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    Summary
    EudraCT Number:2021-000740-21
    Sponsor's Protocol Code Number:LEX-210
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-07-01
    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 number2021-000740-21
    A.3Full title of the trial
    Study of four-factor prothrombin complex concentrate, OCTAPLEX, in patients with acute major bleeding on direct oral anticoagulant (DOAC) therapy with factor Xa inhibitor.
    Estudio del concentrado de complejo de protombina de cuatro factores OCTAPLEX en pacientes con hemorragia grave aguda en tratamiento con anticoagulantes orales directos (ACOD) con inhibidor del factor Xa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to demonstrate the efficacy and safety of OCTAPLEX in patients with acute major bleeding that are taking direct oral anticoagulant.
    Estudio para demostrar la eficacia y la seguridad de OCTAPLEX en pacientes con hemorragias graves agudas que toman anticoagulantes orales directos.
    A.4.1Sponsor's protocol code numberLEX-210
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04867837
    A.5.4Other Identifiers
    Name:INDNumber:18149
    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 SponsorOctapharma AG
    B.1.3.4CountrySwitzerland
    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 supportOctapharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOctapharma AG
    B.5.2Functional name of contact pointClinical Project Manager
    B.5.3 Address:
    B.5.3.1Street AddressSeidenstrasse 2
    B.5.3.2Town/ cityLachen
    B.5.3.3Post code8853
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41554512177
    B.5.6E-mailcorlex-210@octapharma.com
    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 Octaplex
    D.2.1.1.2Name of the Marketing Authorisation holderOctapharma Pharmazeutika Produktionsges.m.b.H
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameOctaplex
    D.3.4Pharmaceutical form Powder and solvent for concentrate for solution for infusion
    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 INNOctaplex
    D.3.9.1CAS number 37224-63-8
    D.3.9.3Other descriptive namePROTHROMBIN COMPLEX CONCENTRATES
    D.3.9.4EV Substance CodeSUB33011
    D.3.10 Strength
    D.3.10.1Concentration unit IU international 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 Yes
    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 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 Octaplex
    D.2.1.1.2Name of the Marketing Authorisation holderOctapharma Pharmazeutika Produktionsges.m.b.H
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameOctaplex
    D.3.4Pharmaceutical form Powder and solvent for concentrate for solution for infusion
    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 INNOctaplex
    D.3.9.1CAS number 37224-63-8
    D.3.9.3Other descriptive namePROTHROMBIN COMPLEX CONCENTRATES
    D.3.9.4EV Substance CodeSUB33011
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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 Yes
    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
    Acute major bleeding in patients receiving DOAC therapy with factor Xa inhibitor
    Hemorragia grave aguda en pacientes que reciben tratamiento con DOAC e inhibidores del factor Xa
    E.1.1.1Medical condition in easily understood language
    Acute major bleeding in patients on oral anticoagulants
    Hemorragia grave aguda en pacientes con anticoagulantes orales
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10009731
    E.1.2Term Coagulation disorder
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate superior haemostatic effectiveness of OCTAPLEX dosed at 50 IU/Kg body weight vs. 15 IU/Kg body weight for emergency reversal of the anticoagulant effect of DOACs in patients with major bleeding associated with factor Xa inhibition.
    Demostrar la superioridad de la eficacia hemostática de OCTAPLEX administrado a 50 UI/kg de peso corporal frente a 15 UI/kg de peso corporal para la reversión de urgencia del efecto anticoagulante de los ACOD en pacientes con hemorragia grave asociada a la inhibición del factor Xa.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of OCTAPLEX on thrombin generation in patients with acute major bleeding on DOAC therapy with factor Xa inhibitor.

    To evaluate the safety of OCTAPLEX in patients with acute major bleeding on DOAC therapy with factor Xa inhibitor.
    Evaluar el efecto de OCTAPLEX en la generación de trombina en pacientes con hemorragia grave aguda en tratamiento con ACOD con inhibidor del factor de Xa.

