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    The EU Clinical Trials Register currently displays   43925   clinical trials with a EudraCT protocol, of which   7306   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:2006-001862-17
    Sponsor's Protocol Code Number:ACO-BEMI-01-2006
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2010-03-11
    Trial 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 number2006-001862-17
    A.3Full title of the trial
    Ensayo clínico, multicéntrico, aleatorizado, controlado y doble ciego, para el estudio de la terapia puente con bemiparina sódica frente a heparina cálcica no fraccionada en procedimientos invasivos ambulatorios, en cirugía ambulatoria y en cirugía general laparoscópica en pacientes bajo tratamiento con anticoagulante oral
    A.3.2Name or abbreviated title of the trial where available
    BERTA
    A.4.1Sponsor's protocol code numberACO-BEMI-01-2006
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorInstitut de Recerca de l'Hospital de la Santa Creu i Sant Pau
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    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 Heparina cálcica
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameheparina cálcica
    D.3.4Pharmaceutical form Injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHEPARINA CALCICA
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 HIBOR
    D.2.1.1.2Name of the Marketing Authorisation holderLABORATORIOS FARMACEUTICOS ROVI SA.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameHIBOR
    D.3.4Pharmaceutical form Injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHEPARINA DE BAJO PESO MOLECULAR
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection*
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prevención de la enfermedad tromboembólica en pacientes sometidos a cirurgía general con riesgo moderado o a cirurgía ortopédica. Profilaxis de la trombosis venosa profunda en pacientes no quirúrgicos con riesgo elevado o moderado.
    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
    Como objetivo principal del estudio se considerará la eficacia del tratamiento. Se empleará como variable principal de eficacia la ocurrencia de eventos tromboembólicos.
    Asimismo, y siguiendo las recomendaciones de la EMEA, se considerará también como objetivo principal del estudio la ocurrencia de fallecimientos en ambos brazos de tratamiento.
    E.2.2Secondary objectives of the trial
    Como objetivo secundario del estudio se valorará la seguridad del tratamiento con Bemiparina como terapia puente sustitutiva de la anticoagulación oral frente a la Heparina Cálcica. Así la seguridad del tratamiento será evaluada en función de las ocurrencias de hemorragias mayores, de trombocitopenias severas y de otros acontecimientos adversos presentados por los pacientes durante el estudio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. - Pacientes con edades comprendidas entre los 18 y los 80 años, que hayan otorgado su consentimiento informado para participar en el estudio, que estén en tratamiento anticoagulante oral y vayan a ser sometidos a procedimientos invasivos ambulatorios, a cirugía menor ambulatoria o a cirugía general de corta estancia definiéndose estos procesos como sigue:

    Cirugía Menor Ambulatoria: Comprende todos aquellos procedimientos quirúrgicos o pruebas exploratorias diagnósticas de mayor o menor complejidad en las que, independientemente del tipo de anestesia que se haya realizado, y tras un periodo variable de tiempo, los pacientes vuelven a su casa el mismo día de la intervención.
    • Fibrocolonoscopia
    • Fibroendoscopia
    • Biopsias y PAAF.
    • Infiltraciones articulares
    • Artrocentesis
    • Broncoscopia
    • Coronariografía
    • Cirugía ocular que requiera anestesia retrobulbar.
    • Artroscopia
    • Recambio de batería de marcapasos.
    • Cistoscopia
    • Biopsia de próstata

