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    Summary
    EudraCT Number:2016-001247-39
    Sponsor's Protocol Code Number:CV185-362
    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:2017-06-22
    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 number2016-001247-39
    A.3Full title of the trial
    A Prospective, Randomized, Open Label, Multi-center Study of the Safety and Pharmacokinetics of Apixaban versus Vitamin K Antagonist or LMWH in Pediatric Subjects with Congenital or Acquired Heart Disease Requiring Chronic Anticoagulation for Thromboembolism Prevention
    Estudio prospectivo, aleatorizado, abierto y multicéntrico sobre la seguridad y farmacocinética de Apixaban comparado con un antagonista de la vitamina K o HBPM (Heparina de Bajo Peso Molecular) en sujetos pediátricos con cardiopatías congénitas o adquiridas que requieren anticoagulación crónica para la prevención del tromboembolismo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the Safety and Pharmacokinetics of apixaban versus Vitamin K Antagonist or low molecular weight heparin in children with congenital or acquired heart disease that need anticoagulation
    Estudio sobre la seguridad y farmacocinética de Apixaban comparado con un antagonista de la vitamina K o Heparina de Bajo Peso Molecular en sujetos pediátricos con cardiopatías congénitas o adquiridas que requieren anticoagulación
    A.3.2Name or abbreviated title of the trial where available
    Safety and Pharmacokinetics of apixaban versus warfarin or low molecular weight heparin in children
    Seguridad y farmacocinética de Apixaban comparado con antagonista de la vitamina K o HBPM en niños
    A.4.1Sponsor's protocol code numberCV185-362
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1180-8978
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/254/2016
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBristol-Myers Squibb International Corporation
    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 supportBristol-Myers Squibb International Corporation
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBristol-Myers Squibb International Corporation
    B.5.2Functional name of contact pointGCT-SU
    B.5.3 Address:
    B.5.3.1Street AddressParc de l'Alliance - Avenue de Finlande, 4
    B.5.3.2Town/ cityBraine-L'Alleud
    B.5.3.3Post code1420
    B.5.3.4CountryBelgium
    B.5.4Telephone number+34 900 150 160
    B.5.6E-mailclinical.trials@bms.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 nameAPIXABAN
    D.3.2Product code BMS-562247-01
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPNasogastric use (Noncurrent)
    Oral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAPIXABAN
    D.3.9.2Current sponsor codePF-0465257/BMS-562247-01
    D.3.9.4EV Substance CodeSUB25425
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.4
    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 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 Eliquis
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb/Pfizer EEIG/Bristol-Myers Squibb House
    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.3.1Product nameAPIXABAN
    D.3.2Product code BMS-562247-01
    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.3.9.2Current sponsor codePF-0465257/BMS-562247-01
    D.3.9.4EV Substance CodeSUB25425
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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: 3
    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 WARFARIN SODIUM- warfarin sodium tablet
    D.2.1.1.2Name of the Marketing Authorisation holderTeva Pharmaceuticals USA Inc
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 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 INNWarfarin
    D.3.9.3Other descriptive nameWARFARIN SODIUM
    D.3.9.4EV Substance CodeSUB05128MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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: 4
    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 WARFARIN SODIUM- warfarin sodium tablet
    D.2.1.1.2Name of the Marketing Authorisation holderTeva Pharmaceuticals USA Inc
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 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 INNWarfarin
    D.3.9.3Other descriptive nameWARFARIN SODIUM
    D.3.9.4EV Substance CodeSUB05128MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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: 5
    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 WARFARIN SODIUM- warfarin s odium tablet
    D.2.1.1.2Name of the Marketing Authorisation holderTeva Pharmaceuticals USA Inc
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 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 INNWarfarin
    D.3.9.3Other descriptive nameWARFARIN SODIUM
    D.3.9.4EV Substance CodeSUB05128MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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: 6
    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 Clexane® multidose 100 mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis Deutschland GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNENOXAPARIN SODIUM
    D.3.9.1CAS number 9041-08-1
    D.3.9.4EV Substance CodeSUB11933MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Congenital or Acquired Heart Disease Requiring Chronic Anticoagulation for Thromboembolism Prevention
    Cardiopatías congénitas o adquiridas que requieren anticoagulación crónica para la prevención del tromboembolismo
    E.1.1.1Medical condition in easily understood language
    Congenital or Acquired Heart Disease Requiring Chronic Anticoagulation for Thromboembolism Prevention
