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A phase 1/2 open-label, single ascending dose trial of a self-complementing optimized adeno-associated virus serotype 8 Factor IX gene therapy (AskBio009) in adults with haemophilia B

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Trial Profile

A phase 1/2 open-label, single ascending dose trial of a self-complementing optimized adeno-associated virus serotype 8 Factor IX gene therapy (AskBio009) in adults with haemophilia B

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 02 Feb 2024

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At a glance

  • Drugs AskBio 009 (Primary)
  • Indications Haemophilia B
  • Focus Adverse reactions; First in man
  • Sponsors Asklepios BioPharmaceutical; Baxalta; Baxter Healthcare Corporation; Shire

    • Most Recent Events

    • 29 Jan 2024 Planned End Date changed from 28 Oct 2030 to 17 Jan 2030.
    • 29 Jan 2024 Planned primary completion date changed from 28 Oct 2030 to 17 Jan 2030.
    • 13 Dec 2022 Results (n=8; data cutoff of May 6, 2022) assessing the long-term safety, participant disposition, persistence of endogenous FIX R338L transgene expression; and long term persistence of neutralizing anti-capsid antibodies, presented at the 64th American Society of Hematology Annual Meeting and Exposition.
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