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A Phase 3, Prospective, Randomized, Open-label, Adaptive Group Sequential, Multicenter Trial With Blinded Endpoint Assessment to Evaluate the Efficacy and Safety of TAK-330 for the Reversal of Direct Oral Factor Xa Inhibitor-induced Anticoagulation in Patients Requiring Urgent Surgery/Invasive Procedure

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Trial Profile

A Phase 3, Prospective, Randomized, Open-label, Adaptive Group Sequential, Multicenter Trial With Blinded Endpoint Assessment to Evaluate the Efficacy and Safety of TAK-330 for the Reversal of Direct Oral Factor Xa Inhibitor-induced Anticoagulation in Patients Requiring Urgent Surgery/Invasive Procedure

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 03 Apr 2024

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At a glance

  • Drugs Prothrombin complex concentrate (Primary)
  • Indications Blood coagulation disorders; Postoperative haemorrhage
  • Focus Registrational; Therapeutic Use
  • Sponsors Takeda; Takeda Development Center Americas
  • Most Recent Events

    • 13 Oct 2022 Planned End Date changed from 31 May 2025 to 30 Nov 2025.
    • 13 Oct 2022 Planned primary completion date changed from 31 May 2025 to 30 Nov 2025.
    • 10 Oct 2022 Planned End Date changed from 30 Jun 2023 to 31 May 2025.
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