    Evaluar la seguridad de OCTAPLEX en pacientes con hemorragia grave aguda en tratamiento con ACOD con inhibidor del factor de Xa.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients who received or who are believed by the investigator to have received a dose of oral factor Xa inhibitor
    • Aged ≥18 years
    • Patients who have given written informed consent or for whom written informed consent has been obtained from the patient's legally authorised representative on their behalf
    • Patients who have acute major bleeding defined as follows:
    - Bleeding that is potentially life-threatening or uncontrolled, e.g., with signs or symptoms of haemodynamic compromise, such as severe hypotension, poor skin perfusion, or low cardiac output that cannot be otherwise explained
    OR
    - Symptomatic bleeding in critical organs (intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, pericardial, or intramuscular with compartment syndrome)
    OR
    - Acute overt bleeding associated with a fall in haemoglobin (Hgb) level of ≥2 g/dL, OR a Hgb level ≤8 g/dL if no baseline Hgb level is available, OR in the opinion of the investigator that the patient’s Hgb level will fall to ≤8 g/dL with resuscitation
    • Patients with baseline anti-factor Xa activity equivalent to at least 100 ng/mL according to the available test (e.g., chromogenic assay)
    Pacientes que hayan recibido o que el investigador crea que han recibido una dosis de inhibidor del factor Xa oral
    • Edad ≥18 años
    • Pacientes que hayan dado su consentimiento informado por escrito o para los que se haya obtenido el consentimiento informado por escrito del representante legalmente autorizado del paciente en su nombre.
    • Pacientes con hemorragia grave aguda, definida como sigue:
    - Hemorragia potencialmente mortal o sin controlar, p. ej., con signos y síntomas de afectación hemodinámica, como hipotensión grave, perfusión cutánea deficiente o gasto cardiaco bajo que no pueda explicarse de otro modo
    O
    - Hemorragia sintomática en órganos esenciales (intracraneal, intravertebral, intraocular, retroperitoneal, intraarticular, pericárdica o intramuscular con síndrome compartimental)
    O
    - Hemorragia aguda manifiesta asociada a una disminución del nivel de hemoglobina (Hgb) de ≥2 g/dl O un nivel de Hgb ≤8 g/dl si no se dispone del nivel de Hgb inicial O, a juicio del investigador, que el nivel de Hgb del paciente vaya a disminuir a ≤8 g/dl con la reanimación
    • Pacientes con actividad antifactor Xa inicial equivalente a al menos 100 ng/ml de acuerdo con la prueba disponible (p. ej., ensayo cromogénico)
    E.4Principal exclusion criteria
    • Patients with bleeding that is immediately life-threatening
    • Patients with ‘Do not resuscitate’ (DNR) orders
    • Patients with acute trauma for which reversal of DOAC therapy with factor Xa inhibitor alone would not be expected to control the bleeding event
    • Hgb decrease without accompanying evidence of source of bleeding
    • Acute coronary syndrome, ischaemic stroke or venous thromboembolism (VTE) within the preceding 3 months
    • Patients with a history, within the last 3 months, of disseminated intravascular coagulation (DIC) or hyperfibrinolysis
    • Patients with a known congenital bleeding disorder
    • Known inhibitors to coagulation factors II, VII, IX, or X; heparin-induced, type II thrombocytopenia; or immunoglobulin A (IgA) deficiency with known antibodies against IgA
    • Known hypersensitivity to plasma-derived products
    • Patients who received haemostatic agents, including plasma, platelets, PCC, activated PCC (aPCC), recombinant factor VIIa, or recombinant factor Xa inactivated-zhzo (andexanet alfa), for the current bleeding event prior to enrolment (antifibrinolytic drugs and local haemostatic agents are allowed)
    • Patients who received ticlopidine within 14 days, prasugrel within 7 days, clopidogrel within 5 days, ticagrelor within 5 days or cangrelor within 1 hour preceding the bleeding event
    • Patients on enoxaparin therapy for thromboembolic prophylaxis
    • A score of less than 7 on the Glasgow Coma Scale or an estimated intracerebral haematoma volume of more than 60 mL
    • Patients with expected survival of less than 3 days
    • Patients scheduled to undergo surgery in less than 12 hours, with the exception of some minor/invasive procedures that are allowed for diagnostic or therapeutic reasons (see Section 4.1.2)
    • Patients who are pregnant or breastfeeding at the time of enrolment
    • Patients previously enrolled in this study
    • Patients participating in another interventional clinical treatment study currently or during the past 1 month prior to study inclusion
    Pacientes con hemorragia que sea potencialmente mortal de inmediato (véase el apartado 4.1.2)
    2. Pacientes con órdenes de no reanimación
    3. Pacientes con traumatismos agudos para los que no se espera que la reversión del tratamiento con ACOD con inhibidor del factor Xa por sí solo controle el acontecimiento hemorrágico
    4. Disminución de la Hgb sin evidencia de la fuente de la hemorragia
    5. Síndrome coronario agudo, accidente cerebrovascular isquémico o tromboembolia venosa (TEV) en los 3 meses anteriores
