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    Summary
    EudraCT Number:2015-003866-96
    Sponsor's Protocol Code Number:BEMI-2015
    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:2016-02-03
    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 number2015-003866-96
    A.3Full title of the trial
    Randomized controlled trial on the safety and efficacy of low molecular weight heparins in the prevention of thrombotic events in hospitalized cirrhotic patients
    Estudio controlado y aleatorizado sobre la seguridad y eficacia del uso de heparinas de bajo peso molecular en la prevención de episodios trombóticos en pacientes cirróticos hospitalizados
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial about the prevention of thrombosis in hospitalized cirrhotic patients
    Ensayo sobre la prevención de la trombosis en pacientes cirróticos hospitalizados
    A.3.2Name or abbreviated title of the trial where available
    BEMI 2015
    BEMI 2015
    A.4.1Sponsor's protocol code numberBEMI-2015
    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 SponsorANGELA PUENTE
    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 supportLABORATORIOS ROVI
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationANGELA PUENTE
    B.5.2Functional name of contact pointANGELA
    B.5.3 Address:
    B.5.3.1Street AddressAV. VALDECILLA SN
    B.5.3.2Town/ citySANTANDER
    B.5.3.3Post code39008
    B.5.3.4CountrySpain
    B.5.4Telephone number00349422025202929
    B.5.5Fax number0034942202544
    B.5.6E-mailanpuente@humv.es
    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 Yes
    D.2.1.1.1Trade name HIBOR 3500 UI
    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 3500 UI
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    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 INNBEMIPARIN SODIUM
    D.3.9.1CAS number 9041-08-1
    D.3.9.4EV Substance CodeSUB20549
    D.3.10 Strength
    D.3.10.1Concentration unit ATU anti-thrombin unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.500
    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) 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
    Prevention of thrombosis in cirrhotic patients
    Prevención de la trombosis en pacientes cirróticos
    E.1.1.1Medical condition in easily understood language
    Prevention of thrombosis in cirrhotic patients
    Prevención de la trombosis en pacientes cirróticos
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level HLGT
    E.1.2Classification code 10014523
    E.1.2Term Embolism and thrombosis
    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
    To assess the safety and efficacy of prophylactic anticoagulation for the prevention of thrombotic events in hospitalized cirrhotic patients
    Evaluar la seguridad y eficacia de la anticoagulación profiláctica para la prevención de eventos tombóticos en pacientes cirróticos hospitalizados
    E.2.2Secondary objectives of the trial
    1.To assess prospectively the incidence of thrombotic events in hospitalized
    cirrhotic patients. 2. To assess the efficacy of low molecular weight heparin (HIBOR
    3.500UI) in preventing thrombotic events in cirrhotic patients hospitalized. 3. To
    Identify risk factors for development of portal vein thrombosis and deep vein
    thrombosis in hospitalized patients. 4.To evaluate related morbidity and mortality
    thromboembolic events. 5. To Assess prophylactic anticoagulation levels by
    determining antiXa and antithrombin III. 6. To study the expression profile and
    functionality of the family of Toll-like receptors, I-FABP / IL6-IL8 / NO, endothelin
    and LPS-binding protein. 7. To evaluate the effect on liver fibrosis (by FibroScan®)
    and serum TGFB 8. To study the hepatocellular function estimated by the
    Child-Pugh scores and MELD
    1.Evaluar de forma prospectiva la incidencia de fenómenos trombóticos en
    pacientes cirróticos hospitalizados. 2.Evaluar la eficacia del uso de heparina de
    bajo peso molecular (HIBOR 3.500UI) en la prevención de eventos trombóticos en
    pacientes cirróticos hospitalizados. 3.Identificar factores de riesgo de desarrollo de
    trombosis portal y trombosis venosa profunda en pacientes hospitalizados.
    4.Evaluar la morbimortalidad relacionada con los fenómenos tromboembólicos.
