A Phase 3 interventional study of BE1116 and Placebo in Traumatic Injury, sponsored by CSL Behring. Terminated at 113 sites in 3 countries. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2025-12-10.
Sponsored by CSL Behring · Phase 3, Interventional, and Treatment
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.
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's enrollment of 1,366 is above the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →CSL Behring is the lead sponsor of 142 studies on the registry; 18 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 17 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Administration by IV infusion
Drug: BE1116
Administration by IV infusion
Drug: Placebo
4-Factor Prothrombin Complex administered by intravenous (IV) infusion
Also known as: 4-Factor Prothrombin Complex, Kcentra®, Beriplex®
Administered by IV infusion
Proportion of Participants With All-cause 6-hour Mortality
Here, the percentage of participants with all-cause mortality has been reported. Percentages were rounded off if the second digit after the decimal point is equal to or more than five.
Time frame: Up to 6 hours after randomization
Proportion of Participants With All-cause 24-hour In-hospital Mortality
In-hospital mortality up to 24 hours after randomization was recorded and assessed for the primary hospitalization only. Here, the percentage of participants with all-cause in hospital mortality has been reported. Percentages were rounded off if the second digit after the decimal point is equal to or more than five.
Time frame: Up to 24 hours after randomization
Proportion of Participants With All-cause In-hospital Mortality Up to 30 Days After Randomization
In-hospital mortality was recorded and assessed for the primary hospitalization only. Here, the percentage of participants with all-cause in hospital mortality has been reported. Percentages were rounded off if the second digit after the decimal point is equal to or more than five.
Time frame: Up to 30 days after randomization
Proportion of Participants Who Underwent Surgical or Interventional Radiological Procedures to Stop Bleeding Related to the Primary Injury
Here, the percentage of participants with who underwent surgical or interventional radiological procedures to stop bleeding related to the primary injury has been reported. Percentages were rounded off if the second digit after the decimal point is equal to or more than five.
Time frame: Up to 24 hours after randomization
Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs)
The number of participants with treatment-emergent SAEs considered related to IP that occurred during primary hospitalization within the 30 days after randomization are summarized by treatment arm.
Time frame: Up to 30 days after randomization
Number of Participants With In-hospital Overall and Related Thromboembolic Events (TEEs)
The TEEs may be symptomatic or asymptomatic, and arterial or venous (eg, deep vein thrombosis, pulmonary embolism, ischemic stroke \[including thromboembolic stroke\], myocardial infarction). The observed in-hospital overall and related to IP TEEs are reported here.
Time frame: Up to 30 days after randomization
Number of Participants With Acute Respiratory Distress Syndrome (ARDS)
ARDS will be assessed using the Berlin definition based on four criteria: timing, chest imaging, origin of edema, oxygenation (mild, moderate or severe) and high-flow nasal oxygen.
Time frame: Up to 30 days after randomization
Number of Participants With Multiple Organ Failure
Multiple organ failure will be assessed using the Denver post injury multiple organ failure score. The Denver score rates the dysfunction of 4 organ systems (pulmonary, renal, hepatic, and cardiac), which are each graded on a scale from 0 to 3, where 0 represents "mild" and 3 was "severe". Multiple organ failure is defined as a score \> 3.
Time frame: Up to 30 days after randomization
Number of Participants With Acute Kidney Injury (AKI) Requiring Renal Replacement Therapy
Renal replacement therapy included dialysis, hemofiltration, or hemodiafiltration. AKI according to the Kidney Disease Improving Global Outcomes (KDIGO) guidelines is diagnosed if any one of the following happens: • Serum creatinine increases by ≥ 0.3 mg/dL (≥ 26.5 μmol/L) within 48 hours • Serum creatinine increases to ≥ 1.5 times the baseline level, within the past 7 days • Urine levels drops to less than 0.5 mL/kg/hour for 6 hours
Time frame: Up to 30 days after randomization
This study was conducted from 28 Mar 2023 to 29 October 2024 .
| Milestone | BE1116 | Placebo |
|---|---|---|
| Started | 689 | 677 |
| Treated | 618 | 627 |
| Completed | 628 | 605 |
| Not completed | 61 | 72 |
| Withdrew: Physician decision | 1 | 0 |
| Withdrew: Protocol deviation | 2 | 1 |
| Withdrew: Withdrawal by subject/legally authorized representative | 47 | 53 |
| Withdrew: Withdrawal by parent/guardian | 10 | 14 |
| Withdrew: No ip administered/subject excluded | 1 | 4 |
Here, the percentage of participants with all-cause mortality has been reported. Percentages were rounded off if the second digit after the decimal point is equal to or more than five.
| Percentage of participants | BE1116 | Placebo |
|---|---|---|
| All-cause Mortality in ITT Analysis Set | 7.3 | 4.6 |
| All-cause Mortality in mITT Analysis Set | 7.2 | 4.1 |
In-hospital mortality up to 24 hours after randomization was recorded and assessed for the primary hospitalization only. Here, the percentage of participants with all-cause in hospital mortality has been reported. Percentages were rounded off if the second digit after the decimal point is equal to or more than five.
| Percentage of participants | BE1116 | Placebo |
|---|---|---|
| Proportion of Participants With All-cause 24-hour In-hospital Mortality | 11.1 | 7.3 |
In-hospital mortality was recorded and assessed for the primary hospitalization only. Here, the percentage of participants with all-cause in hospital mortality has been reported. Percentages were rounded off if the second digit after the decimal point is equal to or more than five.
