Trials / Terminated
TerminatedNCT05568888
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
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,366 (actual)
- Sponsor
- CSL Behring · Industry
- Sex
- All
- Age
- 15 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BE1116 | 4-Factor Prothrombin Complex administered by intravenous (IV) infusion |
| DRUG | Placebo | Administered by IV infusion |
Timeline
- Start date
- 2023-03-28
- Primary completion
- 2024-10-29
- Completion
- 2024-10-29
- First posted
- 2022-10-06
- Last updated
- 2025-12-10
- Results posted
- 2025-11-10
Locations
113 sites across 3 countries: United States, Australia, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05568888. Inclusion in this directory is not an endorsement.