el consentimiento para el uso y publicación de información sanitaria relacionada con la investigación) y para cumplir con los procedimientos del protocolo del ensayo (incluidas las visitas del ensayo necesarias).
    2.Pacientes incluidos en el ensayo ARGX-113-1801 que finalizaron el periodo del ensayo de 24 semanas.
    3.Para poder recibir el medicamento (infusión) del ensayo, las mujeres con capacidad de concebir deben presentar una prueba de embarazo en orina con resultado negativo en el inicio. Las mujeres se consideran con capacidad de concebir a menos que sean posmenopáusicas (definidas como mujeres con amenorrea continua) durante al menos 1 año con unas concentraciones de hormona foliculoestimulante (FSH) >40 UI/l o que estén esterilizadas quirúrgicamente (es decir, mujeres sometidas a histerectomía, a extirpación quirúrgica de ambos ovarios o a un procedimiento documentado de esterilización femenina permanente, incluida la ligadura de trompas). La hormona foliculoestimulante se puede utilizar para confirmar el estado posmenopáusico en las pacientes amenorreicas que no reciban tratamiento de reposición hormonal.
    4.Las mujeres con capacidad de concebir deben utilizar un método anticonceptivo muy eficaz (es decir, con una tasa de embarazos inferior al 1 % anual) durante el ensayo y hasta 90 días después de la última administración del PEI. Deben estar recibiendo durante al menos 1 mes una pauta posológica estable de:
    • anticonceptivos hormonales combinados (con estrógeno y gestágeno) asociados a inhibición de la ovulación
    -orales
    -intravaginales
    -transdérmicos
    • anticonceptivos hormonales solo de gestágeno asociados a inhibición de la ovulación
    -orales
    -inyectables
    -implantables
    • dispositivo intrauterino (DIU)
    • sistema intrauterino de liberación hormonal
    • oclusión tubárica bilateral
    • vasectomía de la pareja (siempre que esta sea la única pareja sexual de la participante en el ensayo y se haya documentado la azoospermia tras el procedimiento)
    • abstinencia continua de relaciones heterosexuales. La abstinencia sexual solo será aceptable si constituye el estilo de vida habitual y preferido de la paciente. La abstinencia periódica (métodos del calendario, sintotérmico o de posovulación) no es aceptable.
    5.Los pacientes varones no esterilizados que sean sexualmente activos con una pareja de sexo femenino con capacidad de concebir deben utilizar un método anticonceptivo doble eficaz consistente en el preservativo para los pacientes de sexo masculino y un método anticonceptivo muy eficaz para la pareja de sexo femenino con capacidad de concebir (los mismos que se describen en el criterio de inclusión 4 para las pacientes del ensayo). Se puede incluir a los pacientes varones que practiquen una abstinencia sexual real (si ello concuerda con el estilo de vida habitual y preferido del participante). También se podrá incluir a los pacientes varones esterilizados que se hayan sometido a una vasectomía con azoospermia documentada posterior a la intervención. Además, los pacientes varones no podrán donar semen durante este periodo desde la firma del formulario de consentimiento informado, mientras dure el ensayo y hasta 90 días después de la última administración del PEI.
    E.4Principal exclusion criteria
    1. Introduction or continuation of non-permitted medications during the ARGX-113-1801 trial (such as anti-CD20 therapy, romiplostim, fostamatinib, monoclonal antibodies, or Fc fusion proteins).
    2. Pregnant or lactating women, and those intending to become pregnant during the trial or within 90 days after the last dosing.
    3. Patients with known medical history of hypersensitivity to any of the ingredients of efgartigimod.
    4. Use of any other investigational drug or participation in any other investigational trial.
