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    Summary
    EudraCT Number:2015-005521-39
    Sponsor's Protocol Code Number:241502
    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:2016-04-20
    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 number2015-005521-39
    A.3Full title of the trial
    A Phase 3, Multicenter, Single-arm, Open-label Study of the Efficacy and Safety of B-Domain Deleted Recombinant Porcine Factor VIII (BAX 802) in Subjects with Congenital Hemophilia A with Factor VIII Inhibitors Undergoing Surgical or Other Invasive Procedures
    Estudio de fase III, multicéntrico, de un solo brazo y abierto sobre la eficacia y la seguridad del factor VIII recombinante porcino con dominio B suprimido (BAX 802) en sujetos con hemofilia A congénita con inhibidores del factor VIII sometidos a intervenciones quirúrgicas u otros procedimientos invasivos.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of the Efficacy and Safety of Drug BAX 802 in Subjects with Congenital Hemophilia A with Factor VIII Inhibitors Undergoing Surgical or Other Invasive Procedures
    Estudio sobre la eficacia y seguridad del fármaco BAX 802 en sujetos con hemofilia A congénita con inhibidores del factor VIII sometidos a intervenciones quirúrgicas u otros procedimientos invasivos.
    A.3.2Name or abbreviated title of the trial where available
    BAX802 in Congenital Hemophilia A with Inhibitors
    BAX802 en Hemofilia A Congénita con Inhibidores
    A.4.1Sponsor's protocol code number241502
    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 SponsorBaxalta Innovations GmbH
    B.1.3.4CountryAustria
    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 supportBaxalta Innovations GmbH
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBaxalta Innovation GmbH
    B.5.2Functional name of contact pointClinical Development
    B.5.3 Address:
    B.5.3.1Street AddressIndustriestrasse 67
    B.5.3.2Town/ cityVienna`
    B.5.3.3Post codeA-1221
    B.5.3.4CountryAustria
    B.5.4Telephone number+43120100 2472930
    B.5.5Fax number+43120100 2475733
    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 OBIZUR
    D.2.1.1.2Name of the Marketing Authorisation holderBaxalta Innovations GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameObizur
    D.3.2Product code BAX802
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    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 INNSusoctocog alfa
    D.3.9.2Current sponsor codeBAX802
    D.3.9.3Other descriptive nameSUSOCTOCOG ALFA
    D.3.9.4EV Substance CodeSUB166390
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 Yes
    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
    Congenital Haemophilia A with Factor VIII Inhibitors
    Hemofilia A congénitca con inhibidores del factor VIII
    E.1.1.1Medical condition in easily understood language
    Congenital Haemophilia A with Factor VIII Inhibitors
    Hemofilia A congénitca con inhibidores del factor VIII
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10053751
    E.1.2Term Hemophilia A with anti factor VIII
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to evaluate the perioperative hemostatic efficacy of BAX 802 in male subjects with CHA with inhibitors to hFVIII undergoing major or minor elective surgical, dental, or other invasive procedures as determined by the Global Hemostatic Efficacy Assessment (GHEA) score.
    El objetivo primario del estudio es evaluar la eficacia hemostática perioperatorio de BAX 802 en sujetos masculinos con CHA con inhibidores de hFVIII sometidos a procedimientos invasivos quirúrgicos, dentales, u otros electivos mayores o menores según lo determinado por la puntuación de Evaluación Global eficacia hemostática (GHEA) .
    E.2.2Secondary objectives of the trial
    To determine:
    1. the safety of BAX 802 in the perioperative setting by assessing the occurrence of thrombotic events and/or allergic reactions, AEs and clinically significant changes in vital signs/routine laboratory parameters related to BAX 802. Also by assessing the development of and change in titer of anti-pFVIII and anti-hFVIII inhibitory antibodies, and development of binding antibodies to BHK proteins.
    2. The intra- and postoperative and overall perioperative blood loss at the end of surgery, compared to the estimated volume of expected average and maximum blood loss in a comparable healthy individual as predicted preoperatively by the investigator/surgeon.
    3. The daily and total weight-adjusted administration of BAX 802 per subject.
    4. The blood product utilization.
    5. The occurrence of bleeding episodes during the intra- and postoperative periods and additional need for surgical intervention.
    6. To evaluate any unrelated bleeding episodes in the postoperative period.
    Para determinar:
    1.La seguridad de BAX 802 en el contexto perioperatorio mediante la evaluación de la ocurrencia de eventos trombóticos y/o reacciones alérgicas, adversas y cambios clínicamente significativos en los signos vitales/parámetros de laboratorio de rutina relacionados con BAX 802. También mediante la evaluación del desarrollo y variación de título de anticuerpos anti-pFVIII y los anticuerpos inhibidores anti-hFVIII, y el desarrollo de anticuerpos de unión a BHK proteínas.
    2.La pérdida de sangre perioperatoria intra y postoperatoria y en general final de la cirugía, en comparación con el volumen estimado de la pérdida de sangre media y máxima esperada en un individuo sano comparable predijo antes de la operación por el investigador/cirujano.
