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    Summary
    EudraCT Number:2014-000583-18
    Sponsor's Protocol Code Number:1160.108
    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:2014-05-28
    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 number2014-000583-18
    A.3Full title of the trial
    Open label, single arm safety prospective cohort study of dabigatran etexilate for secondary prevention of venous thromboembolism in children from 0 to less than 18 years
    Estudio abierto, de cohortes, prospectivo de seguridad y de un único grupo de dabigatrán etexilato para la prevención secundaria del tromboembolismo venoso en niños desde 0 años hasta menos de 18 años.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety of dabigatran etexilate in blood clot prevention in children
    Seguridad de dabigatrán etexilato en la prevención de la formación de coágulos sanguíneos en niños
    A.4.1Sponsor's protocol code number1160.108
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/007/2014
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBoehringer Ingelheim España, S.A.
    B.1.3.4CountrySpain
    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 supportboehringer Ingelheim España, S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBoehringer Ingelheim Pharma GmbH & Co. KG
    B.5.2Functional name of contact pointQRPE pSC CT Information Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressBinger Strasse 173
    B.5.3.2Town/ cityIngelheim am Rhein
    B.5.3.3Post code55216
    B.5.3.4CountryGermany
    B.5.4Telephone number+18002430127
    B.5.5Fax number+18008217119
    B.5.6E-mailclintriage.rdg@boehringer-ingelheim.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 namedabigatran etexilate, 50 mg
    D.3.2Product code BIBR 1048 MS
    D.3.4Pharmaceutical form Capsule, hard
    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 INNDABIGATRAN ETEXILATE
    D.3.9.2Current sponsor codeBIBR 1048 MS
    D.3.9.4EV Substance CodeSUB20521
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Pradaxa
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    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 namedabigatran etexilate, 75 mg
    D.3.2Product code BIBR 1048 MS
    D.3.4Pharmaceutical form Capsule, hard
    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 INNDABIGATRAN ETEXILATE
    D.3.9.2Current sponsor codeBIBR 1048 MS
    D.3.9.4EV Substance CodeSUB20521
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 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 Pradaxa
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    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 namedabigatran etexilate, 110 mg
    D.3.2Product code BIBR 1048 MS
    D.3.4Pharmaceutical form Capsule, hard
    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 INNDABIGATRAN ETEXILATE
    D.3.9.2Current sponsor codeBIBR 1048 MS
    D.3.9.4EV Substance CodeSUB20521
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number110
    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
    Secondary prevention of venous thromboembolism
    Prevención secundaria de la tromboembolia venosa
    E.1.1.1Medical condition in easily understood language
    Prevention of blood clots in the veins
    Prevención de la formación de coágulos sanguíneos en las venas
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10049909
    E.1.2Term Venous thromboembolism prophylaxis
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety of dabigatran etexilate used for secondary prevention of venous thromboembolism in children from 0 to less than 18 years of age.
    Evaluar la seguridad de dabigatrán etexilato utilizado para la prevención secundaria de la tromboembolia venosa en niños de 0 a menos de 18 años de edad.
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female subjects 0 to less than 18 years of age at the time of informed consent / assent
    - Previously documented objective diagnosis of VTE, followed by completed course of initial VTE treatment (for at least 3 months) or completed study treatment (i.e. reached Visit 8) in the 1160.106 trial
    - Presence of an unresolved clinical risk factor requiring further anticoagulation for secondary VTE prevention (e.g. central venous line, underlying disease, thrombophilia, etc.)
    - Written informed consent form (ICF) provided by the patient's parent or legal guardian and assent provided by the patient (if applicable) at the time of ICF signature according to local regulations.
    1.Pacientes de ambos sexos de 0 a menos de 18 años de edad en el momento del consentimiento/asentimiento informado.
    2.Diagnóstico objetivo documentado previamente de VTE, seguido de un ciclo completo de tratamiento inicial para la VTE (durante un mínimo de 3 meses) o tratamiento del estudio completado (es decir, haber llegado a la visita 8) en el ensayo 1160.106
    3.Presencia de un factor de riesgo clínico no resuelto que requiere tratamiento anticoagulante adicional para la prevención secundaria de la VTE (p. ej., vía venosa central, enfermedad subyacente, trombofilia, etc.).
    4.Consentimiento informado por escrito proporcionado por el progenitor o tutor legal del paciente y asentimiento del paciente (si procede) en el momento de la firma del ICF, según la normativa local.
    E.4Principal exclusion criteria
    - Conditions associated with an increased risk of bleeding
    - Renal dysfunction (eGFR < 80 mL/min/1.73m2 using the Schwartz formula) or requirement for dialysis
    - Active infective endocarditis
    - Subjects with a mechanical or a biological heart valve prosthesis
    - Hepatic disease: Active liver disease, including known hepatitis A, B or C or Persistent alanine aminotransferase (ALT) or aspartate transaminase (AST) or alkaline phosphatase (AP) > 2 × upper limit of normal (ULN) within 3 months of screening
    - Pregnant or breast feeding females. Females who have reached menarche and are not using an acceptable method of birth control, or do not plan to continue using this method throughout the study and / or do not agree to adhere to pregnancy testing required by this protocol
    - Anemia (hemoglobin < 80g/L) or thrombocytopenia (platelet count < 80 x 109/L) at screening. Transfusions during the screening period are allowed, provided that a satisfactory hemoglobin or platelet level is attained prior to visit 2
    - Patients who have taken restricted medication prior to first dose of study medication
    - Patients who have received an investigational drug in the past 30 days prior to screening, except patients who have completed the treatment period (up to Visit 8) in 1160.106 trial
    - Patients who are allergic/sensitive to any component of the study medication including solvent
    - Patients or parents/legal guardians considered unreliable to participate in the trial per investigator judgment or any condition which would present a safety hazard to the patient based on investigator judgment
    1.Patologías asociadas a un riesgo alto de hemorragia:
    2.Insuficiencia renal (eGFR < 80 ml/min/1,73 m2 usando la fórmula de Schwartz) o necesidad de diálisis.
    3.Endocarditis infecciosa activa
    4.Pacientes con una prótesis valvular cardíaca mecánica o biológica.
    5.Enfermedad hepática:
    a.Enfermedad hepática activa, incluida hepatitis A, B o C diagnosticada o,
    b.Niveles persistentes de alanina-aminotransferasa (ALT), aspartato-transaminasa (AST) o fosfatasa alcalina (AP) > 2 veces el límite superior de la normalidad (ULN) dentro de los 3 meses de la selección.
    6.Mujeres embarazadas o en periodo de lactancia. Mujeres que hayan llegado a la menarquia y no utilicen un método anticonceptivo aceptable o no tienen intención de continuar utilizando este método durante todo el estudio y no acceden a someterse a la prueba de embarazo exigida en este protocolo.
    7.Anemia (hemoglobina < 80 g/l) o trombocitopenia (cifra de plaquetas < 80 x 109/l) en la selección. Las transfusiones están permitidas durante el periodo de selección, pero sólo si se ha alcanzado un nivel de hemoglobina o plaquetas satisfactorio antes de la visita 2.
    8.Pacientes que hayan recibido medicación prohibida antes de la primera dosis de la medicación del estudio.
    9.Pacientes que hayan recibido un fármaco en investigación en los 30 días previos a la selección, excepto los pacientes que hayan completado el periodo de tratamiento (hasta la visita 8) en el estudio 1160.106.
    10.Pacientes alérgicos/sensibles a cualquiera de los componentes de la medicación del estudio, incluido el disolvente.
    11.Pacientes o padres/tutores legales a los que el investigador no considere aptos para participar en el estudio, o cualquier enfermedad que pudiera poner en peligro la seguridad del paciente, según el criterio del investigador.
    E.5 End points
    E.5.1Primary end point(s)
    1: Recurrence of venous thromboembolism (VTE)

