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    The EU Clinical Trials Register currently displays   44242   clinical trials with a EudraCT protocol, of which   7339   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2015-002610-76
    Sponsor's Protocol Code Number:39039039CHD3001/BAY59-7939-18226
    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:2016-08-05
    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 number2015-002610-76
    A.3Full title of the trial
    A Prospective, Open-Label, Active-Controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Rivaroxaban for Thromboprophylaxis in Pediatric Subjects 2 to 8 Years of Age after the Fontan Procedure
    Estudio prospectivo, abierto y controlado con medicación activa para evaluar la farmacocinética, la farmacodinamia, la seguridad y la eficacia de rivaroxabán para la tromboprofilaxis de niños de 2 a 8 años de edad después del procedimiento de Fontan
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Rivaroxaban for Thromboprophylaxis in Pediatric Subjects 2 to 8 Years of Age after the Fontan Procedure
    Estudio para evaluar la farmacocinética, la farmacodinamia, la seguridad y la eficacia de rivaroxabán para la tromboprofilaxis de niños de 2 a 8 años de edad después del procedimiento de Fontan
    A.4.1Sponsor's protocol code number39039039CHD3001/BAY59-7939-18226
    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 SponsorJanssen-Cilag International N.V
    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 supportJanssen Research & Development, LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen Cilag, S.A.
    B.5.2Functional name of contact pointGlobal Clinical Operations Spain
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de las Doce Estrellas, 5-7
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28042
    B.5.3.4CountrySpain
    B.5.4Telephone number34917228100
    B.5.5Fax number34917228628
    B.5.6E-mailagonza45@its.jnj.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 nameXarelto
    D.3.2Product code JNJ-39039039; BAY 59-7939
    D.3.4Pharmaceutical form Granules for oral solution
    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 codeJNJ-39039039; BAY 59-7939
    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.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 Aspirin
    D.2.1.1.2Name of the Marketing Authorisation holderactavis / Hexal
    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.3.1Product nameacetylsalicylic acid
    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 INNACETYLSALICYLIC ACID
    D.3.9.1CAS number 50-78-2
    D.3.9.4EV Substance CodeSUB12730MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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
    Thromboprophylaxis
    Tromboprofilaxis
    E.1.1.1Medical condition in easily understood language
    Thromboprophylaxis
    Tromboprofilaxis
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10040729
    E.1.2Term Single ventricle
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part A
    To characterize the single- and multiple-dose PK and PK/ PD profiles after oral rivaroxaban therapy administered to pediatric subjects 2 to 8 years of age with single ventricle physiology who have completed the Fontan procedure within 4 months prior to enrollment.

    Part B
    To evaluate the safety and efficacy of rivaroxaban, administered twice daily (exposure matched to rivaroxaban 10 mg once daily in adults) compared to ASA, given once daily (approximately 5 mg/kg) for thromboprophylaxis in pediatric subjects 2 to 8 years of age with single ventricle physiology who have completed the Fontan procedure within 4 months prior to enrollment.
    Parte A
    Caracterizar la farmacocinética (FC) de dosis única y dosis múltiples y los perfiles FC/farmacodinámicos (FD) después del tratamiento oral con rivaroxabán administrado a niños de 2 a 8 años de edad con fisiología de un solo ventrículo que se habían sometido al procedimiento de Fontan en los 4 meses previos a la inclusión.

