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    Summary
    EudraCT Number:2014-002385-74
    Sponsor's Protocol Code Number:BAY59-7939/17618
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-01-26
    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 number2014-002385-74
    A.3Full title of the trial
    7-day study of the safety, efficacy and the pharmacokinetic and pharmacodynamic properties of oral rivaroxaban in children from birth to less than 6 months with catheter-related arterial or venous thrombosis.
    Ensayo clínico para evaluar la seguridad, la eficacia y las propiedades farmacocinéticas y farmacodinámicas de rivaroxabán oral, durante 7 días de tratamiento, en neonatos hasta menos de 6 meses con trombosis arterial o venosa debida al uso de catéter
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Rivaroxaban for treatment of venous or arterial blood clots in children from birth to less than 6 months
    Rivaroxabán en neonatos hasta menos de 6 meses para el tratamiento de trombosis arterial o venosa
    A.3.2Name or abbreviated title of the trial where available
    EINSTEIN Junior Phase l/ll in children from birth to less than 6 months.
    Einstein Junior Fase I/II en neonatos hasta menos de 6 meses
    A.4.1Sponsor's protocol code numberBAY59-7939/17618
    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 SponsorBayer HealthCare AG
    B.1.3.4CountryGermany
    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 supportBayer HealthCare AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer HealthCare AG
    B.5.2Functional name of contact pointBayer Clinical Trials Contact
    B.5.3 Address:
    B.5.3.1Street AddressCTP Team/Ref:"EU CTR"/ Bayer Pharma AG
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.4Telephone number0034.900102372
    B.5.6E-mailgeraldine.chaikin@bayer.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 namerivaroxaban
    D.3.2Product code BAY59-7939
    D.3.4Pharmaceutical form Oral suspension
    D.3.4.1Specific paediatric formulation Yes
    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 INNRIVAROXABAN
    D.3.9.1CAS number 366789-02-8
    D.3.9.2Current sponsor codeBAY59-7939
    D.3.9.4EV Substance CodeSUB29263
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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.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
    Catheter related venous or arterial thrombosis
    Trombosis arterial o venosa debida al uso de catéter
    E.1.1.1Medical condition in easily understood language
    Blood clot in a vein or artery related to a catheter.
    Coagulo arterial o venoso debido al uso de catéter
    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
    to characterize the pharmacokinetic/pharmacodynamic profile of a 7-day treatment with oral rivaroxaban
    caracterizar el perfil farmacocinético y farmacodinámico del tratamiento con rivaroxabán oral durante 7 días.
    E.2.2Secondary objectives of the trial
    - to assess the incidence of major bleeding and clinically relevant non-major bleeding
    - to assess the incidence of symptomatic recurrent thromboembolism and
    - to assess asymptomatic deterioration in the thrombotic burden on repeat imaging
    ? evaluar la incidencia de hemorragias graves y de hemorragias no graves clínicamente relevantes
    ? evaluar la incidencia de tromboembolismo sintomático recurrente
    ? evaluar el deterioro asintomático de la carga trombótica mediante exploraciones de imagen repetidas
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Children from birth to less than 6 months with documented symptomatic or asymptomatic catheter-related venous or arterial thrombosis who will enter their last 7 days of intended anticoagulant treatment.
    2.Gestational age at birth of at least 37 weeks.
    3.Hemoglobin, platelets assessed within 10 days prior to enrollment.
    4.Oral feeding/nasogastric/gastric feeding for at least 10 days.
    5.Informed consent provided.
    1.Neonatos hasta < 6 meses de edad con trombosis arterial o venosa confirmada, sintomática o asintomática y debida al uso de catéter, tratados durante un mínimo de dos semanas con tratamiento anticoagulante.
    2.Semana 37 como mínimo de edad gestacional al nacer
    3.Hemoglobina, plaquetas, creatinina, alanina-aminotransferasa (ALT) y bilirrubina total y directa evaluadas durante los 10 días previos a la inclusión
    4.Alimentación oral / alimentación gástrica / nasogástrica durante al menos 10 días.
    5.Otorgamiento del consentimiento informado
    E.4Principal exclusion criteria
    1. Active bleeding or high risk for bleeding contraindicating anticoagulant therapy,
    including history of intra-ventricular bleeding.
    2. Symptomatic progression of thrombosis during preceding anticoagulant treatment.
    3. Planned invasive procedures, including lumbar puncture and removal of nonperipherally
    placed central lines during study treatment.
    4. Hepatic disease which is associated with either: coagulopathy leading to a clinically
    relevant bleeding risk, or alanine aminotransferase (ALT) > 5x upper level of normal
    (ULN) or total bilirubin (TB) > 2x ULN with direct bilirubin > 20% of the total.
