- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01386528
Efficacy and Safety of NNC-0156-0000-0009 During Surgical Procedures in Subjects With Haemophilia B (paradigm™ 3)
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
This trial is conducted in Africa, Asia, Europe and the United States of America (USA).
The aim of the trial is to evaluate the safety and efficacy of NNC-0156-0000-0009 (nonacog beta pegol) during surgical procedures in patients with haemophilia B.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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Basingstoke, Det Forenede Kongerige, RG24 9NA
- Novo Nordisk Investigational Site
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Cardiff, Det Forenede Kongerige, CF14 4XW
- Novo Nordisk Investigational Site
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London, Det Forenede Kongerige, NW3 2QG
- Novo Nordisk Investigational Site
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London, Det Forenede Kongerige, SE1 7EH
- Novo Nordisk Investigational Site
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Manchester, Det Forenede Kongerige, M13 9WL
- Novo Nordisk Investigational Site
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Oxford, Det Forenede Kongerige, OX3 7LJ
- Novo Nordisk Investigational Site
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California
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Los Angeles, California, Forenede Stater, 90027
- Novo Nordisk Investigational Site
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San Francisco, California, Forenede Stater, 94143
- Novo Nordisk Investigational Site
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District of Columbia
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Washington, D.C., District of Columbia, Forenede Stater, 20007
- Novo Nordisk Investigational Site
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Georgia
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Augusta, Georgia, Forenede Stater, 30912
- Novo Nordisk Investigational Site
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Iowa
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Iowa City, Iowa, Forenede Stater, 52242
- Novo Nordisk Investigational Site
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New York
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Syracuse, New York, Forenede Stater, 13210
- Novo Nordisk Investigational Site
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Texas
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Houston, Texas, Forenede Stater, 77030
- Novo Nordisk Investigational Site
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Kremlin-Bicêtre, Frankrig, 94270
- Novo Nordisk Investigational Site
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Lyon, Frankrig, 69003
- Novo Nordisk Investigational Site
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Athens, Grækenland, GR-11527
- Novo Nordisk Investigational Site
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Utrecht, Holland, 3584 CX
- Novo Nordisk Investigational Site
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Firenze, Italien, 50134
- Novo Nordisk Investigational Site
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Milano, Italien, 20124
- Novo Nordisk Investigational Site
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Kashihara-shi, Nara, Japan, 634 8522
- Novo Nordisk Investigational Site
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Kawasaki-shi, Kanagawa, Japan, 216-8511
- Novo Nordisk Investigational Site
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Nagoya-shi, Aichi, Japan, 466 8560
- Novo Nordisk Investigational Site
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Nishinomiya-shi, Japan, 663 8051
- Novo Nordisk Investigational Site
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Suginami-ku, Tokyo, Japan, 167 0035
- Novo Nordisk Investigational Site
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Tokyo, Japan, 108-8639
- Novo Nordisk Investigational Site
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Ankara, Kalkun, 06500
- Novo Nordisk Investigational Site
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Kayseri, Kalkun, 38010
- Novo Nordisk Investigational Site
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Konya, Kalkun, 42090
- Novo Nordisk Investigational Site
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Skopje, Makedonien, Den Tidligere Jugoslaviske Republik, 1000
- Novo Nordisk Investigational Site
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Kuala Lumpur, Malaysia, 50400
- Novo Nordisk Investigational Site
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Timis
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Timisoara, Timis, Rumænien, 300011
- Novo Nordisk Investigational Site
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Madrid, Spanien, 28046
- Novo Nordisk Investigational Site
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Valencia, Spanien, 46026
- Novo Nordisk Investigational Site
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Gauteng
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Parktown Johannesburg, Gauteng, Sydafrika, 2193
- Novo Nordisk Investigational Site
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Taipei, Taiwan, 100
- Novo Nordisk Investigational Site
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Bangkok, Thailand, 10400
- Novo Nordisk Investigational Site
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Bonn, Tyskland, 53127
- Novo Nordisk Investigational Site
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Duisburg, Tyskland, 47051
- Novo Nordisk Investigational Site
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Giessen, Tyskland, 35392
- Novo Nordisk Investigational Site
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Hannover, Tyskland, 30625
- Novo Nordisk Investigational Site
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Wien, Østrig, 1090
- Novo Nordisk Investigational Site
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patients with haemophilia B with a FIX activity below or equal to 2%
- Male patients with moderately severe or severe congenital haemophilia B with a FIX activity below or equal to 2% according to medical records
- History of at least 150 exposure days to other FIX products
- Scheduled major surgery
Exclusion Criteria:
- Known history of FIX (coagulation factor nine) inhibitors based on existing medical records, laboratory report reviews and patient and LAR (legal acceptable representative) interviews
- Current FIX (coagulation factor nine) inhibitors above or equal to 0.6 Bethesda Units (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 (alanine aminotransferase) 3 times the upper limit of normal reference ranges at screening (central laboratory)
- Immune modulating or chemotherapeutic medication
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Patients enrolled in trial
New patients will be included as well as transferred patients from Paradigm™ 2 or Paradigm™ 4 trial
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The patients will receive nonacog beta pegol at screening just prior to and during surgical intervention, administered intravenously (into the vein).