    3.La administración ajustada al peso diario y total de BAX 802 por sujeto . 4. La utilización de producto de la sangre.
    Más objetivos por favor ver protocolo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject is ? 18 to ? 65 years old at the time of screening
    2. Subject has provided signed informed consent
    3. Subject has severe (FVIII level < 1%) or moderately severe (FVIII level ? 2%) CHA with inhibitors to human FVIII, as tested at screening at the central laboratory
    4. Subject requires elective surgery or other invasive procedures
    5. Subject is not currently receiving or has received (< 30 days) ITI therapy
    6. Subject has a Karnofsky performance score of ? 60
    7. Subject is human immunodeficiency virus negative (HIV-); or HIV+ with stable disease and CD4+ count ? 200 cells/mm3 at screening
    8. Subject is hepatitis C virus negative (HCV-) by antibody or polymerase chain reaction (PCR) testing; or HCV+ with chronic stable hepatitis disease
    9. Subject is willing and able to comply with the requirements of the protocol.
    1. Sujetos ? 18 y ? 65 años de edad en el momento de la selección.
    2. Sujetos que han firmado el consentimiento informado.
    3. Sujetos con HAC grave (concentración de FVIII < 1 %) o moderadamente grave (concentración de FVIII ? 2 %) con inhibidores del FVIII humano, determinada en el momento de la selección en el laboratorio central.
    4. Sujetos que requieren cirugía programada u otro procedimiento invasivo.
    5. Sujetos que no están recibiendo o no han recibido recientemente (< 30 días) tratamiento de ITI.
    6. Sujetos con una puntuación del estado general de Karnofsky ? 60.
    7. Sujetos que son negativos para el virus de la inmunodeficiencia humana (VIH-); o son VIH+ con enfermedad estable y un recuento de CD4+ ? 200 células/mm3 en la selección.
    8. Sujetos que son negativos para el virus de la hepatitis C (VHC-) mediante determinación de anticuerpos o por reacción en cadena de la polimerasa (RCP), o son VHC+ con hepatitis crónica estable.
    9. Sujetos que están dispuestos y son capaces de cumplir con los requisitos del protocolo.
    E.4Principal exclusion criteria
    1. The subject requires emergency surgery
    2. The subject?s weight is < 35 kg or > 120 kg
    3. Clinically symptomatic liver disease (eg, ? 5 X upper limit of normal alanine aminotransferase [ALT], as confirmed by central laboratory at screening, clinical evidence of portal hypertension, severe hypoalbuminemia or a documented prothrombin time/international normalized ratio (PT/INR) > 1.5)
    4. Clinically symptomatic renal disease (serum creatinine > 2.0 mg/dL), as confirmed by central laboratory at screening
    5. Anti-porcine inhibitor > 10 BU prior to surgery
    6. Platelet count < 100,000/?L
    7. Subject has another active coagulation disorder other than haemophilia A, as per the medical history
    8. Planned use of ?-interferon with or without ribavarin for HCV infected patients or planned use of a protease inhibitor for HIV infected patients. Patients currently taking any of these medications for ? 30 days are eligible
    9. Known hypersensitivity to rpFVIII, or hamster or murine proteins
    10. Subject has been exposed to an IP within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study
    11. Unable to tolerate quantity of blood to be drawn for protocol procedures
    12. Subject is a family member or employee of the investigator.
    1. Sujetos que requieren cirugía de urgencia.
    2. Sujetos con un peso < 35 kg o > 120 kg.
    3. Hepatopatía clínicamente sintomática (p. ej., ? 5 veces el límite superior de la normalidad de la alanina aminotransferasa [ALT], confirmado por el laboratorio central en la selección, indicios clínicos de hipertensión portal, hipoalbuminemia grave o tiempo de protrombina/índice internacional normalizado [TP/INR] > 1,5 documentados).
    4. Nefropatía clínicamente sintomática (creatinina sérica > 2,0 mg/dl) confirmada por el laboratorio central en la selección.
    5. Inhibidor antiporcino > 10 unidades Bethesda (UB) antes de la cirugía.
    6. Recuento de plaquetas < 100 000/µl.
    7. Sujetos con otro trastorno de la coagulación activo, distinto a la hemofilia A, según los antecedentes médicos.
    8. Utilización programada de interferón ?, con o sin ribavarina, en pacientes infectados por el VHC o utilización programada de un inhibidor de la proteasa en pacientes infectados por el VIH. Los pacientes que están recibiendo actualmente alguno de estos medicamentos desde hace ? 30 días se consideran aptos.
    9. Hipersensibilidad conocida al FVIIIrp o a las proteínas murinas o de hámster.
    10. Sujetos que han estado expuestos a un PEI en los 30 días anteriores a la inscripción o está programado que participen en otro estudio clínico con un PEI o un dispositivo en investigación durante el transcurso de este estudio.
