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    The EU Clinical Trials Register currently displays   43855   clinical trials with a EudraCT protocol, of which   7284   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:2010-022726-33
    Sponsor's Protocol Code Number:251001
    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:2011-11-03
    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 number2010-022726-33
    A.3Full title of the trial
    BAX 326 (factor IX recombinante): Estudio de continuación sobre la evaluación de seguridad, inmunogenicidad y eficacia hemostática en pacientes tratados previamente portadores de hemofilia B grave (nivel de FIX < 1 %) o moderadamente grave (nivel de FIX menor o igual a 2 %). BAX 326 (recombinant Factor IX): Evaluation of Safety, Immunogenicity, and
    Hemostatic Efficacy in Previously Treated Patients with Severe (FIX level < 1%)
    or Moderately Severe (FIX level 2%) Hemophilia B
    A Continuation Study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    BAX 326 (recombinant coagulation factor nine): Continuation of a study
    of the safety and effectiveness of the product in previously treated
    patients with severe or moderately severe hemophilia B.
    BAX326 (factor nueve de coagulación recombinante): continuación de un estudio de seguridad y eficacia del producto en pacientes con hemofilia b grave o moderadamente grave previamente tratados.
    A.3.2Name or abbreviated title of the trial where available
    BAX 326 Continuation
    A.4.1Sponsor's protocol code number251001
    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 SponsorBaxter 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 supportBaxterInnovations GmbH
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBaxter Innovations GmbH
    B.5.2Functional name of contact pointGuido Wuerth
    B.5.3 Address:
    B.5.3.1Street AddressWagramer Strasse 17 - 19
    B.5.3.2Town/ cityViena
    B.5.3.3Post code1220
    B.5.3.4CountryAustria
    B.5.4Telephone number43(1)20100 3489
    B.5.5Fax number43(1)20100 717
    B.5.6E-mailguido_wuerth@baxter.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 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 nameNA
    D.3.2Product code BAX326
    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 INNNonacog alfa
    D.3.9.1CAS number 181054-95-5
    D.3.9.2Current sponsor codeBAX 326
    D.3.9.3Other descriptive nameFactor IX de coagulación recombinante
    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 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 Yes
    D.3.11.13.1Other medicinal product typefactor IX humano de coagulación recombinante (rDNA) sintetizado por una línea celular de ovario de hámster chino (CHO) diseñada con ingeniería genética
    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 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 nameNA
    D.3.2Product code BAX326
    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 INNNonacog alfa
    D.3.9.1CAS number 181054-95-5
    D.3.9.2Current sponsor codeBAX326
    D.3.9.3Other descriptive nameFactor IX de coagulación recombinante
    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 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 Yes
    D.3.11.13.1Other medicinal product typefactor IX humano recombinante (rDNA) sintetizado por una línea celular de ovario de hámster chino (CHO) diseñada con ingeniería genética
    D.IMP: 3
    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 nameNA
    D.3.2Product code BAX326
    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 INNNonacog alfa
    D.3.9.1CAS number 181054-95-5
    D.3.9.2Current sponsor codeBAX326
    D.3.9.3Other descriptive nameFactor IX de coagulación recombinante
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2000
    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 Yes
    D.3.11.13.1Other medicinal product typefactor IX humano recombinante (rDNA) sintetizado por una línea celular de ovario de hámster chino (CHO) diseñada con ingeniería genética
    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
    Previously treated patients (PTPs) with severe (FIX level < 1%) or moderately severe (FIX
    level 2%) hemophilia B
    Pacientes con hemofilia B grave (nivel de FIX menor a 1%) o moderadamente grave (nivel de FIX menor o igual al 2%) tratados previamente.
    E.1.1.1Medical condition in easily understood language
    Previously treated patients with severe or moderately severe hemophilia
    B.
    Pacientes con hemofilia B grave o moderadamente grave tratados previamente.
