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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:2008-006887-12
    Sponsor's Protocol Code Number:HEPACO
    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:2011-09-15
    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 number2008-006887-12
    A.3Full title of the trial
    Randomized controlled trial to compare treatment with oral anticoagulation with vitamin K antagonists versus low molecular weight heparin (bemiparin) in patients with anticoagulation criteria and have an episode of gastrointestinal bleeding.
    ESTUDIO RANDOMIZADO Y CONTROLADO PARA COMPARAR EL TRATAMIENTO CON ANTICOAGULACIÓN ORAL CON ANTAGONISTAS DE LA VITAMINA K VERSUS HEPARINA DE BAJO PESO MOLECULAR (BEMIPARINA) EN PACIENTES CON CRITERIOS DE ANTICOAGULACIÓN Y QUE HAN PRESENTADO UN EPISODIO DE HEMORRAGIA DIGESTIVA.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study comparing two anticoagulation drucgs, bemiparin and warfarin, in patients who have had gastrointestinal bleeding and need for his illness to be anticoagulated
    Estudio para comparar dos tratamiento anticoagulantes, bemiparina y warfarina, en pacientes que ya han tenido una hemorragia digestiva y que necesitan por su enfermedad estar anticoagulados.
    A.3.2Name or abbreviated title of the trial where available
    HEPACO
    A.4.1Sponsor's protocol code numberHEPACO
    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 SponsorInstitut de Recerca HSCSP
    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 supportSpain health authorities
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut de Recerca HSCSP
    B.5.2Functional name of contact pointRomy Rodríguez
    B.5.3 Address:
    B.5.3.1Street AddressC. Sant Antoni Maria Claret, 167
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08025
    B.5.3.4CountrySpain
    B.5.4Telephone number003429190001969
    B.5.5Fax number00345537812
    B.5.6E-mailRRodriguezMu@santpau.cat
    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 7.500 UI
    D.2.1.1.2Name of the Marketing Authorisation holderLABORATORIOS FARMACEUTICOS ROVI, S.A.
    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.3.4Pharmaceutical 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 INNBEMIPARINA SODICA
    D.3.9.3Other descriptive nameBEMIPARINA SODICA
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number10.000
    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 Aldocumar
    D.2.1.1.2Name of the Marketing Authorisation holderAldo Union
    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.3.4Pharmaceutical 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 INNwarfarina
    D.3.9.1CAS number 152-72-7
    D.3.9.3Other descriptive namewarfarina sodica
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number10
    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
    Patients with gastrointestinal bleeding are not candidates for endoscopic treatment with oral anticoagulant previously.
    Los pacientes con hemorragia digestiva no candidatos a tratamiento endoscópico y en tratamiento con anticoagulantes orales previamente.
    E.1.1.1Medical condition in easily understood language
    Patients treated with oral antociagulantes, have had a gastrointestinal bleeding.
    Los pacientes en tratamiento con antociagulantes orales y que presenten un sangrado digestivo.
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    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 assess whether the substitution therapy with vitamin K antagonists by molecular-weight heparin (bemiparin) in patients who have had an episode of gastrointestinal bleeding and who have indications for anticoagulation is associated with a decreased incidence of recurrent gastrointestinal bleeding.
    Evaluar si la sustitución del tratamiento con antagonista de la vitamina K por heparina de bajo peso molecular (bemiparina), en pacientes que hayan presentado un episodio de hemorragia digestiva y que tengan indicación de tratamiento anticoagulante, se asocia a una disminución en la incidencia de recidiva de hemorragia digestiva.
    E.2.2Secondary objectives of the trial
    - Incidencia de episodios tromboembólicos
    - Hemorragias en otras localizaciones
    - Severidad de los episodios de recurrencia hemorrágica
    - Necesidades transfusionales
    - Identificación de factores de riesgo asociados
    - Mortalidad
    - Incidence of thromboembolic episodes
    - Bleeding from other locations
    - Severity of episodes of recurrent bleeding
    - Need for transfusion
    - Identification of risk factors associated
    - mortality
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with anticoagulant therapy criteria (acenocoumarol or warfarin-treated) and high or very high risk embolism, which have had an acute gastrointestinal bleeding (low or high) not amenable to endoscopic treatment, vascular lesions secondary to multiple diverticular origin, or with not clear origen (after gastroscopy and colonoscopy) that have no exclusion criteria.
    Pacientes con criterios de tratamiento anticoagulante (tratados con acenocumarol o warfarina) y con alto o muy alto riesgo embolígeno, que presentan una hemorragia digestiva aguda (alta o baja) no susceptible a tratamiento endoscópico, secundaria a lesiones vasculares múltiples, de origen diverticular, o bien de origen no aclarado (tras realización de una gastroscopia y una colonoscopia) que no tengan ningún criterio de exclusión.
    E.4Principal exclusion criteria
    A) under 18 years.
    B) pregnancy.
    C) patient refusal to participate in the study.
    D) patients who took the decision not to provide active treatment for the existence of any clinical condition considered terminal (severe associated diseases evolved).
    E) LMWH contraindication (allergy, heparin-induced thrombocytopenia).
    F) bleeding secondary to esophageal varices and / or gastric ulcers.
    G) bleeding associated with peptic injury.
    H) bleeding secondary to tumors or polyps.
    i) Presence of portal hypertension with or without liver cirrhosis.
    J) bleeding due to Mallory-Weiss syndrome.
    K) anticoagulation low risk for injury embolism.
    A) edad inferior a 18 años.
    B) embarazo.
    C) negativa del paciente para participar en el estudio.
    D) pacientes en los que se haya adoptado la decisión de no proporcionar ningún tratamiento activo por la existencia de alguna situación clínica considerada terminal (enfermedades asociadas graves evolucionadas).
    E) Contraindicación HBPM (alergia, trombocitopenia inducida por heparina).
    F) Hemorragias secundarias a varices esofágicas y/o gástricas.
    G) Hemorragias asociadas a lesiones pépticas.
    H) Hemorragias secundarias a neoplasias o pólipos.
    i) Presencia de hipertensión portal con o sin cirrosis hepática.
    J) Hemorragias debidas a síndrome de Mallory-Weiss.
    K) Descoagulación por lesiones de bajo riesgo embolígeno.
    E.5 End points
    E.5.1Primary end point(s)
    Digestive bleeding incidence
    Incidencia hemorragia digestiva.
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 years
    2 años
    E.5.2Secondary end point(s)
    - Mortality
    - Severity of the recurrence
    - Incidence tromboembolism
    - Asotiation with AINEs, aspirin AAs or other antiagregants.
    - Complications of treatment
    - Mortalidad
    - Gravedad de la recidiva
    - Incidencia de episodios tromboembólicos
    - Asociación con AINEs, aspirina AAs u otros antiagregantes.
    - Complicaciones del tratamiento
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 years
    2 años
    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 Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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 Yes
    E.8.2.3.1Comparator description
    bemiparina vs warfarina
    bemiparina vs warfarina
    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 Information not present in EudraCT
    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
    When it is required by the patient or by investigator decision.
    Cuando sea requerido por el paciente o cuando sea decisión del investigador.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    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)
    Se proporcionará el tratamiento habitual para el tipo de pacientes del estudio.
    Se proporcionará el tratamiento habitual para el tipo de pacientes del estudio.
    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 Decision2011-12-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-27
    P. End of Trial
    P.End of Trial StatusCompleted
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