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

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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