    5.Evaluar los niveles de anticoagulación profiláctica mediante la determinación de
    antiXa y antitrombina III. 6.Estudiar el perfil de expresión y funcionalidad de la
    familia de receptores de tipo Toll, I-FABP/IL6-IL8/NO, endotelina y LPS-binding
    protein. 7.Evaluar el efecto sobre la fibrosis hepática (mediante Fibroscan® ) y
    TGF? sérico 8.Evolución de la función hepatocelular estimada mediante los scores
    de Child-Pugh y MELD
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Applicants must meet all the following: 1) Liver cirrhosis of any etiology diagnosed
    by biopsy or after clinical, laboratory and ultrasound criteria; 2) Admission to
    hospital more than 3 days of their liver decompensation (ascites, encephalopathy,
    upper gastrointestinal bleeding or low controlled, spontaneous bacterial peritonitis)
    3) signed written consent.4) women in childbearing age with use of effective
    contraception
    Se deberán cumplir todos los siguientes: 1) Cirrosis hepática de cualquier etiología
    diagnosticada por biopsia previa o por criterios clínicos, analíticos y ecográficos; 2) Ingreso hospitalario superior a 3 días por descompensación de su hepatopatía
    (ascitis, encefalopatía, hemorragia digestiva alta o baja controlada, peritonitis
    bacteriana espontánea) 3) Consentimiento firmado por escrito, 4)Mujeres en edad
    fértil con uso de método anticonceptivo eficaz
    E.4Principal exclusion criteria
    One or more of the following: 1) Age <18 and> 80 years; 2) contraindication to
    heparin treatment of low molecular weight, 3) uncontrolled bleeding 4) Any
    comorbidity involving a therapeutic limitation and / or a life expectancy <6 months;
    5) concomitant antiplatelet therapy (aspirin, clopidogrel, ticlopidine, dipyridamole,
    sulfinpyrazone, dextran 40, or other anticoagulants 6) and continued concomitant
    NSAIDs, salicylates, corticosteroids; 7) existence of clinically significant esophageal
    varices / severe gastropathy of portal hypertension without their having been
    previously treated with primary / secondary prophylaxis (endoscopic variceal ligation
    / non-cardioselective beta-blockers); 8) refusal to participate in the study or to sign
    the informed consent; 9) Pregnancy and lactation; 10) HIV infection; 11) severe
    thrombocytopenia <20,000 platelets / dl, 12) Failure to severe with lower clearance
    30ml / min Renal 13) portal vein thrombosis or peripheral thrombosis diagnosed on
    admission, 14) Presence of previously known procoagulant factor
    Uno o más de los siguientes: 1) Edad <18 y >80 años; 2) contraindicación a
    tratamiento heparinas de bajo peso molecular, 3) Hemorragia no controlada 4)
    Cualquier comorbilidad que conlleve una limitación terapéutica y/o un pronóstico de
    vida <6 meses; 5) tratamiento concomitante con antiagregantes (ácido
    acetilsalicilico, clopidogrel, ticlopidina, dipiridamol, sulfinpirazona, dextrano 40, u
    otros anticoagulantes 6) tratamiento concomitante y continuado de antiinflamatorios
    no esteroideos, salicilatos, corticoides; 7) existencia de Varices esofágicas
    clínicamente significativas/ gastropatía severa de la Hipertensión portal sin que
    hayan sido tratatadas previamente con profilaxis primaria/secundaria (Ligadura
    endoscópica de varices/ betabloqueantes no cardioselectivos) ; 8) Negativa a
    participar en el estudio, o afirmar el consentimiento informado; 9) Embarazo o
    lactancia; 10) Infección por el VIH; 11) plaquetopenia severa < 20.000 plaquetas/dl,
    12) Insuficiencia Renal grave con aclaramiento inferior a 30ml/min, 13) Trombosis
    portal o TVP diagnosticadas al ingreso, 14) Presencia de factor procoagulante
    previamente conocido.
    E.5 End points
    E.5.1Primary end point(s)
    Security prophylactic anticoagulation with Bemiparin (HIBOR®) for the prevention of
    vein thrombosis in patients with prolonged hospitalization
    Seguridad de la anticoagulación profiláctica con Bemiparina (HIBOR®) para la
    prevención de la trombosis venosa profunda/ trombosis portal en pacientes
    cirróticos con hospitalización prolongada
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months
    3 meses
    E.5.2Secondary end point(s)
    Related peripheral and portal thrombosis
    Aparición de trombosis portal o perfiferica
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 months
    3 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 Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    ningún procedimiento
    non procedure
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 No
    E.8.7Trial has a data monitoring committee No
    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
    ULTIMA VISITA DEL ULTIMO PACIENTE
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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.1.2.1Number of subjects for this age range: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state225
    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)
    None
    Ninguno
    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 Decision2016-04-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-02-01
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