A Study of TAK-330 to Reverse the Effects of Factor Xa Inhibitors For Adults Needing Urgent Surgery
Recruiting
Phase 3
Interventional Study
Coagulation Disorder
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 440 (estimated)
- Sponsor
- Takeda · Industry
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About This Trial
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 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Participant or legally authorized representative willing to sign e-consent/written informed consent form.
* Participants at least 18 years of age at enrollment.
* Participant currently on treatment with oral Factor Xa inhibitor (rivaroxaban, apixaban, edoxaban).
* In the opini…
Contacts