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    Summary
    EudraCT Number:2010-023070-40
    Sponsor's Protocol Code Number:NN7999-3773
    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:2012-11-29
    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 number2010-023070-40
    A.3Full title of the trial
    An Open-label, Multi-centre, Un-controlled Trial to Assess Efficacy and Safety of NNC-0156-0000-0009 during Surgical Procedures in Patients with Haemophilia B
    Ensayo abierto, multicéntrico, no controlado para evaluar la eficacia y la seguridad de NNC 0156 0000 0009 durante las intervenciones quirúrgicas en pacientes con hemofilia B
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Open-label, Multi-centre, Un-controlled Trial to Assess Efficacy and Safety of NNC-0156-0000-0009 during Surgical Procedures in Patients with Haemophilia B
    Ensayo abierto, multicéntrico, no controlado para evaluar la eficacia y la seguridad de NNC 0156 0000 0009 durante las intervenciones quirúrgicas en pacientes con hemofilia B
    A.3.2Name or abbreviated title of the trial where available
    paradigm?3
    A.4.1Sponsor's protocol code numberNN7999-3773
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/292/2010
    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 supportNovo Nordisk A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovo Nordisk A/S
    B.5.2Functional name of contact pointGlobal Clinical Registry (GCR,1452)
    B.5.3 Address:
    B.5.3.1Street AddressVandtaarnsvej 114, VTB
    B.5.3.2Town/ citySoeborg
    B.5.3.3Post codeDK-2860
    B.5.3.4CountryDenmark
    B.5.6E-mailclinicaltrials@novonordisk.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/09/640
    D.3 Description of the IMP
    D.3.1Product nameN9-GP
    D.3.2Product code NNC 0156-0000-009
    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 INNN/A
    D.3.9.1CAS number 117551271-6
    D.3.9.2Current sponsor codeNNC 0156-0000-009
    D.3.9.3Other descriptive nameN/A
    D.3.10 Strength
    D.3.10.1Concentration unit U/ml unit(s)/millilitre
    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
    Haemophilia B
    Hemofilia B
    E.1.1.1Medical condition in easily understood language
    Bleeding disorder, inherited deficiency in clotting factor IX
    Desorden de la sangre, deficiencia del factor de coagulación IX
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10018939
    E.1.2Term Haemophilia B (Factor IX)
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the haemostatic effect of NNC-0156-0000-0009 during surgery procedures in patients with haemophilia B
    ?Evaluar el efecto hemostático de NNC 0156 0000 0009 durante procedimientos quirúrgicos en pacientes con hemofilia B
    E.2.2Secondary objectives of the trial
    ? To evaluate the haemostatic effect of NNC-0156-0000-0009 during surgery and the postoperative period
    ? To evaluate the general safety, including immunogenicity of N9-GP, when used for prevention and treatment of bleeding during surgery and the post-operative period
    ?Evaluar el efecto hemostático de NNC 0156 0000 0009 durante las intervenciones quirúrgicas y el período postoperatorio
    ?Evaluar la seguridad general, incluida la inmunogenicidad, de N9 GP cuando se utiliza para la prevención y el tratamiento de las hemorragias durante las intervenciones quirúrgicas y el período postoperatorio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? Patients with haemophilia B, aged 13-70 years and with a FIX activity of ?2%.
    ? Male patients with moderately severe or severe congenital haemophilia B with a FIX activity ?2% according to medical records
    ? History of at least 150 exposure days to other FIX products
    ? Scheduled major surgery
    ?Pacientes con hemofilia B, de 13 70 años y con una actividad del FIX ? 2% (solo para los nuevos pacientes: ?18 años).
    ?Varones con hemofilia B congénita moderada o grave y actividad del FIX ? 2% según la historia clínica
    ?Antecedentes de al menos 150 días de exposición a otros productos que contengan FIX.
    ?Cirugía mayor programada
    E.4Principal exclusion criteria
    ? Known history of FIX inhibitors based on existing medical records, laboratory report reviews and patient and LAR interviews
    ? Current FIX inhibitors ?0.6 BU (central laboratory)
    ? Previous arterial thrombotic events (e.g. myocardial infarction and intracranial thrombosis) or previous deep venous thrombosis or pulmonary embolism (as defined by available medical records)
    ? ALT >3 times the upper limit of normal reference ranges at screening (central laboratory)
    ? Immune modulating or chemotherapeutic medication
    ?Antecedentes conocidos de inhibidores frente a FIX basándose en las historias clínicas existentes, las revisiones de los informes de laboratorio y las entrevistas con los pacientes y los representantes legales.