    Parte B
    Evaluar la seguridad y la eficacia de rivaroxabán, administrado dos veces al día (exposición equiparable a rivaroxabán 10 mg una vez al día en adultos) en comparación con ácido acetilsalicílico (AAS), administrado una vez al día (alrededor de 5 mg/kg) para tromboprofilaxis en niños de 2 a 8 años de edad con fisiología de un solo ventrículo que se habían sometido al procedimiento de Fontan en los 4 meses previos a la inclusión.
    E.2.2Secondary objectives of the trial
    Part A
    To assess the safety and tolerability of rivaroxaban treatment.
    Part B
    To further characterize the PK and PK/PD profiles of rivaroxaban.
    Parte A
    Evaluar la seguridad y la tolerabilidad del tratamiento con rivaroxaban.
    Parte B
    Caracterizar mejor los perfiles FC y FC/FD de rivaroxaban.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Boys or girls 2 to 8 years of age with single ventricle physiology and who have completed the initial Fontan procedure within 4 months prior to enrollment
    2. Considered to be clinically stable by the investigator and able to tolerate oral or enteral administration of a suspension formulation and oral/enteral feedings
    3. Satisfactory initial post-Fontan transthoracic echocardiographic screening as defined in the Post-Fontan Echocardiographic Examination Research Protocol
    4. Parent/legally acceptable representative must sign an informed consent form (ICF) and child assent will also be provided, if applicable, according to local requirements.
    1. Niños o niñas de 2 a 8 años de edad con fisiología de un solo ventrículo que se hayan sometido al procedimiento inicial de Fontan en los 4 meses previos a la inscripción
    2. Considerados clínicamente estables por el investigador y capaces de tolerar la administración oral o enteral de una formulación en suspensión y alimentación oral/enteral
    3. Selección ecocardiográfica transtorácica inicial satisfactoria después del procedimiento de Fontan, tal como se define en el Post Fontan Echocardiographic Examination Research Protocol
    4. Uno de los progenitores o el representante legalmente aceptable deberán firmar un consentimiento informado (DCI), y también se obtendrá el asentimiento del niño, si procede, con arreglo a los requisitos locales
    E.4Principal exclusion criteria
    1. Evidence of thrombosis, including those that are asymptomatic confirmed by post-Fontan procedure transthoracic echocardiogram, or other imaging techniques, during the screening period of the study
    2. History of gastrointestinal disease or surgery associated with clinically relevant impaired absorption
    3. History of or signs/symptoms suggestive of protein-losing enteropathy
    4. Active bleeding or high risk for bleeding contraindicating antiplatelet or anticoagulant therapy, including a history of intracranial bleeding
    5. Indication for anticoagulant or antiplatelet therapy other than current study, however:
    - A subject who has received VKA after the Fontan procedure may be eligible provided that the subject has discontinued VKA before the screening visit. Baseline laboratory samples must be obtained at least 7 days after the last dose of VKA.
    - A subject who is receiving ASA at the time of the screening visit may be eligible and may continue on ASA provided the last dose is taken at least 24 hours prior to the first dose of study drug.
    6. Platelet count <50 x 10^9/L at screening.
    7. Creatinine clearance (CrCl) <30 mL/min/1.73m2.
    8. Known clinically significant liver disease.
    1. Signos de trombosis, incluidos los que sean asintomáticos y se confirmen en la ecocardiografía transtorácica posterior al procedimiento de Fontan, u otras técnicas de imagen, durante el periodo de selección del estudio
    2. Antecedentes de enfermedad o cirugía gastrointestinal asociada a una alteración clínicamente importante de la absorción
    3. Antecedentes de signos o síntomas reactivos de enteropatía con pérdida de proteínas
    4. Hemorragia activa o alto riesgo de hemorragia que contraindique el tratamiento con antiagregantes plaquetarios o anticoagulantes, incluidos los antecedentes de hemorragia intracraneal
    5. Indicación de tratamiento anticoagulante o antiagregante distinta de la del presente estudio, aunque:
    - Podrán participar los pacientes que hayan recibido un antagonista de la vitamina K (AVK) después del procedimiento de Fontan siempre que lo suspendan antes de la visita de selección. Se deben obtener muestras de laboratorio basales al menos 7 días después de la última dosis del AVK.
    - Los pacientes que estén recibiendo AAS en el momento de la visita de selección podrán participar y seguir utilizando AAS siempre que la última dosis se administre al menos 24 horas antes de la primera dosis de la medicación del estudio.
    6. Recuento de plaquetas < 50 x 109/l en la selección
    7. Aclaramiento de creatinina (CrCl) < 30 ml/min/1,73 m2
    8. Hepatopatía clínicamente importante confirmada
    E.5 End points
    E.5.1Primary end point(s)
    Part A:
    PK and PD Parameters: PT, aPTT and anti-FXa activity against Rivaroxaban plasma concentration.
    PK: AUC (O-24), Cmax after single dose and AUC (0-24), Cmax and Cmin at steady state

    Part B:
    Efficacy: Thrombotic events (venous or arterial), defined as:
    - The appearance of a new thrombotic burden within the cardiovascular system on either routine surveillance or clinically indicated imaging, or
    - The occurrence of a clinical event known to be strongly associated with thrombus (such as cardioembolic stroke, pulmonary embolism).
    Safety: major bleeding events as defined by ISTH
    Parte A
    Parámetros de FC y FD: (TP), (TTPa) y medición de la actividad anti-FXa contra la concentración plásmática de Rivaroxaban
    FC: AUC (0-24), (Cmax) después de una sola dósis y AUC (0-24), Cmax y Cmin en estado de equilibrio
    Parte B
    Eficacia: Episodios trombóticos (venoso o arterial) definido como:
    - Aparición de una nueva masa trombótica en el aparato cardiovascular en la vigilancia de rutina o en estudios de imagen clínicamente indicados, o
    - Aparición de un episodio clínico estrechamente relacionado con un trombo (como ictus cardioembólico o embolia pulmonar).
    Seguridad: episodio hemorrágico grave aplicando las recomendaciones de la ISTH
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part A:
    Day 1, 4, Month 3, Month 12

