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A Phase 1/2a, Open-Label, Dose-Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of a Single Intravenous Injection of rFVIIIFc-VWF-XTEN (BIVV001) in Previously Treated Adults With Severe Hemophilia A

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Trial Profile

A Phase 1/2a, Open-Label, Dose-Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of a Single Intravenous Injection of rFVIIIFc-VWF-XTEN (BIVV001) in Previously Treated Adults With Severe Hemophilia A

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 17 Jan 2023

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At a glance

  • Drugs Efanesoctocog alfa (Primary) ; Octocog alfa
  • Indications Haemophilia A
  • Focus Adverse reactions
  • Acronyms EXTEN-A
  • Sponsors Bioverativ

    • Most Recent Events

    • 13 Dec 2022 Population Pharmacokinetic (PopPK) analysis performed by using blood samples from 5 clinical studies(NCT03205163, EudraCT 2018-001535-51, NCT04161495, NCT04759131 and NCT04644575) presented at the 64th American Society of Hematology Annual Meeting and Exposition.
    • 14 Dec 2021 Results presented at the 63rd American Society of Hematology Annual Meeting and Exposition
    • 14 Dec 2021 Results of a post hoc analysis is assessed the relationship between endogenous VWF antigen levels and efanesoctocog alfa half-life and clearance in patients with severe hemophilia A from the single- and repeat-dosing studies presented at the 63rd American Society of Hematology Annual Meeting and Exposition
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