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

> **NCT05568888** · PHASE3 · TERMINATED · sponsor: **CSL Behring** · enrollment: 1366 (actual)

## Conditions studied

- Traumatic Injury

## Interventions

- **DRUG:** BE1116
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT05568888
- **Lead sponsor:** CSL Behring
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2023-03-28
- **Primary completion:** 2024-10-29
- **Final completion:** 2024-10-29
- **Target enrollment:** 1366 (ACTUAL)
- **Why stopped:** 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.
- **Last updated:** 2025-12-10


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05568888

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05568888, "Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival ( TAP Study )". Retrieved via AI Analytics 2026-07-20 from https://api.ai-analytics.org/clinical/NCT05568888. Licensed CC0.

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