    6. Pacientes con antecedentes, en los últimos 3 meses, de coagulación intravascular diseminada (CID) o hiperfibrinólisis
    7. Pacientes con un trastorno hemorrágico congénito conocido
    8. Inhibidores conocidos de los factores de coagulación II, VII, IX o X; trombocitopenia de tipo II inducida por heparina; o deficiencia de inmunoglobina A (IgA) con anticuerpos conocidos frente a IgA
    9. Hipersensibilidad conocida a los productos derivados de plasma
    10. Pacientes que recibieron fármacos hemostáticos, incluido plasma, plaquetas, CCP, CCP activado (CCPa), factor VIIa recombinante o factor Xa recombinante con zhzo inactivado (andexanet alfa) para el acontecimiento hemorrágico actual con anterioridad a la inclusión (se permiten los fármacos antifibrinolíticos y los fármacos hemostáticos locales)
    11. Pacientes que recibieron ticlopidina en los 14 días anteriores, Prasugrel en los 7 días anteriores, clopidogrel en los 5 días anteriores, ticagrelor en los 5 días anteriores o cangrelor en la hora anterior al acontecimiento hemorrágico
    12. Pacientes en tratamiento con enoxaparina para la profilaxis tromboembólica
    13. Una puntuación de menos de 7 en la Escala de Coma de Glasgow o un volumen estimado del hematoma intracerebral de más de 60 ml
    14. Pacientes con una supervivencia prevista de menos de 3 días
    15. Pacientes que tienen programado someterse a cirugía en menos de 12 horas, a excepción de algunos procedimientos menos/invasivos que se permiten por razones diagnósticas o terapéuticas
    16. Pacientes que estén embarazadas o en periodo de lactancia en el momento de la inclusión
    17. Pacientes incluidos anteriormente en este estudio
    18. Pacientes que participen en otro estudio con un tratamiento clínico intervencionista en la actualidad
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of patients in whom OCTAPLEX demonstrates haemostatic effectiveness, i.e., binary outcome of effective (rating of excellent or good) or non-effective (rating of poor/none) in management of major bleeding events.
    La proporción de pacientes en los que OCTAPLEX demuestre una eficacia hemostática, es decir, variable binaria de eficaz (valoración de excelente o buena) o no eficaz (valoración de deficiente/ninguna) en el tratamiento de los acontecimientos hemorrágicos graves
    E.5.1.1Timepoint(s) of evaluation of this end point
    Within 24 hours after the start of initial management, as assessed by the Independent Data Monitoring and Endpoint Adjudication Committee (IDMEAC) according to predefined criteria (Section 7.2 of the protocol).
    En las 24 horas posteriores al inicio del tratamiento inicial, según la evaluación del Comité de Monitorización de Datos y Adjudicación de Criterios (IDMEAC, en inglés) de acuerdo con los criterios preestablecidos (Seccion 7.2 del protocolo)
    E.5.2Secondary end point(s)
    • Change in endogenous thrombin potential (ETP) as measured by thrombin generation assay (TGA) from baseline to 1 hour after OCTAPLEX administration
    • 30-day event rate of thromboembolic events (TEEs) and all-cause mortality
    • Occurrence of adverse events (AEs) during a 48-hours follow up period after OCTAPLEX administration
    • Vital signs and laboratory parameters during a 48-hours follow up period after OCTAPLEX administration
    Cambio en el potencial endógeno de trombina (ETP, en inglés), según la medición
    del ensayo de generación de trombina (TGA) desde el inicio hasta 1 hora después de la administración de OCTAPLEX Tasa de acontecimientos tromboembólicos (ATE) a los 30 días y mortalidad por cualquier causa Aparición de acontecimientos adversos (EA) durante un período de seguimiento de 48 horas tras la administración de OCTAPLEX Signos vitales y parámetros de laboratorio durante
    un período de seguimiento de 48 horas después de la administración de OCTAPLEX
    E.5.2.1Timepoint(s) of evaluation of this end point
    From baseline to 30 days after infusion.
    Desde el inicio hasta 30 días después de la infusión.
    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) 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Mismo fármaco con distinta dosis
    Same study drug with different dose
    E.8.2.4Number of treatment arms in the trial2
    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 EEA30
    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
    United States
    Austria
    France
    Poland
    Spain
    Germany
    Ukraine
    United Kingdom
    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
    Last visit last subject
    Última visita del último paciente.
    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 months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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: 80
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Potentially unconscious subjects.
    Sujetos potencialmente inconscientes
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 200
    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)
    Medical treatment according to local standards.
    Tratamiento médico según el estándar local.
    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 Decision2022-07-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-28
    P. End of Trial
    P.End of Trial StatusOngoing
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