    1.Introducción o continuación de medicamentos no permitidos durante el ensayo ARGX-113-1801 (tales como tratamiento anti-CD20, romiplostim, fostamatinib, anticuerpos monoclonales o proteínas de fusión de Fc).
    2.Mujeres embarazadas o en periodo de lactancia y aquellas que tengan intención de quedarse embarazadas durante el ensayo o en los 90 días posteriores a la última administración de la dosis.
    3.Pacientes con antecedentes médicos conocidos de hipersensibilidad a alguno de los ingredientes de efgartigimod.
    4.Uso de cualquier otro fármaco en investigación o participación en cualquier otro ensayo de investigación.
    E.5 End points
    E.5.1Primary end point(s)
    Frequency and severity of AEs, vital signs, and laboratory assessments.
    Frecuencia y gravedad de los AA, las constantes vitales y las evaluaciones analíticas.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Frequency and severity of AEs - at each visit
    Vital signs - at baseline visit (week 1), followed by every even week (week 2 to week 52) and Early discontinuation, follow-up 1 and 2, unscheduled visits.
    Laboratory assessments - please refer to protocol Table 1 Schedule of Assessments for various laboratory assessments
    Frecuencia y gravedad de los AA: en cada visita
    Constantes vitales: en la visita inicial (semana 1), en cada semana par a partir de entonces (de la semana 2 a la 52) y en la visita de finalización anticipada, en las visitas de seguimiento 1 y 2, y en visitas no programadas.
    Evaluaciones analíticas: en la tabla 1 del protocolo, Calendario de evaluaciones, figuran las diversas evaluaciones analíticas
    E.5.2Secondary end point(s)
    1. Extent of disease control defined as the number of cumulative weeks over the planned 52-week treatment period with platelet counts of ≥50×10^9/L.
    2. Percentage of patients with overall platelet count response defined as achieving a platelet count of ≥50×10^9/L on at least 4 occasions at any time during the 52-week treatment period.
    3. Mean change from baseline in platelet count at each visit.
    4. For patients rolling-over from the ARGX-113-1801 trial with a platelet count of <30×10^9/L: time to response is defined as the time to achieve 2 consecutive platelet counts of ≥50×10^9/L.
    5. The number of cumulative weeks over the planned 52-week treatment period with platelet counts of ≥30×10^9/L and at least 20×10^9/L above baseline.
    6. In patients with baseline platelet count of <15×10^9/L in the current trial (ARGX-113-1803), the number of cumulative weeks over the planned 52-week treatment period with platelet counts of ≥30×10^9/L and at least 20×10^9/L above baseline.
    7. In patients with first exposure to efgartigimod: proportion of patients who achieve a sustained platelet response defined as achieving platelet counts of at least 50×10^9/L for at least 4 of the 6 visits between visit 19 and 24 of the trial.
    8. In patients with first exposure to efgartigimod: proportion of patients in the overall population achieving platelet counts of at least 50×10^9/L for at least 6 of the 8 visits between visits 17 and 24 of the trial.
    9. Rate of receipt of rescue therapy (rescue per patient per month).
    10. Reduction in concurrent ITP therapy.
    11. Incidence and severity of the WHO-classified bleeding events.
    12. Change from baseline in PRO (FACIT-Fatigue, Fact-Th6) and QoL (SF-36) at planned visits.
    13. Incidence of anti-drug antibodies (ADA) to efgartigimod.
    14. Pharmacodynamics markers: total IgG, IgG isotypes (IgG1, IgG2, IgG3, IgG4).
    1.Grado de control de la enfermedad, definido como el número de semanas acumuladas durante el periodo de tratamiento previsto de 52 semanas con recuentos plaquetarios >=50 × 109/l.

