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BAX930 (rADAMTS13): A Phase 1 Prospective, Uncontrolled, Open-Label, Multicenter, Dose-Escalation Study Evaluating the Safety and Pharmacokinetics in Hereditary Thrombotic Thrombocytopenic Purpura (TTP)

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Trial Profile

BAX930 (rADAMTS13): A Phase 1 Prospective, Uncontrolled, Open-Label, Multicenter, Dose-Escalation Study Evaluating the Safety and Pharmacokinetics in Hereditary Thrombotic Thrombocytopenic Purpura (TTP)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 29 Jan 2024

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At a glance

  • Drugs Apadamtase alfa (Primary)
  • Indications Thrombotic thrombocytopenic purpura
  • Focus Adverse reactions; First in man
  • Sponsors Baxalta; Baxter Healthcare Corporation

    • Most Recent Events

    • 12 Dec 2023 Results of pooled analysis including data from phase 1 (NCT02216084), pivotal phase 3 (NCT03393975), and phase 3b continuation (NCT04683003) focusing on Pharmacokinetics and Exposure-Response Analyses, presented at the 65th American Society of Hematology Annual Meeting and Exposition.
    • 14 Sep 2017 Results published in the Blood
    • 22 Mar 2017 According to a Shire media release, based on data from this study United States Food and Drug Administration (FDA) has granted Fast Track designation for recombinant ADAMTS13 (SHP655 - historically known as BAX930) for treatment of acute episodes of hereditary thrombotic thrombocytopenic purpura (hTTP) in patients with a constitutional deficiency of ADAMTS13.

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