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A Global, Open-Label, Multicenter, Phase 1/2 Study of the Safety and Dose Escalation of BAX 888, an Adeno-Associated Virus Serotype 8 (AAV8) Vector Expressing B-Domain Deleted Factor VIII (BDD-FVIII) in Severe Hemophilia A Subjects Administered a Single Intravenous Infusion

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Trial Profile

A Global, Open-Label, Multicenter, Phase 1/2 Study of the Safety and Dose Escalation of BAX 888, an Adeno-Associated Virus Serotype 8 (AAV8) Vector Expressing B-Domain Deleted Factor VIII (BDD-FVIII) in Severe Hemophilia A Subjects Administered a Single Intravenous Infusion

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 07 Oct 2025

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At a glance

  • Drugs TAK 754 (Primary)
  • Indications Haemophilia A
  • Focus Adverse reactions; First in man
  • Sponsors Baxalta; Shire; Takeda

Most Recent Events

  • 08 Sep 2025 Protocol has been amended to remove one arm (Experimental: Cohort 3) , it has been changed from 3 to 2.
  • 15 Apr 2025 Status changed from active, no longer recruiting to completed.
  • 01 Jan 2025 Clinical and translational results of the first two cohorts treated with TAK 754 were published in the Haemophilia.

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