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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])

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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])

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Aug 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

    • 07 Aug 2024 According to a Takeda media release, Takeda receives European Commission Approval for ADZYNMA, based on the evidence provided by the interim analysis of this trial, as well as the continuation trial. This approval includes confirmation of orphan medicinal product designation and marks the first treatment specifically addressing the root cause of the disease - ADAMTS13 deficiency.
    • 10 Jun 2024 This trial has been completed in Germany, according to European Clinical Trials Database record.
    • 03 Jun 2024 Status changed from recruiting to completed.

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