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    Summary
    EudraCT Number:2010-024584-41
    Sponsor's Protocol Code Number:PR196/10
    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:2011-02-18
    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 number2010-024584-41
    A.3Full title of the trial
    Ensayo clínico, multicéntrico, aleatorio y controlado con placebo para evaluar la eficacia de la administración de concentrado de fibrinógeno sobre los requerimientos de derivados sanguíneos en la cirugía del trasplante hepático
    A.4.1Sponsor's protocol code numberPR196/10
    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 SponsorHospital Universitari de Bellvitge
    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 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 Haemocomplettan
    D.2.1.1.2Name of the Marketing Authorisation holderCSL Berhing
    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 nameFibrinogeno
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFibrinogeno
    D.3.9.3Other descriptive nameFibrinogeno
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    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) 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 Information not present in EudraCT
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    El trasplante hepático es una situación especial de riesgo de sangrado agudo y grave determinado por la complejidad del procedimiento quirúrgico y por la alteración de la hemostasia y coagulación presente en el paciente afecto de una hepatopatia terminal. La disminución de los valores de fibrinógeno en plasma durante la situación de sangrado se produce de manera aguda y superior a los otros factores que influyen en la hemostasia y coagulación.
    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
    Evaluar la eficacia de la administración de fibrinógeno manteniendo un nivel inmediatamente previo a la cirugía de trasplante hepático de fibrinógeno en plasma igual a 2,9 g/L comparado con placebo como adyuvante al tratamiento estándar de pacientes con cirugía de trasplante hepático, reflejándose por una reducción en el porcentaje de pacientes que requieren la transfusión de concentrados de hematíes intraoperatoriamente
    E.2.2Secondary objectives of the trial
    1. Evaluar la eficacia de la administración de fibrinógeno manteniendo un nivel inmediatamente previo a la cirugía de trasplante hepático de fibrinógeno en plasma igual a 2,9 g/L comparado con placebo como adyuvante al tratamiento estándar de pacientes con cirugía de trasplante hepático, reflejándose por una reducción en el porcentaje de pacientes que requieren derivados sanguíneos otros que los concentrados de hematíes (plasma fresco, fibrinógeno, plaquetas) durante el procedimiento

    2.- Determinar la influencia de la administración de fibrinógeno manteniendo un nivel inmediatamente previo a la cirugía de trasplante hepático de fibrinógeno en plasma igual a 2,9 g/L, en la mortalidad operatoria y en la supervivencia del injerto hepático valorada al año del procedimiento.
    3.- Determinar la seguridad de la administración de fibrinógeno mediante el registro de las complicaciones tromboticas de todo tipo y causa durante el ingreso hospitalario o un mínimo de 30 días del postoperatori
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a) Ser candidato a la realización de un trasplante ortotopico de hígado

    b) Tener un valor de plasmático de fibrinógeno inferior a 2,9 g/L en el periodo previo a la realización del trasplante, por o que se procederá a una determinación del fibrinógeno plasmático antes del procedimiento.
    E.4Principal exclusion criteria
    Pacientes con un valor de fibrinógeno en las 24 horas previas a la intervención superior a 2,9 g/L.
    . Historia conocida de acontecimientos tromboembólicos en los 30 días previos
    . Embarazo conocido o sospechado
    . Aleatorización anterior en este ensayo
    . Alergia conocida o sospechada al producto del ensayo o a los productos relacionados
    . Presencia conocida de trastorno hemorrágico congénito. Pacientes en tratamiento con aspirina, acenocumarol
    . Las siguientes indicaciones de trasplante: polineuropatía familiar, insuficiencia hepática aguda, cirrosis biliar y colangitis esclerosante
    . Donante a corazón parado y donante vivo
    . Paciente reacio a participar en el ensayo
    E.5 End points
    E.5.1Primary end point(s)
    - Porcentaje de pacientes que requieren la transfusión de concentrado de hematíes durante el procedimiento
    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 No
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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) No
    E.8.2.2Placebo Yes
    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 concerned3
    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
    Se efectuara un análisis interino una vez se hayan reclutado 80 pacientes, ya que la diferencia esperada entre el grupo intervención y el placebo en la reducción de la administración de concentrados de hematíes. La corrección de la multiplicidad y el error alfa deberá ser tenido en cuenta en el calculo del tamaño muestral, Las diferencias entre tratamientos deberán considerar un valor de la p inferior a 0,029 (Corrección de Pocock).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned 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.1.3Elderly (>=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 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 state132
    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 Decision2011-06-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2015-01-15
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