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    Summary
    EudraCT Number:2018-002473-21
    Sponsor's Protocol Code Number:ERGCR-18-ORGHIT-001
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-04-11
    Trial results View 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 number2018-002473-21
    A.3Full title of the trial
    An Open-Label, Randomised, Active Controlled, Multi-Centre Phase 3 Study to Evaluate the Safety and Efficacy of Danaparoid vs Argatroban in Treatment of Subjects with Acute HIT (HITSOVA study)
    Estudio de fase III multicéntrico, abierto, aleatorizado y comparativo con tratamiento activo para evaluar la seguridad y la eficacia del Danaparoide frente al Argatroban en el tratamiento de sujetos con cuadro agudo de TIH (estudio HITSOVA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The study evaluate the safety and efficacy of danaparoid vs argatroban in treatment of subjects with acute heparin-induced-thrombocytopenia (HITSOVA)
    El estudio evalúa la seguridad y eficacia de danaparoid frente a argatroban en el tratamiento de sujetos con trombocitopenia aguda inducida por heparina (estudio HITSOVA)
    A.3.2Name or abbreviated title of the trial where available
    HITSOVA
    HITSOVA
    A.4.1Sponsor's protocol code numberERGCR-18-ORGHIT-001
    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 SponsorAspen Global Incorporated
    B.1.3.4CountryMauritius
    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 supportAspen Global Incorporated
    B.4.2CountryMauritius
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAspen Pharma Trading Limited
    B.5.2Functional name of contact pointElen Shiryayeva
    B.5.3 Address:
    B.5.3.1Street Address3016 Lake Drive, Citywest
    B.5.3.2Town/ cityDublin
    B.5.3.3Post code24
    B.5.3.4CountryIreland
    B.5.4Telephone number+35387 7076423
    B.5.6E-mailkir.cttrials@ie.aspenpharma.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 Yes
    D.2.1.1.1Trade name Orgaran,750 anti-Xa units/0.6ml, Solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderAspen Pharma Trading Limited
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 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 INNDanaparaoid sodium
    D.3.9.1CAS number 0083513-48-8
    D.3.9.3Other descriptive nameDANAPAROID SODIUM
    D.3.9.4EV Substance CodeSUB13532MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.4 to 0.8
    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.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 Exembol Multidose 100 mg/ml concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderMitsubishi Tanabe Pharma Europe Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Concentrate for solution for peritoneal dialysis
    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 INNArgatroban monohydrate
    D.3.9.1CAS number 74863-84-6
    D.3.9.3Other descriptive nameARGATROBAN MONOHYDRATE
    D.3.9.4EV Substance CodeSUB48842
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number1 mg/ml
    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
    Acute Heparin-induced Thrombocytopenia (HIT)
    Cuadro agudo de trombocitopenia inducida por heparina (TIH)
    E.1.1.1Medical condition in easily understood language
    Acute Heparin-induced Thrombocytopenia (HIT)
    Cuadro agudo de trombocitopenia inducida por heparina (TIH)
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10062506
    E.1.2Term Heparin-induced thrombocytopenia
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To show that for the treatment of subjects with acute heparin-induced thrombocytopenia (HIT) danaparoid use is not inferior to argatroban in terms of efficacy.
    Demostrar que para el tratamiento de sujetos con cuadro agudo de trombocitopenia inducida por heparina (TIH), el uso del danaparoide no es inferior al del argatroban en términos de eficacia.
    E.2.2Secondary objectives of the trial
    To collect additional efficacy data
    To describe the safety of danaparoid in comparison to argatroban
    Recoger datos adicionales sobre la eficacia
    Para describir la seguridad de danaparoide en comparación con argatroban
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    At the time of enrolment subjects are eligible to be included in the study only if all of the following criteria apply:
    1. Signed written informed consent by the subject, or if the subject is unable to do so, then consent will be sought from a family member, or a legally accepted representative
    2. Males or females aged ≥2 weeks
    3. Subjects with suspected HIT by 4Ts of >3 and with reduction of platelet count of at least 30% between day 4 and 14 of heparin exposure or at Day 1 of heparin exposure with pre-treatment with heparin within the last 30 days, with or without thrombosis.