| Percentage of participants | BE1116 | Placebo |
|---|---|---|
| Proportion of Participants With All-cause In-hospital Mortality Up to 30 Days After Randomization | 24.8 | 18.6 |
Here, the percentage of participants with who underwent surgical or interventional radiological procedures to stop bleeding related to the primary injury has been reported. Percentages were rounded off if the second digit after the decimal point is equal to or more than five.
| Percentage of participants | BE1116 | Placebo |
|---|---|---|
| Proportion of Participants Who Underwent Surgical or Interventional Radiological Procedures to Stop Bleeding Related to the Primary Injury | 78.0 | 75.5 |
The number of participants with treatment-emergent SAEs considered related to IP that occurred during primary hospitalization within the 30 days after randomization are summarized by treatment arm.
| Count of participants | BE1116 | Placebo |
|---|---|---|
| Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs) | 34 | 46 |
The TEEs may be symptomatic or asymptomatic, and arterial or venous (eg, deep vein thrombosis, pulmonary embolism, ischemic stroke \[including thromboembolic stroke\], myocardial infarction). The observed in-hospital overall and related to IP TEEs are reported here.
| Count of participants | BE1116 | Placebo |
|---|---|---|
| Overall TEEs | 133 | 139 |
| Related TEEs | 46 | 51 |
ARDS will be assessed using the Berlin definition based on four criteria: timing, chest imaging, origin of edema, oxygenation (mild, moderate or severe) and high-flow nasal oxygen.
| Count of participants | BE1116 | Placebo |
|---|---|---|
| Number of Participants With Acute Respiratory Distress Syndrome (ARDS) | 31 | 28 |
Multiple organ failure will be assessed using the Denver post injury multiple organ failure score. The Denver score rates the dysfunction of 4 organ systems (pulmonary, renal, hepatic, and cardiac), which are each graded on a scale from 0 to 3, where 0 represents "mild" and 3 was "severe". Multiple organ failure is defined as a score \> 3.
| Count of participants | BE1116 | Placebo |
|---|---|---|
| Number of Participants With Multiple Organ Failure | 59 | 53 |
Renal replacement therapy included dialysis, hemofiltration, or hemodiafiltration. AKI according to the Kidney Disease Improving Global Outcomes (KDIGO) guidelines is diagnosed if any one of the following happens: • Serum creatinine increases by ≥ 0.3 mg/dL (≥ 26.5 μmol/L) within 48 hours • Serum creatinine increases to ≥ 1.5 times the baseline level, within the past 7 days • Urine levels drops to less than 0.5 mL/kg/hour for 6 hours
| Count of participants | BE1116 | Placebo |
|---|---|---|
| Number of Participants With Acute Kidney Injury (AKI) Requiring Renal Replacement Therapy | 52 | 29 |
Collected over Up to 30 days after randomization. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BE1116 | 146/689 (21.2%) | 203/618 (32.8%) | 32/618 (5.2%) |
| Placebo | 114/677 (16.8%) | 168/627 (26.8%) | 39/627 (6.2%) |
| Event | BE1116 | Placebo |
|---|---|---|
| Acute kidney injuryRenal and urinary disorders | 50/618 | 24/627 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 42/618 | 48/627 |
| Multiple organ dysfunction syndromeGeneral disorders | 43/618 | 36/627 |
| Deep vein thrombosisVascular disorders | 30/618 | 21/627 |
| PneumoniaInfections and infestations | 25/618 | 27/627 |
| Acute respiratory distress syndromeRespiratory, thoracic and mediastinal disorders | 18/618 | 21/627 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 10/618 | 5/627 |
| Septic shockInfections and infestations | 8/618 | 8/627 |
| Cardiac arrestCardiac disorders | 8/618 | 7/627 |
| Acute Respiratory failureRespiratory, thoracic and mediastinal disorders | 7/618 | 4/627 |
| Event | BE1116 | Placebo |
|---|---|---|
| Deep vein thrombosisVascular disorders | 32/618 | 39/627 |
Analysis was performed on Intent-to-treat (ITT) population, which included all randomized participants. In this population, analyses were based on the treatment to which participants were randomized, regardless of any treatment they received.
| Age, Continuous(years) | BE1116 | Placebo | Total |
|---|---|---|---|
| Mean | 40.7 ± 17.00 | 39.8 ± 17.65 | 40.2 ± 17.33 |
| Sex: Female, Male(Participants) | BE1116 | Placebo | Total |
|---|---|---|---|
| Female | 163 | 141 | 304 |
| Male | 526 | 536 | 1062 |
| Ethnicity (NIH/OMB)(Participants) | BE1116 | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 97 | 87 | 184 |
| Not Hispanic or Latino | 490 | 493 | 983 |
| Unknown or Not Reported | 102 | 97 | 199 |
| Race (NIH/OMB)(Participants) | BE1116 | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 9 | 12 | 21 |
| Asian | 13 | 21 | 34 |
| Native Hawaiian or Other Pacific Islander | 3 | 1 | 4 |
| Black or African American | 201 | 210 | 411 |
| White | 350 | 335 | 685 |
| More than one race | 5 | 5 | 10 |
| Unknown or Not Reported | 108 | 93 | 201 |
Showing the first 100 of 113 sites across 3 countries.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.
Supporting information: Study protocol, Sap
This study is terminated, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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