Clinical Trial

A Study of TAK-330 to Reverse the Effects of Factor Xa Inhibitors For Adults Needing Urgent Surgery

Recruiting Phase 3
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Summary
The aim of this study is to find out the effects of TAK-330 compared with four-factor prothrombin complex concentrate (4F-PCC) as part of standard treatment other than Prothromplex Total for anticoagulation reversal in participants treated with Factor Xa inhibitors who require urgent surgery/invasive procedure. The participant will be assigned by chance to either TAK-330 or SOC 4F-PCC as part of standard treatment before surgery. Patients participating in this study will need to be hospitalized. They will also be contacted (via telehealth/phone call) 30 days after the surgery.
Protocol Amendment History 3 changes
notable Enrollment increased: 328 -> 440 participants 2026-06-19
notable Primary completion pushed: 2028-04-12 -> 2028-08-30 2026-06-19
minor Completion pushed: 2028-04-12 -> 2028-08-30 2026-06-19
Trial Details
NCT Number NCT05156983
Lead Sponsor Takeda
Collaborators: Takeda Development Center Americas, Inc.
Conditions Coagulation Disorder
Enrollment 440 participants
Start Date 2022-08-24
Primary Completion 2028-08-30 (estimated)
Study Completion 2028-08-30 (estimated)
Updated on ClinicalTrials.gov 2026-06-18