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

Recruiting now · Phase 3

Conditions studied: Coagulation Disorder

In brief

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.

Key facts

Study ID

NCT05156983

Run by

Takeda

People needed

440

Starts

2022-08-24

Expected to finish

2028-08-30

Last updated by the study team

2026-06-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of California Davis Health System — Sacramento, California, United States (enrolling)
• Denver Metro Orthopedics, P.C. — Englewood, Colorado, United States (enrolling)
• University of Florida — Gainesville, Florida, United States (enrolling)
• Rutgers, The State University of New Jersey — New Brunswick, New Jersey, United States (enrolling)
• ECU Health Medical Center — Greenville, North Carolina, United States (enrolling)
• Metro Health Medical Center — Cleveland, Ohio, United States (enrolling)
• Ohio State University — Columbus, Ohio, United States (enrolling)
• Ascension St. John Medical Center — Tulsa, Oklahoma, United States (enrolling)
• University of Pennsylvania - Perelman School of Medicine — Philadelphia, Pennsylvania, United States (enrolling)
• UPMC — Pittsburgh, Pennsylvania, United States (enrolling)
• University of Texas Southwestern Medical Center — Dallas, Texas, United States (enrolling)
• Carilion Medical Center — Virginia Beach, Virginia, United States (enrolling)
• Hospital Universitario Austral — Buenos Aires, Argentina (enrolling)
• Clinica Zabala — Ciudad Autonoma Buenos Aires, Argentina (enrolling)
• Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia - FLENI — Ciudad Autonoma Buenos Aires, Argentina (enrolling)
• Hospital Privado de Rosario — Santa Fe, Argentina (enrolling)
• LKH - Universitaetsklinikum Graz — Graz, Austria (enrolling)
• Landesklinikum Neunkirchen — Neunkirchen, Austria (enrolling)
• ZOL — Genk, Limburg, Belgium (enrolling)
• Jessa Ziekenhuis Hospital — Hasselt, Limburg, Belgium (enrolling)
• AZ Groeninge — Kortrijk, Belgium (enrolling)
• CHU UCL Namur — Therasse 1, Belgium (enrolling)
• Irmandade da Santa Casa da Misericordia de Santos — Santos, São Paulo, Brazil (enrolling)
• Hospital de Clinicas de Ijui — Ijuí, Brazil (enrolling)
• University of Arkansas Medical Sciences — Arkansas City, Arkansas, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.