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

Part of paid clinical trials in Arkansas City, Arkansas.

Sponsor
Takeda
Study ID
NCT05156983
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Coagulation Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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 Dates

Start date
Aug 24, 2022
Status verified
Jan 2026
Primary completion
Apr 12, 2028
Completion
Apr 12, 2028

Study Design

Enrollment
328 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
University of Arkansas Medical SciencesArkansas CityArkansas72205-
University of California Davis Health SystemSacramentoCalifornia95817-
Denver Metro Orthopedics, P.C.EnglewoodColorado80012-
University of FloridaGainesvilleFlorida32608-
Rutgers, The State University of New JerseyNew BrunswickNew Jersey07103-
ECU Health Medical CenterGreenvilleNorth Carolina27858-
Metro Health Medical CenterClevelandOhio44109-
Ohio State UniversityColumbusOhio43210-
Ascension St. John Medical CenterTulsaOklahoma74104-
University of Pennsylvania - Perelman School of MedicinePhiladelphiaPennsylvania19104-
UPMCPittsburghPennsylvania15213-
University of Texas Southwestern Medical CenterDallasTexas75390-
Carilion Medical CenterVirginia BeachVirginia24014-

Find similar trials in Arkansas City, AR

By research site
University of Arkansas Medical Sciences· Arkansas City, ARUniversity of California Davis Health System· Sacramento, CADenver Metro Orthopedics, P.C.· Englewood, COUniversity of Florida· Gainesville, FLRutgers, The State University of New Jersey· New Brunswick, NJECU Health Medical Center· Greenville, NC

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