    2: Major and minor (including clinically relevant non-major (CRNM)) bleeding events

    3: Mortality overall and related to thrombotic or thromboembolic events
    1: Recurrencia de la tromboembolia venosa (VTE)
    2: Acontecimientos hemorrágicos graves y leves, incluida la hemorragia no grave clínicamente relevante (CRNM)
    3: Mortalidad global y relacionada con acontecimientos trombóticos o tromboembólicos
    E.5.1.1Timepoint(s) of evaluation of this end point
    1: 6 and 12 months

    2: 6 and 12 months

    3: 6 and 12 months
    1: 6 y 12 meses

    2: 6 y 12 meses

    3: 6 y 12 meses
    E.5.2Secondary end point(s)
    1: Occurrence of post-thrombotic syndrome (PTS)

    2: Central measurement of aPTT (Activated partial thromboplastin time)

    3: Central measurement of ECT (Ecarin clotting time )

    4: Number of dabigatran etexilate dose adjustments during treatment period
    1: Aparición de síndrome postrombótico (PTS)
    2: Determinación central de aPTT (tiempo parcial de tromboplastina activada)
    3: Determinación central de ECT (tiempo de coagulación de Ecarin)
    4: Número de ajustes de dosis de dabigatrán etexilato durante el periodo de tratamiento
    E.5.2.1Timepoint(s) of evaluation of this end point
    1: 6 and 12 months

    2: after 3 weeks of treatment

    3: after 3 weeks of treatment

    4: 12 months
    1: 6 y 12 meses

    2: después de 3 semanas de tratamiento

    3: después de 3 semanas de tratamiento

    4: 12 meses
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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
    Austria
    Belgium
    Brazil
    Bulgaria
    Canada
    Colombia
    Czech Republic
    Finland
    France
    Germany
    Greece
    Israel
    Italy
    Lithuania
    Mexico
    Norway
    Russian Federation
    Slovakia
    Spain
    Sweden
    Switzerland
    Taiwan
    Thailand
    Turkey
    Ukraine
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    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 months9
    E.8.9.1In the Member State concerned days26
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days26
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 10
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 30
    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 Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    paediatric patients
    pacientes pediátricos
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 49
    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)
    At the end of the study all patients need to discontinue dabigatran etexilate, or switch to standard of care, if there is continued need for anticoagulant treatment.
    Al final del estudio todos los pacientes deberán suspender el tratamiento con dabigatrán etexilato, o cambiar al tratamiento de referencia, si existe una necesidad continua de 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 Decision2014-07-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-07-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-11-19
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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