Trials / Recruiting
RecruitingNCT05156983
A Study of TAK-330 to Reverse the Effects of Factor Xa Inhibitors For Adults Needing Urgent Surgery
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
- Phase 3
- Study type
- Interventional
- Enrollment
- 328 (estimated)
- Sponsor
- Takeda · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TAK-330 | Participants will receive TAK-330, 25 IU/kg single intravenous infusion on Day 1 and an additional dose of 25 IU/kg TAK-330 can be administered if required. |
| DRUG | SOC 4F-PCC | Participants will receive 4F-PCC as SOC on Day 1. The dose and infusion speed of the SOC 4F-PCC will be based on local institutional protocols. An additional dose of SOC 4F-PCC not exceeding total dose of 50 IU/kg or 5,000 IU, whichever is smaller can be given during the surgery if required. |
Timeline
- Start date
- 2022-08-24
- Primary completion
- 2028-04-12
- Completion
- 2028-04-12
- First posted
- 2021-12-14
- Last updated
- 2026-01-28
Locations
64 sites across 15 countries: United States, Argentina, Austria, Belgium, Brazil, Canada, Czechia, France, Germany, Greece, Hungary, Israel, Poland, Portugal, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05156983. Inclusion in this directory is not an endorsement.