Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TAK-330 · 1 trial · 1 indication
Percentage of participants achieving intraoperative effective hemostasis, as determined by the Intraoperative Four Point Hemostatic Efficacy Scale and assessed by the principal investigator (PI), the surgeon, or a qualified member of the surgical team.
| Arm | Type | Description |
|---|---|---|
| TAK-330 25 IU/kg | EXPERIMENTAL | Participants will receive TAK-330, 25 international unit per kilogram (IU/kg) single intravenous infusion on Day 1 (prior to surgery) as an initial dose and an additional dose of 25 IU/kg TAK-330 can be administered during the surgery if deemed necessary by the surgeon. The total dose of TAK-330 administered to the participant should not exceed 50 IU/kg or 5,000 IU, whichever is smaller. |
| SOC 4F-PCC | ACTIVE_COMPARATOR | Participants will receive 4F-PCC (excluding Prothromplex Total and activated 4F-PCC) as standard of care (SOC) on Day 1 (prior to surgery). 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. |
| Name | Type | Description |
|---|---|---|
| TAK-330 | DRUG | 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. |
| SOC 4F-PCC | DRUG | 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. |
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Boston Scientific Corporation | BSX | 3 | N/A | Undisclosed |
| Abbott Laboratories | ABT | 2 | - | Undisclosed |
| Cerus Corporation | CERS | 1 | - | Pathogen Reduced Cryoprecipitated Fibrinogen Complex |
TAK-330 is an investigational small molecule being developed for coagulation disorders. It is studied to reverse the effects of Factor Xa inhibitors in adults needing urgent surgery. The drug is in Phase 3 clinical development and is not yet approved by regulatory authorities.
TAK-330 is designed to reverse the effects of Factor Xa inhibitors, which are anticoagulant medications. By counteracting these inhibitors, TAK-330 aims to restore normal blood clotting in patients who require urgent surgery. This mechanism is being evaluated in a Phase 3 clinical trial.
TAK-330 is being developed by Takeda Pharmaceutical Company Limited, a global biopharmaceutical company. Takeda is conducting a Phase 3 clinical trial to evaluate the drug's safety and efficacy in reversing Factor Xa inhibitor effects in adults needing urgent surgery.
TAK-330 is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies. The ongoing Phase 3 trial is recruiting participants to assess its effectiveness in reversing Factor Xa inhibitors for urgent surgery.
TAK-330 is being studied in a Phase 3 clinical trial with the identifier NCT05156983. This randomized, double-blind, active-controlled study enrolls 440 adults with coagulation disorders who need urgent surgery. The trial is recruiting participants across multiple countries, including the United States and several European nations.
TAK-330 is a unique investigational compound developed by Takeda. No alternative names have been reported for this drug. It is being studied specifically for its potential to reverse the effects of Factor Xa inhibitors in patients requiring urgent surgery.