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Safety, Efficacy and Pharmacokinetics of NNC-0156-0000-0009 in Previously Treated Children With Haemophilia B

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Trial Profile

Safety, Efficacy and Pharmacokinetics of NNC-0156-0000-0009 in Previously Treated Children With Haemophilia B

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 30 Jan 2025

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At a glance

  • Drugs Nonacog beta pegol (Primary)
  • Indications Haemophilia B
  • Focus Adverse reactions; Registrational
  • Acronyms paradigm 5
  • Sponsors Novo Nordisk

Most Recent Events

  • 26 Dec 2023 Status changed from active, no longer recruiting to completed.
  • 13 Aug 2021 Planned primary completion date changed from 1 Apr 2014 to 30 Nov 2023.
  • 01 May 2020 Results (data cut off: October 1, 2018) assessing long-term safety and efficacy data from the paradigm 5 trial after a minimum of 5 years of follow-up and compare results with the 1-year analysis published in the Thrombosis and Haemostasis

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