    11. Incapacidad para tolerar la extracción de sangre para los procedimientos del protocolo.
    12. Sujetos que son familiares o empleados del investigador.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure is the GHEA score which is composed of 3 individual ratings:
    Assessment of intraoperative hemostatic efficacy of BAX 802 performed by the operating surgeon
    Assessment of postoperative hemostatic efficacy of BAX 802 at postoperative Day 1 (approximately 24 hours after surgery) performed by the operating surgeon
    Assessment of overall perioperative hemostatic efficacy of BAX 802 at Day 14 or discharge (whichever is earlier), performed by the investigator

    The scores of each of the 3 individual ratings described above, will be added together to form a GHEA score.
    La medida de resultado primario es la puntuación GHEA que se compone de 3 clasificaciones individuales :
    Evaluación de la eficacia hemostática intraoperatoria de BAX 802 realizada por el cirujano.
    Evaluación de la eficacia hemostática postoperatorio de BAX 802 en el día 1 tras la operación (aproximadamente 24 horas después de la cirugía) realizado por el cirujano.
    Evaluación de la eficacia global hemostático perioperatorio de BAX 802 en el día 14 o descarga (lo que ocurra primero), realizado por el investigador.
    Las puntuaciones de cada una de las 3 notas individuales descritas anteriormente, se suman para formar una puntuación GHEA .
    E.5.1.1Timepoint(s) of evaluation of this end point
    Varying times as defined by the protocol.
    Tiempos variables definidos en el protocolo.
    E.5.2Secondary end point(s)
    Efficacy
    1. Blood loss compared to the estimated volume of expected average blood loss and expected maximum blood loss in a comparable healthy individual as predicted preoperatively by the investigator/surgeon at the following time points:
    ? Intraoperative, at the end of surgery
    ? Postoperative Day 1, approximately 24 hours after surgery
    ? Overall perioperative Day 14 or discharge (whichever is earlier)
    2. Daily and total weight-adjusted administration of BAX 802 per subject
    3. Volume of blood, red blood cells, platelets, and other blood products transfused
    4. Occurrence of bleeding episodes during the intra- and postoperative periods and additional need for surgical intervention
    5. Efficacy of the treatment of unrelated bleeding episodes in the postoperative period.

    Safety
    1. Development of, and changes to, the titer of inhibitory and binding antibodies to rpFVIII
    2. Development of, and changes to, the titer of inhibitory and binding antibodies to hFVIII
    3. Development of binding antibodies to BHK proteins
    4. Occurrence of thrombotic events
    5. Incidence of severe allergic reactions (eg, anaphylaxis)
    6. Incidence of other IP-related AEs
    7. Incidence of clinically significant changes in vital signs and routine laboratory parameters (hematology, clinical chemistry)
    Eficacia
    1. Pérdida de sangre en comparación con el volumen estimado de pérdida de sangre media esperada y con la pérdida de sangre máxima esperada en un individuo sano comparable, según previsión preoperatoria del investigador/cirujano en los siguientes puntos temporales:
    ? Intraoperatorio, al final de la intervención.
    ? Día 1 del posoperatorio, aproximadamente 24 horas después de la cirugía.
    ? Día 14 del periodo perioperatorio global o momento de recibir el alta (lo que primero suceda).
    2. Administración diaria y total ajustada al peso de BAX 802 por sujeto.
    3. Volumen de sangre, eritrocitos, plaquetas y otros hemoderivados transfundidos.
    4. Presencia de episodios hemorrágicos durante los periodos intra y posoperatorio y necesidad adicional de intervención quirúrgica.
    5. Eficacia del tratamiento de episodios hemorrágicos no relacionados en el periodo posoperatorio.
    Seguridad
    1. Aparición y cambios en los títulos de anticuerpos inhibidores y de fijación contra el factor VIII recombinante porcino (FVIIIrp).
    2. Aparición y cambios en los títulos de anticuerpos inhibidores y de fijación contra el FVIIIh.
    3. Aparición de anticuerpos de fijación frente a las proteínas BHK.
    4. Presencia de acontecimientos trombóticos.
    5. Incidencia de reacciones alérgicas graves (p. ej., anafilaxis).
    6. Incidencia de otros AA relacionados con el PEI.
    7. Incidencia de cambios clínicamente significativos en las constantes vitales y en los parámetros analíticos habituales (hematología y bioquímica clínica).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Varying times as defined by the protocol.
    Tiempos variables definidos en el protocolo.
    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 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 No
    E.8.1.1Randomised No
    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 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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    France
    Hungary
    Italy
    Netherlands
    Norway
    Poland
    Russian Federation
    Spain
    Sweden
    United Kingdom
    United States
    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
    Última visita del último sujeto
    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 months8
    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 months8
    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 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: 14
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female No
    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 No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 14
    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)
    Normal treatment to be continued as discussed with the subject's doctor.
    Se continuará con el tratamiento normal según criterio del médico del sujeto.
    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 Decision2016-06-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2021-01-11
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