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Efficacy and Safety of NNC-0156-0000-0009 During Surgical Procedures in Subjects With Haemophilia B (paradigm™ 3)

24. juli 2017 oppdatert av: Novo Nordisk A/S

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

13

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • California
      • Los Angeles, California, Forente stater, 90027
        • Novo Nordisk Investigational Site
      • San Francisco, California, Forente stater, 94143
        • Novo Nordisk Investigational Site
    • District of Columbia
      • Washington, D.C., District of Columbia, Forente stater, 20007
        • Novo Nordisk Investigational Site
    • Georgia
      • Augusta, Georgia, Forente stater, 30912
        • Novo Nordisk Investigational Site
    • Iowa
      • Iowa City, Iowa, Forente stater, 52242
        • Novo Nordisk Investigational Site
    • New York
      • Syracuse, New York, Forente stater, 13210
        • Novo Nordisk Investigational Site
    • Texas
      • Houston, Texas, Forente stater, 77030
        • Novo Nordisk Investigational Site
  • Frankrike
      • Kremlin-Bicêtre, Frankrike, 94270
        • Novo Nordisk Investigational Site
      • Lyon, Frankrike, 69003
        • Novo Nordisk Investigational Site
  • Hellas
      • Athens, Hellas, GR-11527
        • Novo Nordisk Investigational Site
  • Italia
      • Firenze, Italia, 50134
        • Novo Nordisk Investigational Site
      • Milano, Italia, 20124
        • Novo Nordisk Investigational Site
  • Japan
      • Kashihara-shi, Nara, Japan, 634 8522
        • Novo Nordisk Investigational Site
      • Kawasaki-shi, Kanagawa, Japan, 216-8511
        • Novo Nordisk Investigational Site
      • Nagoya-shi, Aichi, Japan, 466 8560
        • Novo Nordisk Investigational Site
      • Nishinomiya-shi, Japan, 663 8051
        • Novo Nordisk Investigational Site
      • Suginami-ku, Tokyo, Japan, 167 0035
        • Novo Nordisk Investigational Site
      • Tokyo, Japan, 108-8639
        • Novo Nordisk Investigational Site
  • Makedonia, Den tidligere jugoslaviske republikken
      • Skopje, Makedonia, Den tidligere jugoslaviske republikken, 1000
        • Novo Nordisk Investigational Site
  • Malaysia
      • Kuala Lumpur, Malaysia, 50400
        • Novo Nordisk Investigational Site
  • Nederland
      • Utrecht, Nederland, 3584 CX
        • Novo Nordisk Investigational Site
  • Romania
    • Timis
      • Timisoara, Timis, Romania, 300011
        • Novo Nordisk Investigational Site
  • Spania
      • Madrid, Spania, 28046
        • Novo Nordisk Investigational Site
      • Valencia, Spania, 46026
        • Novo Nordisk Investigational Site
  • Storbritannia
      • Basingstoke, Storbritannia, RG24 9NA
        • Novo Nordisk Investigational Site
      • Cardiff, Storbritannia, CF14 4XW
        • Novo Nordisk Investigational Site
      • London, Storbritannia, NW3 2QG
        • Novo Nordisk Investigational Site
      • London, Storbritannia, SE1 7EH
        • Novo Nordisk Investigational Site
      • Manchester, Storbritannia, M13 9WL
        • Novo Nordisk Investigational Site
      • Oxford, Storbritannia, OX3 7LJ
        • Novo Nordisk Investigational Site
  • Sør-Afrika
    • Gauteng
      • Parktown Johannesburg, Gauteng, Sør-Afrika, 2193
        • Novo Nordisk Investigational Site
  • Taiwan
      • Taipei, Taiwan, 100
        • Novo Nordisk Investigational Site
  • Thailand
      • Bangkok, Thailand, 10400
        • Novo Nordisk Investigational Site
  • Tyrkia
      • Ankara, Tyrkia, 06500
        • Novo Nordisk Investigational Site
      • Kayseri, Tyrkia, 38010
        • Novo Nordisk Investigational Site
      • Konya, Tyrkia, 42090
        • Novo Nordisk Investigational Site
  • Tyskland
      • Bonn, Tyskland, 53127
        • Novo Nordisk Investigational Site
      • Duisburg, Tyskland, 47051
        • Novo Nordisk Investigational Site
      • Giessen, Tyskland, 35392
        • Novo Nordisk Investigational Site
      • Hannover, Tyskland, 30625
        • Novo Nordisk Investigational Site
  • Østerrike
      • Wien, Østerrike, 1090
        • Novo Nordisk Investigational Site

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

13 år til 70 år (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Mann

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Patients enrolled in trial
New patients will be included as well as transferred patients from Paradigm™ 2 or Paradigm™ 4 trial
Legemiddel: nonacog beta pegol
The patients will receive nonacog beta pegol at screening just prior to and during surgical intervention, administered intravenously (into the vein).
Andre navn:
  • NNC-0156-0000-0009

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Haemostatic Effect During Surgery Evaluated by the Four-point Response Scale (Excellent, Good, Moderate, Poor)
Tidsramme: At the day of surgery

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:

  1. Excellent: Better than expected/predicted in this type of procedure.
  2. Good: As expected in this type of procedure.
  3. Moderate: Less than optimal for the type of procedure but haemostatic response maintained without change of treatment regimen.
  4. Poor: Bleeding due to inadequate therapeutic response with adequate dosing, change of regimen required.
At the day of surgery

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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)
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.
During surgery (the time from knife to skin until last stitch) and post-operative period (day 1 to day 13)
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)
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.
during surgery (the time from knife to skin until last stitch) and post-operative period (day 1 to day 13)
Haemoglobin Pre- and Post-surgery Start
Tidsramme: 0, 1 hour, 24 hours.
The mean pre-surgery and post surgery haemoglobin level.
0, 1 hour, 24 hours.
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)
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.
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)
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)
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.
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)
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)
Number of patients with inhibitory antibodies
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)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Novo Nordisk A/S

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

  • 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]

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

7. juni 2012

Primær fullføring (Faktiske)

1. desember 2013

Studiet fullført (Faktiske)

1. desember 2013

Datoer for studieregistrering

Først innsendt

30. juni 2011

Først innsendt som oppfylte QC-kriteriene

30. juni 2011

Først lagt ut (Anslag)

1. juli 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

23. august 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

24. juli 2017

Sist bekreftet

1. juli 2017

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • NN7999-3773
  • 2010-023070-40 (EudraCT-nummer)
  • U1111-1121-4554 (Annen identifikator: WHO)

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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