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New treatment option for Coagulation Disorder
Official title A Study of TAK-330 to Reverse the Effects of Factor Xa Inhibitors For Adults Needing Urgent Surgery
ClinicalTrials.gov ID: NCT05156983
What this study is testing
What is TAK-330?
TAK-330 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for coagulation disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Women of childbearing potential should have a negative pregnancy test documented prior to enrollment.
You likely can't join 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...
- Active major bleeding defined as bleeding that requires surgery or transfusion of \>2 units of packed red blood cell (PRBC) or intracranial...
- 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...
- Known bleeding disorder (example, platelet function disorders, hemophilia, Von Willebrand disease, or coagulation factor deficiency).
See the full eligibility 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...
- Women of childbearing potential should have a negative pregnancy test documented prior to enrollment.
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- The use of PROTHROMPLEX TOTAL as SOC 4F-PCC.
- Women who are breastfeeding at the time of enrollment.
The study team makes the final eligibility decision.
Where it's taking place
- Arkansas City, Arkansas, United States
- Sacramento, California, United States
- Englewood, Colorado, United States
- Gainesville, Florida, United States
- New Brunswick, New Jersey, United States
- Greenville, North Carolina, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Tulsa, Oklahoma, United States
- Philadelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Dallas, Texas, United States
- Virginia Beach, Virginia, United States
- Buenos Aires, Argentina
- Ciudad Autonoma Buenos Aires, Argentina
- Santa Fe, Argentina
- Graz, Austria
- Neunkirchen, Austria
- Genk, Limburg, Belgium
- Hasselt, Limburg, Belgium
+ 39 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Arkansas City, Arkansas, United States; Sacramento, California, United States; Englewood, Colorado, United States; Gainesville, Florida, United States; New Brunswick, New Jersey, United States; Greenville, North Carolina, United States and 53 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.