    Part B:
    Ongoing throughout the study as well as at pre-defined time points (Day 12, Months 3, 6 and 12) from enrollment until final follow-up phone call
    Parte A
    Día 1, 4, Mes 3, Mes 12

    Parte B
    A lo largo del estudio así como también en los momentos predefinidos (Día 12, meses 3, 6 y 12) desde la aleatorización hasta la llamada final de seguimiento
    E.5.2Secondary end point(s)
    Part A:
    Efficacy: Thrombotic events (venous or arterial), defined as:
    - The appearance of a new thrombotic burden within the cardiovascular system on either routine surveillance or clinically indicated imaging, or
    - The occurrence of a clinical event known to be strongly associated with thrombus (such as cardioembolic stroke, pulmonary embolism).
    Any death
    Safety: major bleeding events, Clinically relevant non-major bleeding events and trivial (minimal) bleeding as defined by ISTH; other adverse events and clinical laboratory test values (CBC, CrCl, liver function tests, and PT and aPTT).


    Part B:
    PK/PD Parameters: PT, aPTT and anti-FXa activity against Rivaroxaban plasma concentration.
    PK: AUC (O-24), Cmax after single dose and AUC (0-24), Cmax and Cmin at steady state
    Safety: Clinically relevant non-major bleeding events and trivial (minimal) bleeding as defined by ISTH; any death, other adverse events and clinical laboratory test values(CBC, CrCl, liver function tests, and PT and aPTT) .
    Parte A
    Efficacia: Episodios trombóticos (venoso o arterial) definido como:
    - Aparición de una nueva masa trombótica en el aparato cardiovascular en la vigilancia de rutina o en estudios de imagen clínicamente indicados, o
    - Aparición de un episodio clínico estrechamente relacionado con un trombo (como ictus cardioembólico o embolia pulmonar).
    Cualquier muerte.
    Seguridad: episodio hemorrágico grave, acontecimientos hemorrágicos no graves clínicamente relevantes y las hemorragias triviales (mínimas) aplicando las recomendaciones de la ISTH, cualquier muerte, otros acontecimientos adversos y valores de pruebas de laboratorio (CBC, CrCl, pruebas de función hepática, TP, TTPa)
    Parte B:
    Parámetros de FC y FD: TP, TTPa y medición de la actividad anti-FXa contra la concentración plásmática de Rivaroxaban
    FC: AUC (0-24), Cmax después de una sola dósis y AUC (0-24), Cmax y Cmin en estado de equilibrio
    Seguridad: acontecimientos hemorrágicos no graves clínicamente relevantes y las hemorragias triviales (mínimas) aplicando las recomendaciones de la ISTH, cualquier muerte, otros acontecimientos adversos y valores de priebas de laboratorio (CBC, CrCl, pruebas de función hepática, TP, TTPa)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Part A:
    Ongoing throughout the study as well as at pre-defined time points (Day 12, Months 3, 6 and 12) from enrollment until final follow-up examination

    Part B:
    Day 1, Month 3, Month 12
    Parte A
    A lo largo del estudio así como también en los momentos predefinidos (Día 12, meses 3, 6 y 12) desde la aleatorización hasta la llamada final de seguimiento

    Parte B
    Día 1, Mes 3, Mes 12
    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) 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 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) 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    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
    Belgium
    Brazil
    Canada
    China
    France
    Japan
    Korea, Republic of
    Malaysia
    Mexico
    Netherlands
    Spain
    Thailand
    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
    The study is considered completed with the last scheduled study contact shown in the Time and Events Schedule for the last subject participating in the study.
    El estudio se considera completado con la última visita programada en el calendario de tiempos y eventos del ensayo del último sujeto participante en el estudio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days6
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days6
    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: 100
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 100
    F.1.1.6Adolescents (12-17 years) No
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 25
    F.4.2.2In the whole clinical trial 100
    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)
    Not applicable
    No aplicable
    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 Decision2016-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-09
    P. End of Trial
    P.End of Trial StatusCompleted
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