Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival ( TAP Study )
A Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Large Simple Trial Evaluating the Use of BE1116 (4-Factor Prothrombin Complex Concentrate [Kcentra® / Beriplex®]) to Improve Survival in Patients With Traumatic Injury and Acute Major Bleeding
Sponsor: CSL Behring
Terminated
Study was terminated early because mortality was lower than expected and a significant increase in sample size would have been required to meet statistical goals of the study. No safety reasons were involved in the decision to terminate the study.
This PHASE3 trial investigates Traumatic Injury and is currently terminated or withdrawn. CSL Behring leads this study, which shows 19 recorded versions since 2023 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Status Flow
Change History
19 versions recorded-
Jan 2026 — Present [monthly]
Terminated PHASE3
-
Dec 2025 — Jan 2026 [monthly]
Terminated PHASE3
-
Sep 2025 — Dec 2025 [monthly]
Terminated PHASE3
-
Dec 2024 — Sep 2025 [monthly]
Terminated PHASE3
Status: Recruiting → Terminated
-
Sep 2024 — Dec 2024 [monthly]
Recruiting PHASE3
▶ Show 14 earlier versions
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Jul 2024 — Sep 2024 [monthly]
Recruiting PHASE3
-
Jun 2024 — Jul 2024 [monthly]
Recruiting PHASE3
-
Apr 2024 — Jun 2024 [monthly]
Recruiting PHASE3
-
Feb 2024 — Apr 2024 [monthly]
Recruiting PHASE3
-
Dec 2023 — Feb 2024 [monthly]
Recruiting PHASE3
-
Nov 2023 — Dec 2023 [monthly]
Recruiting PHASE3
-
Oct 2023 — Nov 2023 [monthly]
Recruiting PHASE3
-
Sep 2023 — Oct 2023 [monthly]
Recruiting PHASE3
-
Aug 2023 — Sep 2023 [monthly]
Recruiting PHASE3
-
Jul 2023 — Aug 2023 [monthly]
Recruiting PHASE3
-
Jun 2023 — Jul 2023 [monthly]
Recruiting PHASE3
-
May 2023 — Jun 2023 [monthly]
Recruiting PHASE3
Status: Active Not Recruiting → Recruiting
-
Apr 2023 — May 2023 [monthly]
Active Not Recruiting PHASE3
Status: Not Yet Recruiting → Active Not Recruiting
-
Nov 2022 — Apr 2023 [monthly]
Not Yet Recruiting PHASE3
First recorded
Eligibility Summary
No eligibility information available.
Contact Information
- CSL Behring
For direct contact, visit the study record on ClinicalTrials.gov .