    2.Porcentaje de pacientes con respuesta global del recuento plaquetario, definida como la consecución de un recuento plaquetario >=50 × 109/l al menos 4 veces en cualquier momento durante el periodo de tratamiento de 52 semanas.

    3.Cambio medio desde el inicio en el recuento plaquetario en cada visita.

    4.Para los pacientes que continúen del ensayo ARGX-113-1801 con un recuento plaquetario <30 × 109/l: el tiempo hasta la respuesta se define como el tiempo transcurrido hasta alcanzar 2 recuentos plaquetarios consecutivos >=50 × 109/l.

    5.Número de semanas acumuladas durante el periodo de tratamiento previsto de 52 semanas con recuentos plaquetarios >=30 × 109/l y al menos 20 × 109/l por encima del valor inicial.

    6.En los pacientes con un recuento plaquetario inicial <15 × 109/l en el ensayo actual (ARGX-113-1803), el número de semanas acumuladas durante el periodo de tratamiento previsto de 52 semanas con recuentos plaquetarios>= ≥30 × 109/l y al menos 20 × 109/l por encima del valor inicial.

    7.En los pacientes con la primera exposición a efgartigimod: proporción de pacientes que alcancen una respuesta sostenida del recuento plaquetario, definida como recuentos plaquetarios de como mínimo 50 × 109/l durante al menos 4 de las 6 visitas comprendidas entre las visitas 19 y 24 del ensayo.
    8.En los pacientes con la primera exposición a efgartigimod: proporción de pacientes de la población global con recuentos plaquetarios de como mínimo 50 × 109/l durante al menos 6 de las 8 visitas comprendidas entre las visitas 17 y 24 del ensayo.

    9.Tasa de recepción del tratamiento de rescate (medicamentos de rescate por paciente y mes).
    10.Reducción del tratamiento simultáneo para la TPI.
    11.Incidencia e intensidad de los episodios hemorrágicos según la clasificación de la OMS.

    12.Cambio desde el inicio en los RNP (FACIT-Fatigue, Fact-Th6) y CdV (SF-36) en las visitas previstas.
    13.Incidencia de anticuerpos antifármaco (AAF) contra efgartigimod.

    14.Marcadores farmacodinámicos: IgG total, isotipos de IgG (IgG1, IgG2, IgG3, IgG4).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Over the 52-week treatment period
    2. Over the 52-week treatment period
    3. At each visit
    4. At each visit
    5. Over the 52-week treatment period
    6. Over the 52-week treatment period
    7. Between visit 19 and 24
    8. Between visits 17 and 24
    9. At each visit
    10. At each visit
    11. At each visit
    12. PRO: Weeks 1, 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 47, 49, 52 of Treatment period, Early Discontinuation
    QoL: Weeks 1, 9, 17, 25, 33, 41, 49, 52 of Treatment period, Early Discontinuation
    13. Weeks 1, 5, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of Treatment period, Early Discontinuation, Follow-up 2, Unscheduled Visit
    14. Weeks 1, 5, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of Treatment period, Early Discontinuation, Follow-up 1/2, Unscheduled Visit
    1. Durante periodo tratamiento (tto.) de 52 semanas (sem)
    2. Durante periodo tto. de 52 sem
    3. En cada visita
    4. En cada visita
    5. Durante periodo tto. de 52 sem
    6. Durante periodo tto. de 52 sem
    7. Entre visitas 19 y 24
    8. Entre visitas 17 y 24
    9. En cada visita
    10. En cada visita
    11. En cada visita
    12. RNP: sem 1, 5, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 47, 49 y 52 de periodo tto. y finalización anticipada
    CdV: sem 1, 9, 17, 25, 33, 41, 49 y 52 de periodo tto. y finalización anticipada
    13. Sem 1, 5, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 y 52 de periodo tto., finalización anticipada, seguimiento 2 y visita no programada
    14. Sem 1, 5, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 y 52 del periodo de tto., finalización anticipada, seguimiento 1/2 y visita no programada
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity of efgartigimod
    Inmunogenia del efgartigimod
    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 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 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA75
    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
    Austria
    Belgium
    Bulgaria
    Canada
    Czech Republic
    France
    Germany
    Hungary
    Italy
    Japan
    Netherlands
    Poland
    Russian Federation
    Spain
    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
    UVUP
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 140
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 156
    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)
    After a patient has completed the trial or has withdrawn/discontinued early, usual treatment will be administered if required, in accordance with the trial sites' standard of care and generally accepted medical practice depending on the patient's individual needs.
    Cuando un paciente termine el estudio, o se le retire del mismo o lo abandone de forma anticipada, se le administrará el tratamiento habitual, si es necesario, de acuerdo con la práctica habitual de los centros del estudio y la práctica médica aceptada generalmente, dependiendo de las necesidades individuales del paciente.
    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 Decision2020-04-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-16
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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