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

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)

Completed
Phase of Trial: Phase I

Latest Information Update: 22 Mar 2017

At a glance

  • Drugs BAX 930 (Primary)
  • Indications Thrombotic thrombocytopenic purpura
  • Focus Adverse reactions; First in man
  • Sponsors Baxalta; Baxter Healthcare Corporation
  • Most Recent Events

    • 07 Jun 2017 Biomarkers information updated
    • 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.
    • 06 Dec 2016 Results of pharmacodynamic activity in vivo presented at the 58th Annual Meeting and Exposition of the American Society of Hematology
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