    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 14.0
    E.1.2Level LLT
    E.1.2Classification code 10018939
    E.1.2Term Haemophilia B (Factor IX)
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To further evaluate safety, immunogenicity, and hemostatic efficacy of BAX 326 in those
    subjects who completed pivotal study 250901, until BAX 326 is licensed in the subjects
    country or until the total accumulation of at least 100 exposure days (EDs) of treatment with
    BAX 326, whichever occurs last
    To monitor incremental recovery of BAX 326 over time
    To evaluate changes in health-related quality of life (HR QoL) and health resource use
    - Evaluar mejor la seguridad, la inmunogenicidad y la eficacia hemostática de BAX 326 en los pacientes sometidos al estudio pivotal 250901 hasta que se autorice BAX 326 en el país de cada paciente o hasta completarse al menos 100 días de exposición (DE) a BAX 326, lo que ocurra más tarde.
    - Controlar la recuperación creciente de BAX 326 en el tiempo
    - Evaluar los cambios en la calidad de vida relacionada con la salud (CVRS) y la utilización de recursos sanitarios.
    E.2.2Secondary objectives of the trial
    n.a.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? The subject and/or legal representative has/have voluntartily
    provided signed informed consent.
    ? Subject has completed Baxter clinical study 250901.
    ? Subject was 12 to 65 years old at the time of screening for 250901
    study.
    ? Subject has severe (FIX level < 1%) or moderately severe (FIX level
    ? 2%) hemophilia B (based on the one stage activated partial
    thromboplastin time (aPTT) assay), as tested at screening at the central
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    laboratory.
    ? Subject has not developed an inhibitory FIX antibody during Baxter
    clinical study 250901.
    ? Subject is human immunodeficiency (HIV) negative or is HIV+ with a
    viral load < 200 particles/?L ~ <400,000 copies/mL
    ? Subject is immunocompetent as evidenced by a CD4 count ? 200
    cells/mm3.
    ? If female of childbearing potential, subject presents with a negative
    pregnancy test and agrees to continue employing adequate birth control
    measures for the duration of the study.
    ? Subject is willing and able to comply with the requirements of the
    protocol.
    El paciente o el representante legal han firmado el consentimiento informado.
    El paciente ha completado el protocolo 250901 del estudio clínico Baxter.
    El paciente tenía entre 12 y 65 años en el momento de la selección para el estudio 250901.
    Paciente con hemofilia B grave (nivel de FIX < 1 %) o moderadamente grave (nivel de FIX 2 %), de acuerdo con el ensayo de tiempo de tromboplastina parcial activado (TTPa) de una etapa, como desveló el examen de la selección en el laboratorio central.
    El paciente no ha desarrollado anticuerpos ni inhibidores de FIX durante el protocolo 250901 de estudio clínico Baxter.
    Paciente negativo al virus de inmunodeficiencia humana (VIH) o VIH+ con una carga viral < 200 partíulas/ìL, aproximadamente <400.000 copias/mL.
    Paciente inmunocompetente según evidencia un cifra de CD4 200 células/mm3.
    Si es mujer en edad fértil, la paciente presenta un test de embarazo negativo y acepta utilizar medidas anticonceptivas adecuadas durante el transcurso del estudio.
    Paciente dispuesto a cumplir los requisitos del protocolo y capaz de hacerlo.
    E.4Principal exclusion criteria
    ? The subject received factor IX product(s) other than BAX 326 upon
    completion of Baxter pivotal study 250901.
    ? The subject has been diagnosed with an acquired hemostatic defect
    other than hemophilia B.
    ? The subject's weight is < 35 kg or > 120 kg.
    ? The subject's platelet count is < 100,000/mL.
    ? The subject has an abnormal renal function (serum creatinine > 1.5
    times the upper limit of normal).
    ? The subject has active hepatic disease with alanine aminotransferase
    (ALT) or aspartate aminotransferase (AST) levels ? 5 times the upper
    limit of normal.
    ? The subject is scheduled to receive during the course of the study, an
    immunomodulating drug (e.g. corticosteroid agents at a dose equivalent
    to hydrocortisone greater than 10 mg/day, or ?-interferon) other than
    anti-retroviral chemotherapy.
