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

ConditionCoagulation Disorder
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorTakeda

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 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

440 Participants
are divided into 2 treatment groups
Group A: TAK-330 25 IU/kgExperimental treatment 1 intervention
Group B: SOC 4F-PCCActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of Participants With Intraoperative Effective Hemostasis

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.

Time frame
At the end of the surgery/procedure

Secondary outcomes

1

Percentage of Participants With Postoperative Effective Hemostasis

Percentage of participants achieving postoperative effective hemostasis at 24±4 hours following the completion of investigational product infusion, as determined by the Postoperative Four Point Hemostatic Efficacy Scale and assessed by the PI, the surgeon, or a qualified member of the surgical team.

Time frame
At 24 hours after the end of investigational product infusion
2

Percentage of Participants With Intraoperative Effective Hemostasis Based on Hemostatic Efficacy Rating Algorithm

Percentage of participants achieving intraoperative effective hemostasis, as determined by the Hemostatic Efficacy Rating Algorithm and assessed by the PI, the surgeon, or a qualified member of the surgical team.

Time frame
At the end of the surgery/procedure
3

Number of Participants With Usage of Blood Products or Non-Study Hemostatic Agents for Bleeding Control

Number of participants with usage of blood products or non-study hemostatic agents for bleeding control will be documented from the end of IP infusion to 24 hours after end of study product infusion.

Time frame
Within 24 hours after the end of investigational product infusion
4

Number of Units of Packed Red Blood Cells (PRBCs) Administered to Achieve Bleeding Control

Number of units of PRBCs administered to achieve bleeding control within 24 hours after the end of IP infusion.

Time frame
Within 24 hours after the end of investigational product infusion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Takeda

Lead sponsor

Takeda Development Center Americas, Inc.

Collaborator

Source ClinicalTrials.gov
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