drugset / Trial / NCT05568888
Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival ( TAP Study )
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2023-03-28
- Primary completion
- 2024-10-29
- Completion
- 2024-10-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BE1116 | Protein / enzyme biologic | — | Intravenous |
Indications
No indication recorded.