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    Summary
    EudraCT Number:2008-006324-62
    Sponsor's Protocol Code Number:NN1810-3540
    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:2009-03-26
    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 number2008-006324-62
    A.3Full title of the trial
    Ensayo multicéntrico, aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia y la seguridad de la reposición de FXIII con dos dosis diferentes de factor XIII recombinante tras cirugía de derivación cardiopulmonar


    A Multi-Centre, Randomised, Double-Blind, Placebo Controlled Trial on Efficacy and Safety of FXIII Replenishment with two different Doses of Recombinant Factor XIII following Cardiopulmonary Bypass Surgery
    A.4.1Sponsor's protocol code numberNN1810-3540
    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 SponsorNovo Nordisk A/S
    B.1.3.4CountryDenmark
    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 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 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 nameFactor XIII recombinante (rFXIII)
    D.3.2Product code NN1810
    D.3.4Pharmaceutical form Powder for solution for injection
    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 INNCatridecacog
    D.3.9.1CAS number 606138-08-3
    D.3.9.3Other descriptive nameFactor XIII recombinante (rFXIII)
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 placeboPowder for solution for injection
    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
    Carencia adquirida de FXIII tras cirugía de derivación cardiopulmonar (IDAC (injerto de derivación arterial coronaria) o IDAC más un procedimiento de sustitución/reparación de una sola válvula cardiaca o una sustitución/reparación prevista de una sola válvula cardiaca .

    Aquired FXIII deficiency following cardiopulmonary bypass surgery (CABG (coronary atery bypass grafting) or CABG plus single heart valve replacement/repairs or planned replacement/repair of a single heart valve)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10063919
    E.1.2Term Bypass surgery
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Investigar si el tratamiento postoperatorio con una de dos dosis (17,5 ó 35 UI/kg de MCM) de FXIII recombinante (rFXIII) es eficaz para evitar las alotransfusiones en pacientes sometidos a cirugía de derivación cardiopulmonar (DCP) con una puntuación de riesgo de transfusión preoperatorio de 2 ó 3.
    E.2.2Secondary objectives of the trial
    Documentar el perfil de seguridad de rFXIII utilizado como tratamiento de reposición en la cirugía de derivación cardiopulmonar (DCP).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Obtención del consentimiento informado (CI) antes de cualquier actividad relacionada con el estudio. (Las actividades relacionadas con el estudio son cualquier procedimiento que no se habría realizado durante el tratamiento normal del sujeto).
    2. Edad: > ó = 18 - < ó = 80 años
    3. Pacientes que se vayan a someter a cirugía cardiaca (CC) con necesidad de DCP
    4. Previsto:
    - IDAC o
    - IDAC más sustitución/reparación de una sola válvula cardiaca o
    - sustitución/reparación prevista de una sola válvula cardiaca
    5. Puntuación del riesgo de transfusión preoperatorio de 2 ó 3 (Tabla 3 - 1 del protocolo)
    6. Uso perioperatorio de un antifibrinolítico
    E.4Principal exclusion criteria
    1. Alergia presunta o conocida a los fármacos del ensayo o productos relacionados
    2. Intolerancia conocida a la protamina
    3. Alergia presunta o conocida al antifibrinolítico utilizado
    4. Aleatorización y tratamiento previos en este ensayo
    5. Recepción de un fármaco en fase de investigación en los 30 días previos a la intervención quirúrgica
    6. Negativa a recibir sangre o hemoderivados
    7. Realización prevista de revascularización coronaria sin circulación extracorpórea (OPCAB)
    8. Uso perioperatorio previsto de desmopresina (DDAVP)
    9. Trombocitopenia inducida por heparina (TIH) conocida
    10. Carencia conocida de proteína C, proteína S, antitrombina o factor V Leiden homocigótico
    11. Trastornos hemorrágicos congénitos conocidos
    12. Intervención quirúrgica prevista que incluya el cayado aórtico o la aorta descendente
    13. Intervención quirúrgica prevista que incluya un dispositivo implantable de asistencia ventricular
    14. Cardiopatías congénitas en la edad adulta
    15. Presencia de endocarditis
    16. Previsión de parada circulatoria hipotérmica profunda (< 28º C)
    17. Dos o más procedimientos quirúrgicos cardiacos previos
    18. Procedimientos urgentes de cirugía cardiaca, es decir, aquellos que sean médicamente necesarios en las 24 horas siguientes a la presentación de síntomas agudos
    19. Derivación cardiopulmonar programada con preparación con eritrocitos.
    20. Cualquier enfermedad autoinmunitaria conocida:
    - Conjuntivopatías vasculares (lupus eritematoso sistémico, artritis reumatoide, síndrome de Sjögren)
    - Endocrina: hipertiroidismo (enfermedad de Grave), insuficiencia suprarrenal, tiroiditis de Hashimoto
    - Neurológica: esclerosis múltiple, miastenia grave
    - Cutánea: pénfigo vulgar
    - Hematológica: anemia perniciosa, anemia hemolítica autoinmunitaria
    - Vasculitis
    - Síndrome antifosfolípidos primario o secundario
    21. Antecedentes de ictus o de trastornos trombóticos no coronarios, como trombosis venosa profunda (TVP) y embolia pulmonar (EP)
    22. Insuficiencia cardiaca de clase > ó = III de la New York Heart Association (NYHA)
    23. Mujeres en edad fértil que estén embarazadas o en período de lactancia o que pretendan quedarse embarazadas o no utilicen métodos anticonceptivos adecuados (medidas anticonceptivas adecuadas tal como exijan la legislación y la práctica locales)
    24. Infarto agudo de miocardio (IAM) confirmado en los 7 días anteriores
    25. Recuento de plaquetas preoperatorio < 100.000 x 10^9/l
    26. SC < 1,9 m^2 y anemia: (hematócrito (Hct.) < 36 % (f) / Hct. < 39 % (m))
    27. Administración de clopidogrel o de otros antagonistas del receptor del fosfato de adenosina (ADP) en los tres días previos a la intervención quirúrgica
    28. Administración de bloqueantes del receptor de GPIIb/IIIa (abciximab, tirofibán, eptifibatida) < ó = 24 horas antes de la intervención quirúrgica
    29. Índice internacional (INR) > 1,5 el día de la intervención quirúrgica
    30. Disfunción hepática (aumento de la aspartato aminotransferasa (AST) o de la alanina aminotransferasa (ALT) > ó = 2 veces por encima del límite superior del intervalo normal del laboratorio)
    31. Insuficiencia renal (creatinina > ó = 175 µmol/l o diálisis)
    32. Fracción de eyección ventricular izquierda más reciente < 30 %
    33. Enfermedad tromboembólica actual distinta del infarto de miocardio
    34. Uso perioperatorio previsto de selladores de fibrina
    35. Uso de cualquier fármaco en fase de investigación
    36. Peso > ó = 140 kg
    E.5 End points
    E.5.1Primary end point(s)
    Porcentaje de pacientes que eviten cualquier alotransfusión (eritrocitos, plasma congelado en fresco (PCF), plaquetas, crioprecipitado, concentrado de fibrinógeno, concentrado de factores de la coagulación) durante siete días después de la intervención o hasta el alta, lo que ocurra primero.
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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 years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    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.1.3Elderly (>=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 state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 287
    F.4.2.2In the whole clinical trial 430
    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 Decision2009-05-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-05-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-02-23
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