    Cardiopatías congénitas o adquiridas que requieren anticoagulación crónica para la prevención del tromboembolismo
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10019273
    E.1.2Term Heart disease congenital
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10007636
    E.1.2Term Cardiomyopathy
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10019276
    E.1.2Term Heart disease, unspecified
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10037400
    E.1.2Term Pulmonary hypertension
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10023320
    E.1.2Term Kawasaki's disease
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objectives of this study are to assess the following in pediatric subjects with congenital or acquired heart disease
    requiring chronic prophylactic anticoagulation:
    *the safety of apixaban
    *apixaban PK, PD (by measuring FX using chromogenic assay), and anti-FXa activity
    *the effects of apixaban versus VKA antagonists or LMWH on QOL measures
    *the efficacy of apixaban for thromboprophylaxis
    *biomarkers that may reflect anticoagulant efficacy or risk of thrombosis
    Los objetivos de este estudio son evaluar siguientes parámetros en pacientes pediátricos con cardiopatías congénitas o adquiridas que requieran anticoagulación profiláctica crónica:
    * La seguridad de apixaban
     * FC, FD de apixaban (mediante la determinación del FX usando el ensayo cromogénico) y actividad anti-FXa
     * Los efectos de apixaban frente a AVK o HBPM en las medidas de la CdV
     * La eficacia de apixaban en la tromboprofilaxis
     * Los biomarcadores que pueden reflejar la eficacia anticoagulante o el riesgo de trombosis
    E.2.2Secondary objectives of the trial
    Not Applicable
    No procede
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Males and females, 34 weeks adjusted gestational age to < 18 years of age
    •Congenital or acquired heart diseases requiring chronic anticoagulation for thromboprophylaxis (eg, single ventricle physiology including all 3 stages of palliation, dilated cardiomyopathy, Kawasaki disease with coronary aneurysms, and pulmonary hypertension)
    •Eligible patients include those who newly start anticoagulants and those who are currently on VKA or LMWH or other anticoagulants for thromboprophylaxis
    •Able to tolerate enteral medication [eg, by mouth, nasogastric tube, or gastric tube]
    •Varones y mujeres, de entre 34 semanas de edad gestacional ajustada y <18 años de edad
    •Cardiopatías congénitas o adquiridas que requieren anticoagulación crónica para la tromboprofilaxis (por
    ejemplo, fisiología del ventrículo único incluyendo las 3 etapas de paliación, miocardiopatía dilatada,
    enfermedad de Kawasaki con aneurismas coronarios e hipertensión pulmonar).
    •Los sujetos aptos incluyen aquellos que recién inician anticoagulantes y aquellos que están actualmente recibiendo AVK o HBPM u otros anticoagulantes para la tromboprofilaxis.
    •Capaz de tolerar la medicación enteral [por ejemplo, por vía oral, sonda nasogástrica (NG) o sonda gástrica-
    (G)]
    E.4Principal exclusion criteria
    •Recent thromboembolic events less than 6 months prior to enrollment
    •Use of aggressive life-saving therapies such as ventricular assist devices (VAD) or extracorporeal membrane oxygenation (ECMO) at the time of enrollment
    •Prosthetic heart valves and mechanical heart valves
    •Known inherited bleeding disorder or coagulopathy (e.g. hemophilia, von Willebrand disease, etc.)
    •Active bleeding at the time of enrollment
    •Any major bleeding other than perioperative in the preceding 3 months
    •Known intracranial congenital vascular malformation or tumor
    •Acontecimientos tromboembólicos recientes, menos de 6 meses antes del reclutamiento
    •El uso de terapias agresivas que salvan vidas tales como dispositivos de asistencia ventricular (DAV) u oxigenación de membrana extracorpórea (OMEC) en el momento del reclutamiento
    •Válvulas cardíacas protésicas y válvulas cardíacas mecánicas
    •Trastornos hemorrágicos hereditarios conocidos o coagulopatía (por ejemplo, hemofilia, enfermedad de von
    Willebrand, etc.)
    •Hemorragia activa en el momento del reclutamiento
    •Cualquier hemorragia mayor distinta de la perioperatoria en los 3 meses anteriores
    •Malformación vascular congénita intracraneal conocida o tumor
    E.5 End points
    E.5.1Primary end point(s)
    •A composite of adjudicated major or clinically relevant non-major (CRNM) bleeding events per the Perinatal and Paediatric Haemostasis Subcommittee of the International Society on Thrombosis and Haemostasis (ISTH) criteria
    Major bleeding is defined as bleeding that satisfies one or more of the following criteria:
    •fatal bleeding
    •clinically overt bleeding associated with a decrease in hemoglobin of at least 20 g/L (ie, 2 g/dL) in a 24 hour period
    •bleeding that is retroperitoneal, pulmonary, intracranial, or otherwise involves the central nervous system
    •bleeding that requires surgical intervention in an operating suite, including interventional radiology

    CRNM bleeding is defined as bleeding which satisfies one or both of the following criteria:
    •overt bleeding for which blood product is administered and that is not directly attributable to the subject's underlying medical condition
    •bleeding that requires medical or surgical intervention to restore hemostasis, other than in an operating room
    •Una combinación de los acontecimientos hemorrágicos mayores o no mayores clínicamente relevantes (CRNM) juzgados por el subcomité de Hemostasia perinatal y pediátrica de la Sociedad Internacional de Trombosis y Hemostasis (ISTH).