    4. Have adequate renal function: Glomerular filtration rate ≥ 15 mL/min
    5. Male participants:
    A male participant must agree to use contraception during the treatment period and for at least 5 days after the last dose of study intervention and refrain from donating sperm during this period.
    6. Female participants:
    A female participant is eligible to participate if 1 of the following conditions applies:
    a. Not a woman of childbearing potential
    OR
    b. A woman of childbearing potential who agrees to follow the contraceptive guidance during the treatment period and for at least 5 days corresponding to time needed to eliminate study intervention. (Subjects taking oral contraceptives or hormone replacement therapy must have a stable dose and regimen for ≥ 3 months prior to entry into the study.)
    7. Understanding/willingness by the subject or his/her legally accepted representative to participate in the clinical study and ability to comply with study procedures and the study visit schedule
    En la fase de inclusión, los sujetos únicamente son aptos para ser incluidos en el estudio si satisfacen todos los criterios indicados a continuación:
    1. Consentimiento informado por escrito y firmado por el sujeto, o si el sujeto no puede hacerlo, deberá obtenerse el consentimiento de un familiar o de un representante legalmente autorizado.
    2. Hombres y mujeres con edades ≥2 semanas
    3. Sujetos con sospecha de TIH por 4Ts >3 y con un descenso del recuento de plaquetas de al menos el 30 % entre el día 4 y el 14 de exposición a la heparina o en el Día 1 de exposición a la heparina con tratamiento previo de heparina en los últimos 30 días, con o sin trombosis.
    4. Tienen una función renal adecuada: Tasa de filtración glomerular ≥ 15 ml/min
    5. Participantes masculinos:
    Los participantes masculinos deben aceptar usar métodos anticonceptivos durante el período de tratamiento y durante al menos 5 días después de la última dosis del estudio y abstenerse de donar esperma durante este período.
    6. Participantes femeninas:
    Las participantes femeninas son aptas para participar si reúnen una de las siguientes condiciones:
    a. No son mujeres en edad de procrear
    O
    b. Mujeres en edad de procrear que acepten seguir métodos anticonceptivos durante el período de tratamiento y durante al menos los 5 días correspondientes al tiempo necesario para eliminar el fármaco en estudio. (Los sujetos que tomen anticonceptivos orales o de reemplazo hormonal deben mantener una dosis y un régimen estable durante ≥ 3 meses antes de ingresar en el estudio)
    7. Compresión/voluntad por parte del sujeto o de su representante legalmente autorizado a participar en el ensayo clínico y capacidad de cumplir los procedimientos del estudio y el calendario de visitas del estudio.
    E.4Principal exclusion criteria
    At the time of enrolment subjects are excluded from the study if any of the following criteria apply:
    1. Premature infants (corrected age <37 weeks gestational age)
    2. Expectation of cardiac surgery within the next 44 days
    3. Life expectancy clearly less than the 44 days
    4. Recent fibrinolytic therapy since the start of heparin therapy leading to the target indication for enrolment, HIT
    5. Lumbar puncture or spinal/epidural catheter placement within the past 48 hours
    6. Severe hepatic impairment (Child-Pugh Class C)
    7. Active bleeding
    8. An unexplained activated partial thromboplastin time (aPTT) > 2 x the normal range
    9. Any cerebrovascular accident within the previous 3 months or has a history of haemorrhagic cerebrovascular incidence
    10. Severe, uncontrolled hypertension defined as blood pressure >180/110 mmHg
    11. Diabetic retinopathy
    12. Acute bacterial endocarditis
    13. Expectation of a long-term (> 3 weeks) haemodialysis requirement before the end of the acute treatment
    14. Hypersensitivity to the active substances or to any of the excipients
    15. Hypersensitivity to sulphite
    16. Any investigational drug(s) use within 4 weeks preceding Screening or anticipated use during the course of the study
    17. Pregnant or breastfeeding woman
    18. Use of intra-aortic balloon pump, or ventricular assist device
    En la fase de inclusión, los sujetos serán excluidos del estudio si cumplen alguno de los criterios indicados a continuación:
    1. Bebés prematuros (edad corregida < 37 semanas edad gestacional)
    2. Expectativa de cirugía cardíaca en los 44 días sigu8ientes
    3. Esperanza de vida claramente inferior a 44 días
    4. Tratamiento fibrinolítico reciente desde el comienzo del tratamiento de heparina que resulta en la indicación necesaria para la inclusión, la TIH.