    5. Creatinine >1.5 times of normal.
    6. Hypertension defined as >95th percentile.
    7. History of gastrointestinal disease or surgery associated with impaired absorption.
    8. Platelet count <100 x 109/L.
    9. Concomitant use of strong inhibitors of both cytochrome P450 isoenzyme 3A4
    (CYP3A4) and P-glycoprotein (P-gp).
    10. Concomitant use of strong inducers of CYP3A4.
    11. Indication for anticoagulant therapy other than current thrombosis.
    12. Indication for antiplatelet therapy or non-steroid anti-inflammatory drug (NSAID)
    therapy.
    13. Hypersensitivity to rivaroxaban or its excipients.
    14. Participation in a study with an investigational drug or medical device within 30 days
    prior to enrollment.
    1.Hemorragia activa o riesgo alto de hemorragia que contraindica el tratamiento anticoagulante, incluyendo historia de hemorragia intra-ventricular.
    2.Progresión sintomática de la trombosis durante el tratamiento anticoagulante anterior
    3.Procedimientos invasivos programados para ser realizados durante el tratamiento del estudio, como punción lumbar y retirada de vías centrales de acceso no periférico
    4.Hepatopatía asociada a: coagulopatía que conlleva riesgo de hemorragia clínicamente relevante, o ALT > 5 veces el límite superior de la normalidad (LSN) o bilirrubina total > 2 veces el LSN con bilirrubina directa> 20 % del total
    5.Creatinina >1,5 veces más de lo normal
    6.Hipertensión arterial definida como > percentil 95
    7.Historia de enfermedad gastrointestinal o cirugía asociada a una alteración de la absorción.
    8.Cifra de plaquetas < 100 x 109/L
    9.Uso concomitante de inhibidores potentes de la isoenzima 3A4 del citocromo P450 (CYP3A4) y de la glucoproteína P (GPP).
    10.Uso concomitante de inductores potentes de CYP3A4
    11.Indicación para la terapia anticoagulante que no sea la trombosis actual.
    12.Indicación para la terapia antiplaquetaria o terapia con medicamentos anti-inflamatorios no esteroideos (AINE)
    13.Hipersensibilidad a Rivaroxaban o a sus excipientes.
    14.Participación en un estudio con un fármaco o producto sanitario en investigación en los 30 días previos a la inclusión.
    E.5 End points
    E.5.1Primary end point(s)
    PK/PD modeling, using population approaches will be used to describe the pharmacokinetics of rivaroxaban, and to relate anticoagulant parameters of rivaroxaban with plasma concentrations.
    Se utilizará el modelado FC/FD con métodos poblacionales para describir la farmacocinética de rivaroxabán, y para relacionar los parámetros anticoagulantes de rivaroxabán con las concentraciones plasmáticas
    E.5.1.1Timepoint(s) of evaluation of this end point
    After last patient. last visit
    Después de la última visita del último paciente
    E.5.2Secondary end point(s)
    1. The occurrence of recurrent venous or arterial thromboembolism and asymptomatic deterioration in thrombotic burden will be summarized.
    2. All safety analyses will be performed on the safety population. Bleeding events observed later will be described separately. Individual listings of major and clinically relevant non-major bleeding will be provided.
    3. The occurrence of recurrent venous or arterial thromboembolism and asymptomatic deterioration in thrombotic burden
    1. Se resumirá la incidencia de tromboembolia venosa o arterial recurrente y el deterioro asintomático de la carga trombótica.
    2. Todos los análisis de la seguridad se efectuarán en la población para el análisis de la seguridad. Los acontecimientos hemorrágicos observados más tarde se describirán por separado. Se proporcionarán listados individuales de las hemorragias graves y de las no graves clínicamente relevantes.
    3. La incidencia de tromboembolia venosa o arterial recurrente y el deterioro asintomático de la carga trombótica.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. After last patient, last visit
    2.The analysis will primarily focus on bleeding that occurred during or within 2 days after stop of rivaroxaban
    3. After last patient, last visit
    1. Después de la última visita del último paciente
    2. El análisis se centrará principalmente en las hemorragias que se produzcan durante o en los 2 días posteriores a la suspensión de rivaroxabán
    3. Después de la última visita del último paciente
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    pharcokinetics and pharmacodymamics study
    estudios farmacocinéticos y farmacodinámicos
    E.7.2Therapeutic exploratory (Phase II) No
    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 No
    E.8.1.2Open No
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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
    France
    Germany
    Israel
    Italy
    Netherlands
    Poland
    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
    LA última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days21
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days21
    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: 8
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 3
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 5
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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
    Patient population newborn to < 6 months
    La población de estudio es en neonatos hasta menos de 6 meses
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 4
    F.4.2.2In the whole clinical trial 8
    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 cessation of study treatment with rivaroxaban, it is at the investigator?s discretion to continue with anticoagulation, as needed
    Después de la suspensión de rivaroxabán, corresponderá al investigador decidir según su criterio la continuación del tratamiento anticoagulante.
    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 Decision2015-04-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-12-18
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