    Procedimientos intrahospitalarios de corta estancia:
    Cirugía General:
    • Hernorrafía.
    • Apendicectomía.
    • Cirugía laparoscópica: Colecistectomía, apendicectomía, u otras.
    E.4Principal exclusion criteria
    1. - Pacientes con insuficiencia hepática (con valores de AST y/o ALT > 5 veces el valor normal establecido en los rangos de referencia del laboratorio local del hospital), insuficiencia renal grave (creatinina sérica superior a 2 mg/dl), o aclaramiento renal <30%.
    2. Pacientes que hayan presentado fenómenos tromboembólicos estando bien anticoagulados , es decir con INR correcto.
    3. Pacientes con hipersensbilidad a bemiparina sódica, heparina o sustancias de origen porcino.
    4. Pacientes con lesiones orgánicas susceptibles de sangrar (úlcera péptica activa, accidente cerebrovascular hemorrágico, aneurismas).
    5. Antecedentes o sospecha de trombocitopenia asociada a heparina.
    6. Pacientes a los que por cualquier causa no se pueda realizar el seguimiento.
    7. Pacientes que estén participando en otro ensayo clínico o lo hayan hecho en los últimos 30 días.
    8. Pacientes con déficit de antitrombina, proteína C y S,
    9. Mujeres embarazadas o en edad fértil que no utilicen un método anticonceptivo eficaz o mujeres en periodo de lactancia.
    10. Endocarditis bacteriana aguda y endocarditis lenta.
    11. Hipertensión arterial grave (presión arterial sistólica mayor de 200 mmHg y/o presión arterial diastólica mayor de 120 mmHg)


    E.5 End points
    E.5.1Primary end point(s)
    Variable principal de eficacia

    La variable principal de eficacia será valorada en función de la tasa de incidencia de complicaciones tromboembólicas confirmadas por métodos objetivos.
    Se definirá la incidencia de complicaciones tromboembólicas como:
    1. Trombosis venosa profunda en cualquier localización y tromboembolismo pulmonar diagnosticados por métodos objetivos:
    Trombosis Venosa Profunda:
    Flebografía
    Plestimografía de Impedancia
    Ecografía Venosa de Compresión
    Embolia Pulmonar:
    Arteriografía
    Gammagrafía Pulmonar
    Tomografía Computarizada (TC) Helicoidal
    2. Accidente cerebrovascular isquémico establecido de probable origen tromboembólico diagnosticado por:
    Tomografía Computarizada
    Resonancia Magnética
    Angiografía
    ECO-Doppler
    Fonoangiografía Carótida
    3. Trombosis de la prótesis mecánica o presencia de trombo en cavidades cardíacas diagnosticado por ecocardiograma tranesofágico o transtorácico.
    4. Accidente isquémico periférico de probable origen tromboembólico diagnosticado por arteriografía.
    5. Accidente cerebrovascular isquémico transitorio de probable origen tromboembólico, diagnosticado por clínica por un neurólogo y por TC, RM, Angiografía. ECO-Doppler o Fonoangiografía Carótida.
    6. Síndrome coronario agudo tipo infarto de miocardio diagnosticado por electrocardiograma y valoración de la troponina.

    Variable principal de seguridad

    Como variable principal de seguridad se incluirá la incidencia de complicaciones hemorrágicas mayores que se produzcan durante la administración del tratamiento del estudio o en las 48 horas posteriores a la administración de la última dosis.
    Se definirá hemorragia mayor como:

    1. Hemorragia con desenlace fatal
    2. Hemorragia clínicamente evidente asociada a una caída de Hb de 20 g/l o mayor.
    3. Hemorragia clínicamente evidente que requiera transfusión de 2 o más unidades de hematíes.
    4. Hemorragia que suponga la interrupción del tratamiento a estudio.
    5. Hemorragia que suponga reintervención quirúrgica o el ingreso del paciente.
    6. Hemorragia sintomática en un área u órgano crítico como intracraneal, intraespinal, retroperitoneal o sangrado pericárdico.
    En el CRD deberá especificarse si la hemorragia mayor se produjo como consecuencia directa del procedimiento invasivo o intervención quirúrgica o si por el contrario tuvo lugar por otra causa y en otra localización.
    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 Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 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 concerned20
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state2082
    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 Decision2006-12-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-10-11
    P. End of Trial
    P.End of Trial StatusOngoing
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