    ? The subject has a clinically significant medical, psychiatric, or
    cognitive illness, or recreational drug/alcohol use that, in the opinion of
    the investigator, would affect subject's safety or compliance.
    ? The subject is planned to take part in any other clinical study, with the
    exception of BAX 326 Surgery study as described in this protocol, during
    the course of the Continuation Study.
    ? The subject is a member of the team conducting this study or is in a
    dependent relationship with one of the study team members. Dependent
    relationships include close relatives (i.e., children, partner/spouse,
    siblings, parents) as well as employees of the investigator or site
    personnel conducting the study.
    El paciente recibió productos de factor IX distintos a BAX 326 hasta haberse completado el protocolo 250901 del estudio pivotal Baxter.
    Paciente con diagnóstico de un defecto hemostático adquirido distinto a la hemofilia B.
    Paciente con un peso inferior a 35 kg o superior a 120 kg.
    Cifra de plaquetas del paciente < 100.000/mL.
    Paciente con alteraciones en la función renal (creatinina en suero > 1,5 veces el límite superior del intervalo normal).
    Paciente con enfermedad hepática activa con niveles de alanina aminotransferasa (ALT) o aspartato aminotransferasa (AST) 5 veces el límite superior del intervalo normal.
    Paciente que tiene programada la administración durante el transcurso del estudio de una medicación inmunomoduladora (p. ej. agentes corticoesteroides a una dosis equivalente a más de 10 mg/día de hidrocortisona o interferón á) distinta a la quimioterapia antirretroviral.
    Paciente con una patología médica, psiquiátrica o cognitiva significativa, o consumo de drogas y alcohol que según el investigador podría afectar a la seguridad o conformidad del paciente.
    El paciente tiene prevista la participación en otro estudio clínico, salvo en el estudio quirúrgico BAX 326 como se describe en el presente protocolo, durante el transcurso del estudio de continuación.
    El paciente forma parte del equipo que realiza este estudio o se encuentra en relación de dependencia con uno de los miembros del equipo del estudio. Las relaciones de dependencia incluyen a los parientes cercanos (es decir, hijos, pareja o cónyuge, hermanos, padres), así como a lo empleados del investigador o al personal del centro encargado del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Adverse events possibly or probably related to IP
    Acontecimientos adversos probablemente relacionados con el PI
    E.5.1.1Timepoint(s) of evaluation of this end point
    end of the trial
    final del estudio
    E.5.2Secondary end point(s)
    Safety and immunogenicity
    Pharmacokinetics
    Hemostatic efficacy
    Health related Quality of Life and Health Resource Use
    Seguridad e inmunogenicidad
    Farmcocinéticas
    Eficacia hemostática
    Cuestionarios relativos a la Calidad de Vida y el uso de recursos sanitarios (farmacoeconomía)
    E.5.2.1Timepoint(s) of evaluation of this end point
    end of the trial
    final del estudio
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    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 Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity, hemostatic efficacy
    Immunogenicidad, Eficacia hemostatica
    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 No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    Argentina
    Brazil
    Chile
    Colombia
    Japan
    Russian Federation
    Ukraine
    United States
    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
    Not applicable (licensure of BAX326 in subject's respective country).
    No aplicable (de acuerdo a la licencia de BAX326 en cada uno de los países respectivos de los sujetos)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    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 Yes
    F.1.1Number of subjects for this age range: 1
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 1
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Minors 12-17 years
    Menores 12-17 años
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 60
    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)
    The patients included in the continuation study 251001 will be treated
    with BAX 326 until the commercial product is available, therefore the
    continuous treatment of patients is warranted.
    Los pacientes incluidos en el estudio de continuación 251001 serán tratados con BAX 326 hasta que el producto autorizado se encuentre disponigle, de esta manera se garantiza el tratamiento continuado de los pacientes.
    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 Decision2011-05-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-04-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-06-29
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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