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Haemostatic Effect During Surgery Evaluated by the Four-point Response Scale (Excellent, Good, Moderate, Poor)
Tidsramme: At the day of surgery
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Haemostatic effect during surgery was evaluated immediately after surgery (last stitch) using a fourpoint response scale: - Four-point response scale: Excellent, good, moderate, poor. The evaluation was done by the surgeon, anaesthesiologist and/or investigator based on experience as follows:
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At the day of surgery
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Consumption of NNC-0156-0000-0009 (U/kg Body Weight)
Tidsramme: During surgery (the time from knife to skin until last stitch) and post-operative period (day 1 to day 13)
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Mean consumption of nonacog beta pegol (U/kg) used for treatment per patient before surgery, during surgery (the time from knife to skin until last stitch) and post-operative period.
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During surgery (the time from knife to skin until last stitch) and post-operative period (day 1 to day 13)
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Transfusion Requirements (Fulfilling Transfusion Criteria)
Tidsramme: during surgery (the time from knife to skin until last stitch) and post-operative period (day 1 to day 13)
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Mean quantity of transfusion during surgery (the time from knife to skin until last stitch) and the postoperative period (Day 1-13).None of the patients required transfusions beyond Day 6 hence no values presented for days 7-13.
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during surgery (the time from knife to skin until last stitch) and post-operative period (day 1 to day 13)
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Haemoglobin Pre- and Post-surgery Start
Tidsramme: 0, 1 hour, 24 hours.
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The mean pre-surgery and post surgery haemoglobin level.
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0, 1 hour, 24 hours.
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Incidence of Adverse Events (AEs)
Tidsramme: during the trial period (2-8 weeks prior to day of surgery (transferred subjects) or 2-4 weeks prior to day of surgery (new subjects) until 4 weeks after post-operative period (day 1 to day 13)
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The number of adverse events per patient years of exposure, reported during the trial period.
Number is the only available option here, the data presented are rate of AEs.
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during the trial period (2-8 weeks prior to day of surgery (transferred subjects) or 2-4 weeks prior to day of surgery (new subjects) until 4 weeks after post-operative period (day 1 to day 13)
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Incidence of Serious Adverse Events (SAE)
Tidsramme: During the trial period (2-8 weeks prior to day of surgery (transferred subjects) or 2-4 weeks prior to day of surgery (new subjects) until 4 weeks after post-operative period (day 1 to day 13)
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The number of serious adverse events per patient years of exposure, reported during the trial period.
Number is the only available option here, the data presented are rate of AEs.
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During the trial period (2-8 weeks prior to day of surgery (transferred subjects) or 2-4 weeks prior to day of surgery (new subjects) until 4 weeks after post-operative period (day 1 to day 13)
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Incidence of Inhibitors Against FIX (Coagulation Factor Nine)
Tidsramme: During the trial period (2-8 weeks prior to day of surgery (transferred subjects) or 2-4 weeks prior to day of surgery (new subjects) and every 4 weeks after post-operative period (day 1 to day 13)
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Number of patients with inhibitory antibodies
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During the trial period (2-8 weeks prior to day of surgery (transferred subjects) or 2-4 weeks prior to day of surgery (new subjects) and every 4 weeks after post-operative period (day 1 to day 13)
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- Escobar M, Colberg T, Karim F, Caliskan U, Chowdary P, Giangrande P, Giermasz A, Mancuso ME, Serban M, Tsay W, Zak M and Mahlangu J. Perioperative hemostatic management of major surgery in hemophilia B with long-acting recombinant glycopegylated factor IX: results from the paradigm™3 clinical trial. Journal of Thrombosis and Haemostasis (Abstracts) 2015; 13 (Supplement S2): 1-997 [OR348]
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NN7999-3773
- 2010-023070-40 (EudraCT nummer)
- U1111-1121-4554 (Anden identifikator: WHO)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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