    ?Inhibidores del FIX actuales ? 0,6 UB (laboratorio central)
    ?Acontecimientos trombóticos arteriales previos (p. ej., infarto de miocardio y trombosis intracraneal) o previa trombosis venosa profunda o embolia pulmonar (según las historias clínicas disponibles).
    ?ALT > 3 veces el límite superior del intervalo de referencia normal (laboratorio central)
    ?Tratamiento con inmunomoduladores o quimioterápicos.
    E.5 End points
    E.5.1Primary end point(s)
    Haemostatic effect during surgery evaluated by the four-point response scale, assessed by the Investigator/Surgeon
    ? Four-point response scale: Excellent, good, moderate, poor
    ?Efecto hemostático durante las intervenciones quirúrgicas medido por una escala de respuesta de cuatro puntos, evaluada por el investigador/cirujano el día de la intervención
    -Escala de respuesta de cuatro puntos: excelente, buena, moderada, escasa
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the day of surgery
    El día de la operación quirúrgica
    E.5.2Secondary end point(s)
    ? Consumption of N9-GP (U/kg BW) during surgery and post-operative period
    ? Transfusion requirements (fulfilling transfusion criteria) during surgery and the post-operative
    period
    ? Haemoglobin pre and post surgery start (0, 1h, 24 h and every 24 hours in the post-operative
    period)
    ? AE and SAEs reported during the trial period until the last visit
    ? Incidence of inhibitors against FIX (?0.6 BU) until the last visit
    ?Consumo de N9 GP (U/kg de peso corporal) durante la intervención y el período postoperatorio
    ?Necesidad de transfusiones (que cumplan los criterios de transfusión) durante la intervención quirúrgica y el período postoperatorio
    ?Hemoglobina antes y después del inicio de la intervención (0, 1 hora, 24 horas y cada 24 horas en el período postoperatorio)
    ?AA y AAG notificados durante el período del estudio hasta la última visita
    ?Incidencia de inhibidores frente al FIX (UB ? 0,6) hasta la última visita
    E.5.2.1Timepoint(s) of evaluation of this end point
    ? During surgery is defined as the time from knife to skin until last stitch.
    ? The post-operative period is defined as the time from Day 1 to Day 13 (this period can be
    extended with one additional week if judged be the Investigator). The patient can be discharged
    earliest at the Day 3, and can have the EOT visit earliest at Day 6.
    ? The last visit is defined as the EOT visit if the patient continues in the extension trial and as the
    follow-up visit if the patient does not continue in the extension trial. The EOT visit cannot be
    performed sooner than Day 6 and latest Day 13 (this period can be extended with one additional
    week if judged by the Investigator). The follow-up visit should take place 4 weeks ± 2 weeks
    after the EOT visit.
    ?Durante la intervención quirúrgica se define como el tiempo transcurrido entre la incisión inicial y la aplicación del último punto.
    ?El período postoperatorio se define como el tiempo transcurrido entre los días 1 y 13 (podrá prolongarse una semana más a criterio del investigador). Se realizarán evaluaciones diarias mientras el paciente permanezca hospitalizado y al menos hasta el día 3
    ?La última visita se define como la visita de FDE si el paciente continúa en el ensayo de extensión y como la visita de seguimiento si el paciente no continúa . La visita de FDE podrá realizarse no antes del día 6 y como muy tarde el día 13 (este período se podrá ampliar una semana más a criterio del investigador). La visita de seguimiento tendrá lugar 4 semanas ± 2 semanas después de la visita de FDE
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    European Union
    Canada
    Japan
    Malaysia
    Russian Federation
    South Africa
    Taiwan
    Thailand
    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
    LPLV
    UVUP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days15
    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: 2
    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: 2
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 6
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 state1
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 7
    F.4.2.2In the whole clinical trial 16
    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)
    N/A
    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 Decision2013-02-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-10
    P. End of Trial
    P.End of Trial StatusCompleted
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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
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