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A Phase 3, Prospective, Randomized, Controlled, Open-label, Multicenter, 2 Period Crossover Study With a Single Arm Continuation Evaluating the Safety And Efficacy of BAX 930 (rADAMTS13) in the Prophylactic And On-demand Treatment of Subjects With Severe Congenital Thrombotic Thrombocytopenic Purpura (cTTP, Upshaw-Schulman Syndrome [USS], Hereditary Thrombotic Thrombocytopenic Purpura [hTTP])

Trial Profile

A Phase 3, Prospective, Randomized, Controlled, Open-label, Multicenter, 2 Period Crossover Study With a Single Arm Continuation Evaluating the Safety And Efficacy of BAX 930 (rADAMTS13) in the Prophylactic And On-demand Treatment of Subjects With Severe Congenital Thrombotic Thrombocytopenic Purpura (cTTP, Upshaw-Schulman Syndrome [USS], Hereditary Thrombotic Thrombocytopenic Purpura [hTTP])

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 28 Mar 2024

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At a glance

  • Drugs Apadamtase alfa (Primary) ; Plasma
  • Indications Thrombotic thrombocytopenic purpura
  • Focus Registrational; Therapeutic Use
  • Sponsors Baxalta; Shire; Takeda
  • Most Recent Events

    • 26 Mar 2024 According to a Takeda media release, base on results from NCT03393975 and NCT04683003, the Japanese Ministry of Health, Labour and Welfare has approved the use of ADZYNMA (apadamtase alfa /cinaxadamtase alfa) for the treatment of congenital thrombotic thrombocytopenic purpura (cTTP) for individuals 12 years of age and older.
    • 26 Feb 2024 Planned End Date changed from 19 Jan 2024 to 28 Jun 2024.
    • 26 Feb 2024 Planned primary completion date changed from 19 Jan 2024 to 28 Jun 2024.
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