Recruiting
Phase 3

TAK-330 vs. 4F-PCC

Sponsor:

Takeda

Code:

NCT05156983

Conditions

Coagulation Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TAK-330

SOC 4F-PCC

Study Details

Brief 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

Coagulation Disorder

Study ID

NCT05156983

Start date

Aug 24, 2022

Status verified date

Jun, 2026

Completion date

Aug 30, 2028

Anticipated

Primary completion date

Aug 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 opinion of the surgeon, the participant requires an urgent surgery/procedure that is associated with high-risk of intraoperative bleeding within 15 hours from the last dose of Factor Xa inhibitor and requires a reversal agent for suspected direct oral Factor Xa inhibitor-related coagulopathy. For participants who are beyond the 15-hour window, eligibility requires proof of elevated plasma anti-Factor Xa (FXa) levels using either specific direct oral anti-coagulant (DOAC)-calibrated (apixaban, rivaroxaban or edoxaban) anti-FXa levels of greater than (>) 75 nanograms per milliliter (ng/mL), or heparin calibrated anti-FXa assay levels of >0.5 international unit per milliliter (IU/mL) at screening.
  • Women of childbearing potential should have a negative pregnancy test documented prior to enrollment.

Exclusion Criteria:

  • The participant has an expected survival of less than 30 days, even with best available medical and surgical care.
  • Recent history (within 90 days prior to screening) of venous thromboembolism, myocardial infarction (MI), disseminated intravascular coagulation (DIC), ischemic stroke, transient ischemic attack, hospitalization for unstable angina pectoris or severe or critical coronavirus 2 (SARS-CoV-2) infection.
  • Active major bleeding defined as bleeding that requires surgery or transfusion of >2 units of packed red blood cell (PRBC) or intracranial hemorrhage with the exception of subacute and chronic subdural hemorrhages with a Glasgow Coma Score (GCS) greater than or equal to (>=) 9.
  • Polytrauma for which reversal of Factor Xa-inhibition alone would not be sufficient to achieve hemostasis.
  • Known prothrombotic disorder including primary antiphospholipid syndrome, antithrombin-3 deficiency, homozygous protein C deficiency, homozygous protein S deficiency, and homozygous factor V Leiden.
  • Known bleeding disorder (example, platelet function disorders, hemophilia, Von Willebrand disease, or coagulation factor deficiency).
  • Platelet count less than (<) 50,000 per microliter (/mcL).
  • History of heparin-induced thrombocytopenia.
  • Administration of procoagulant drugs (example, non-study prothrombin complex concentrates (PCCs), recombinant Factor VIIa) or blood products (transfusion of whole blood, fresh frozen plasma, cryoglobulins, plasma fractions, or platelets) within 7 days before enrollment. (Note: administration of PRBCs for hemoglobin correction, tranexamic acid or aminocaproic acid are not exclusion criteria).
  • Planned use of procoagulant drugs (example, Vitamin K, non-study PCCs, recombinant Factor VIIa) or blood products (transfusion of whole blood, fresh frozen plasma, cryoglobulins, plasma fractions, or platelets) after enrollment but before the 24±4 hours hemostatic assessment (Key secondary endpoint). Planned administration of tranexamic acid (TXA) or aminocaproic acid after randomization but before the start of IP infusion, should be noted during randomization to properly stratify these participants in the interactive response technology (IRT). Planned administration of TXA or aminocaproic acid after start of IP infusion but before the 24±4 hours hemostatic assessment is prohibited. Administration of any of the above products before the 24±4 hours hemostatic assessment will impact the assessment of hemostasis. Administration of PRBCs for hemoglobin correction, is not an exclusion criterion.
  • Administration of unfractionated heparin within 2 hours before randomization or low molecular weight heparin within 6 hours before randomization.
  • Hypersensitivity to PCC constituents or any excipient of TAK-330.
  • Participants with history of confirmed immunoglobulin A (IgA) deficiency with hypersensitivity reaction and antibodies to IgA.
  • Septic shock as defined by persistent hypotension requiring vasopressors to maintain mean arterial pressure (MAP) >=65 millimeters of mercury (mmHg) and having blood lactate >2 millimole (mmol) despite adequate volume resuscitation.
  • Acute or chronic liver failure (hepatic cirrhosis Child-PUGH score C)
  • Renal failure requiring dialysis
  • Any other condition that could, in the opinion of the investigator, put the participant at undue risk of harm if the participant were to participate in the study.
  • Participation in another clinical study involving an investigational product or device within 30 days prior to study enrollment, or planned participation in another clinical study involving an investigational product or device during the course of this study. Participation in an observational study is not an exclusion criterion.
  • The use of PROTHROMPLEX TOTAL as SOC 4F-PCC.
  • Women who are breastfeeding at the time of enrollment.

Study Design

Enrollment

440 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TAK-330 25 IU/kg

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.

active comparator: SOC 4F-PCC

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.

Interventions

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.

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.

Primary outcome measure

  • Percentage of Participants With Intraoperative Effective Hemostasis [ Time Frame: At the end of the surgery/procedure ]

Central Contacts and Locations

Central contacts

Takeda Contact

+1-877-825-3327medinfoUS@takeda.com

Locations

University of Arkansas Medical Sciences

Recruiting

Arkansas City, Arkansas, United States, 72205

University of California Davis Health System

Recruiting

Sacramento, California, United States, 95817

Denver Metro Orthopedics, P.C.

Recruiting

Englewood, Colorado, United States, 80012

University of Florida

Recruiting

Gainesville, Florida, United States, 32608

Rutgers, The State University of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 07103

ECU Health Medical Center

Recruiting

Greenville, North Carolina, United States, 27858

Metro Health Medical Center

Recruiting

Cleveland, Ohio, United States, 44109

Ohio State University

Recruiting

Columbus, Ohio, United States, 43210

Ascension St. John Medical Center

Recruiting

Tulsa, Oklahoma, United States, 74104

University of Pennsylvania - Perelman School of Medicine

Recruiting

Philadelphia, Pennsylvania, United States, 19104

UPMC

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Carilion Medical Center

Recruiting

Virginia Beach, Virginia, United States, 24014

Hamilton General Hospital

Recruiting

Hamilton, Ontario, Canada, L8L 2X2

London Health Sciences Centre (LHSC) - University Hospital

Recruiting

London, Ontario, Canada, N6A 5A5

Unity Health Toronto St Michaels Hospital

Recruiting

Toronto, Ontario, Canada, M5N 1W8

Montreal General Hospital

Recruiting

Montreal, Quebec, Canada, H3G 1A4

The Ottawa Hospital - General Campus

Recruiting

Ontario, Canada, K1H 8L6

CHU de Quebec- Hopital de l Enfant Jesus

Recruiting

Québec, Canada, G1J-1Z4

More Information

Sponsor

Takeda

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Keywords

  • Reversal of Factor Xa inhibitors

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Takeda on 2026-06-18.