    Las definiciones de hemorragia se describen como sigue:
    La hemorragia mayor se define como la hemorragia que satisface uno o más de los siguientes criterios:
    •Hemorragia mortal
    •Hemorragia manifiestamente clínica asociada con un descenso de hemoglobina de al menos 20 g/l (es decir,
    2 g/dl) en un período de 24 horas
    •hemorragia retroperitoneal, pulmonar, intracraneal o de otro tipo que afecte al SNC
    •hemorragia que requiere intervención quirúrgica en una sala de operaciones, incluyendo radiología intervencionista

    La hemorragia CRNM se define como hemorragia que satisface uno o ambos de los siguientes criterios:
    •hemorragia manifiesta para la cual se administra el producto sanguíneo y no directamente atribuible a la
    enfermedad clínica subyacente del sujeto
    •hemorragia que requiere intervención médica o quirúrgica para restablecer la hemostasia, excepto en una sala de
    operaciones
    E.5.1.1Timepoint(s) of evaluation of this end point
    14 months
    14 meses
    E.5.2Secondary end point(s)
    •Apparent total body clearance
    •Central volume of distribution
    •Absorption rate constant
    •Cmax
    Maximum observed concentration
    •Cmin
    Trough observed concentration
    •AUC (TAU) Area under the concentration-time curve in one dosing interval
    •Factor X activity measured using chromogenic assay
    •Anti-FXa (Anti-factor 10a) activity measured using chromogenic assay
    •Exposure-response (E-R) relationships
    •Any thromboembolic events detected by imaging or clinical diagnosis Thromboembolic events include but are not limited to: intra-cardiac, shunt, inside Fontan pathway, pulmonary embolism (PE), stroke, other venous or arterial thromboembolic events
    •Thromboembolic event-related death
    •Patient/proxy reported outcome or quality of life Determined by The Pediatric Quality of Life Inventory (PedsQL) generic core and cardiac modules, and Kids Informed Decrease Complications Learning on Thrombosis (KIDCLOT©) pediatric quality of life inventory
    •Adjudicated major bleeding
    •Adjudicated CRNM bleeding
    •All bleeding
    This includes minor bleeding, which is defined as any overt or macroscopic evidence of bleeding that does not fulfill the criteria for either major bleeding or CRNM bleeding
    •Drug discontinuation
    Can be due to adverse effects, intolerability, or bleeding
    •All causes of death
    •CLT/F
    •Vc/F
    •Tasa de absorción
    •Cmax
    •Cmin
    •AUC (TAU)
    •medición de FX usando el ensayo cromogénico
    •la actividad anti-FXa usando el ensayo cromogénico
    •Relación exposición-respuesta
    •Cualquier acontecimiento tromboembólico detectado por imagen o diagnóstico clínico. Los eventos tromboembólicos incluyen pero no se limitan a: intracardíaco, shunt, dentro de la vía Fontan, PE, accidente cerebrovascular, otros acontecimientos tromboembólicos arteriales o venosos
    • muerte relacionada con el acontecimiento tromboembólico.
    •Resultado informado por el paciente/aproximación o calidad de vida (por ejemplo, los módulos genéricos
    básico y cardiaco de PedsQL y KIDCLOT©)
    •Hemorragia mayor adjudicada
    •Hemorragia CRNM adjudicada
    •Toda hemorragia
    •Interrupción del fármaco debido a efectos adversos, intolerancia o hemorragia
    •Muerte por cualquier causa
    E.5.2.1Timepoint(s) of evaluation of this end point
    14 months
    14 meses
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    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 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 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 EEA27
    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
    Argentina
    Australia
    Austria
    Brazil
    Canada
    Finland
    Germany
    Israel
    Italy
    Mexico
    Spain
    United Kingdom
    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
    The date of the last subject visit OR the date at which the last data point from the last subject that was required for statistical analysis (ie, key safety and efficacy results for decision making), was received, whichever is the later date.
    La fecha de la última visita del último paciente o la fecha de recepción del último dato del último paciente que se requiera para el análisis estadístico (por ejemplo resultados clave de seguridad y eficacia para la toma de decisiones), aquello que se produzca más tarde.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days19
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days29
    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: 150
    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: 30
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 60
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 60
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Paedatric population : Children from 2 to < 18 years old
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 81
    F.4.2.2In the whole clinical trial 150
    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)
    Post study follow-up at Month 14 (+/- 2 weeks) or 2 months after completion of anticoagulation (if the duration of anticoagulation is fewer than 12 months) is of critical importance and is essential to preserving subject safety and the integrity of the study. Subjects who discontinue study drug must continue to be followed for collection of outcome and/or survival follow-up data as required and in line with Section 5 of the protocol until death or the conclusion of the study.
    El seguimiento post-estudio en el Mes 14(+/-2 semanas) o 2 meses tras finalizar la anticoagulación (si la duración de la anticoagulación es < 12 meses) es de importancia crítica y esencial para preservar la seguridad de los sujetos e integridad del estudio.Los sujetos que interrumpan el fármaco de estudio deben continuar en seguimiento para la recogida de cualquier resultado y/o dato de supervivencia según se requiera y en línea con la Sec. 5 del protocolo hasta muerte o conclusión del estudio.
    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 Decision2017-09-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-26
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-10-18
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