    5. Punción lumbar o colocación de un catéter espinal/epidural en las últimas 48 horas
    6. Insuficiencia hepática severa (Clase C de la escala Child-Pugh)
    7. Hemorragia activa
    8. Tiempo de tromboplastina parcial activado (TTPa) inexplicable >2 veces el rango normal.
    9. Accidente cerebrovascular en los 3 meses anteriores o historial de incidencia cerebrovascular hemorrágica.
    10. Hipertensión severa descontrolada definida como presión arterial >180/110 mmHg
    11. Retinopatía diabética
    12. Endocarditis bacteriana aguda
    13. Expectativa de hemodiálisis a largo plazo (> 3 semanas) antes de acabar el tratamiento agudo
    14. Hipersensibilidad a las sustancias activas o a alguno de los excipientes
    15. Hipersensibilidad al sulfito
    16. Uso de un fármaco experimental durante las 4 semanas anteriores a la preselección o uso previsto durante el estudio
    17. Mujer embarazada o lactante
    18. Uso de un balón de contrapulsación intraórtico, o de un dispositivo de asistencia ventricular
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint (composite endpoint) is defined as treatment response at Day 44.
    A subject will be considered a treatment responder, if none of the following events occur by Day 44:
    • New or extended venous and/or arterial thrombosis, including gangrene/skin necrosis
    Note: ‘thrombosis’ denotes venous and/or arterial here and throughout the protocol
    • All-cause mortality
    • Unplanned amputation, including ischaemic gut resection
    El principal criterio de valoración de la eficacia (criterio de valoración compuesto) se define como la respuesta al tratamiento en el Día 44.
    Se considerará que un sujeto responde al tratamiento si antes del Día 44 no se ha producido ninguno de los eventos indicados a continuación:
    • Trombosis venosa nueva o extensa y/o trombosis arterial, incluida gangrena/necrosis cutánea
    Nota: 'trombosis' designa aquí y en todo el protocolo, venosa y/o arterial.
    • Mortalidad por cualquier causa
    • Amputación imprevista, incluida la resección en isquemia intestinal
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 44
    Día 44
    E.5.2Secondary end point(s)
    Secondary
    • Percentage of subjects with consistent increases in platelets at days 3, 5, and 7 (evidence of early response), defined as monotonically increasing platelet counts, measured 2 days apart on days 3 (±1 day), 5 (±1 day) and 7 (±1 day).
    • Deaths due to TE or bleeding up until Day 44
    • Incidence of fatal or non-fatal major bleeding up until Day 44
    Note: As outlined by the Control of Anticoagulation Subcommittee major bleeding in non-surgical patients is defined as:
    1. Fatal bleeding, and/or
    2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or
    3. Bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/ L) or more, or leading to transfusion of two or more units of whole blood or red cells
    • New or extended thrombosis, including gangrene/skin necrosis
    • Unplanned amputation, including ischaemic gut resection
    • All-cause mortality
    Exploratory
    • Time to first event (new/extended thrombosis, all cause mortality, unplanned amputation)
    • Time to reach consistent increase in 3 consecutive alternate day platelet count measurements during acute treatment
    • Incidence of new or extended TE events, including gangrene/skin necrosis up until Day 14
    • Incidence of all-cause mortality up until Day 14
    • Incidence of unplanned amputation up until Day 14
    • Incidence of fatal or non-fatal major bleeding up until Day 14
    • All-cause mortality
    • Incidence of fatal and non-fatal major bleeding events (as defined above) during the acute treatment and then the entire follow-up period (until Day 44)
    • Incidence of serious adverse events (SAEs)
    • Incidence of adverse events (AEs)
    • Changes in vital parameters (heart rate, blood pressure, and respiratory rate) and 12-lead electrocardiogram (ECG)
    • Incidence of positive pre-danaparoid cross reactivity in the Greinacher Heparin-induced Platelet Activation (HIPA) assay
    • Safety laboratory parameters
    Secundario
    • Porcentaje de sujetos con aumentos sistemáticos del número de plaquetas en los días 3, 5 y 7 (evidencia de respuesta temprana), definidos como recuentos de plaquetas monotónicamente crecientes, medidos con un intervalo de 2 días los días 3 (±1 día), 5 (±1 día) y 7 (±1 día).
