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
Latest Information Update: 02 Oct 2024
At a glance
- Drugs Prothrombin complex concentrate (Primary)
- Indications Blood coagulation disorders; Postoperative haemorrhage
- Focus Registrational; Therapeutic Use
- Sponsors Takeda; Takeda Development Center Americas
- 18 Jul 2024 Planned End Date changed from 30 Nov 2025 to 12 Apr 2028.
- 18 Jul 2024 Planned primary completion date changed from 30 Nov 2025 to 12 Apr 2028.
- 13 Oct 2022 Planned End Date changed from 31 May 2025 to 30 Nov 2025.