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An Open-Label, Multicentre, Long-Term Follow-Up Study to Investigate the Safety and Durability of Response Following Dosing of a Novel Adeno-Associated Viral Vector (FLT180a) in Patients With Haemophilia B

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Trial Profile

An Open-Label, Multicentre, Long-Term Follow-Up Study to Investigate the Safety and Durability of Response Following Dosing of a Novel Adeno-Associated Viral Vector (FLT180a) in Patients With Haemophilia B

Status: Discontinued
Phase of Trial: Phase I/II

Latest Information Update: 24 Jul 2023

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At a glance

  • Drugs Verbrinacogene setparvovec (Primary)
  • Indications Haemophilia B
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Freeline Therapeutics

    • Most Recent Events

    • 18 Jul 2023 Status changed from active, no longer recruiting to discontinued.
    • 12 Jul 2022 Results (data cutoff date: 20 Sep 2021) reporting safety and efficacy data at median follow-up of 27.2 months from clinical trial NCT03369444 and its long term follow-up study NCT03641703 published in the New England Journal of Medicine
    • 30 Nov 2020 Status changed from recruiting to active, no longer recruiting.
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