    • Fallecimientos debidos a TE o hemorragia hasta el Día 44.
    • Incidencia de hemorragia grave fatal o no fatal hasta el Día 44.
    Nota: Tal como destaca el Subcomité de Control de la Anticoagulación, la hemorragia grave en pacientes no quirúrgicos se define como:
    1. Hemorragia fatal, y/o
    2. Hemorragia sintomática en una zona u órgano crítico como la zona intracraneal, intraespinal, intraocular, retroperitoneal, intraarticular o pericárdica, o intramuscular con síndrome compartimental, y/o
    3. Hemorragia que provoque una caída del nivel de hemoglobina de 20 g/l (1,24 mmol/l) o más, o que exija una transfusión de dos o más unidades de sangre entera o glóbulos rojos.
    • Trombosis venosa nueva o extensa, incluida gangrena/necrosis cutánea
    • Amputación imprevista, incluida la resección en isquemia intestinal
    • Mortalidad por cualquier causa
    Exploratoria
    • Momento del primer evento (trombosis nueva o extensa, mortalidad por cualquier causa, amputación imprevista).
    • Momento en que se alcanza el aumento sistemático en 3 mediciones consecutivas del recuento de plaquetas en días alternos durante el tratamiento agudo.
    • Incidencia de eventos de TE nueva o extensa, incluida gangrena/necrosis cutánea hasta el Día 14.
    • Incidencia de la mortalidad por cualquier causa hasta el Día 14.
    • Incidencia de la amputación imprevista hasta el Día 14.
    • Incidencia de hemorragia grave fatal o no fatal hasta el Día 14.
    • Mortalidad por cualquier causa
    • Incidencia de eventos de hemorragia fatal o no fatal (tal como se han definido antes) durante el tratamiento agudo y después durante el completo período de seguimiento (hasta el Día 44)
    • Incidencia de eventos adversos graves (EAGs)
    • Incidencia de eventos adversos (EAs)
    • Cambios en las constantes vitales (ritmo cardíaco, presión arterial y frecuencia respiratoria) y electrocardiograma (ECG)
    • Incidencia de reactividad pre-danaparoide cruzada positiva en el ensayo de Activación plaquetaria inducida por heparina (APIH) de Greinacher.
    • Parámetros de seguridad de laboratorio
    E.5.2.1Timepoint(s) of evaluation of this end point
    Increases in platelets at days 3,5,7
    Death until Day 44
    Bleeding at Day 44
    Time to first bleeding
    Time to reach consistent increase in 3 consecutive alternate day platelet count measurements during acute treatment
    Incidence of new event until Day 14
    Aumentos en plaquetas los días 3,5,7
    Muerte hasta el día 44
    Sangrado en el día 44
    Hora de la primera hemorragia
    Tiempo para alcanzar un aumento constante en 3 mediciones consecutivas de recuento de plaquetas en días alternos durante el tratamiento agudo
    Incidencia del nuevo evento hasta el día 14
    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 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) 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA54
    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
    Bosnia and Herzegovina
    Bulgaria
    Canada
    Croatia
    Czech Republic
    France
    Germany
    Hungary
    Italy
    Poland
    Russian Federation
    Serbia
    Spain
    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
    Last patient last visit
    Ultima visita del ultimo paciente
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 12
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 4
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 4
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 4
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 486
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patient can develop a cardio-pulmonar thrombosis/embolism /cerebrovascular event and might be in the situation where a direct cooperation with the patient is not possible (patient is unconscious due to the event or because of the intensive treatment
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 508
    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)
    Expected normal treatment of that condition
    Se espera un tratamiento normal de esa condición
    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 Decision2019-06-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-29
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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