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Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival ( TAP Study )

Terminated · Phase 3 · NCT05568888

Conditions: Traumatic Injury

At a glance

Research payments reported, 2025
$2.5M
U.S. investigators named
78
Sites paid
76
Planned or actual enrollment
1,366

About the trial

Sponsor
CSL Behring
Tested
BE1116 (drug), Placebo (drug)
Dates
Started 2023-03-28; completion 2024-10-29
Results posted
Yes

This is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group, large simple trial to investigate the efficacy and safety of a single intravenous (IV) infusion of BE1116 in subjects who have traumatic injury, with confirmed or suspected acute major bleeding and / or predicted to receive a large volume blood product transfusion.

From ClinicalTrials.gov, last updated 2025-12-10. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Csl Behring reported $2.5M in research payments for this study in 2025 (601 payments).

Products named: Kcentra

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.

U.S. investigators named on this study

Clinicians the company named as principal investigators in its Open Payments reports.

Sites paid to run it

Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.