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

NCT05568888 | Terminated Phase 3 Results DMC FDA Drug

• 2 other identifiers: BE1116_30062021-005060-21
• Study Type: interventional
• Target: 1,366
• Locations: 3 countries
• Sites: 113

Brief 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

Traumatic Injury

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 6 hours after randomization

Secondary Outcomes (8)

• Proportion of Participants With All-cause 24-hour In-hospital Mortality

  Up to 24 hours after randomization

• Proportion of Participants With All-cause In-hospital Mortality Up to 30 Days After Randomization

  Up to 30 days after randomization

• Proportion of Participants Who Underwent Surgical or Interventional Radiological Procedures to Stop Bleeding Related to the Primary Injury

  Up to 24 hours after randomization

• Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs)

  Up to 30 days after randomization

• Number of Participants With In-hospital Overall and Related Thromboembolic Events (TEEs)

  Up to 30 days after randomization

Study Arms (2)

BE1116

EXPERIMENTAL

Administration by IV infusion

Drug: BE1116

Placebo

PLACEBO COMPARATOR

Administration by IV infusion

Drug: Placebo

Interventions

Placebo DRUG

Administered by IV infusion

Placebo

BE1116 DRUG

4-Factor Prothrombin Complex administered by intravenous (IV) infusion

Also known as: 4-Factor Prothrombin Complex, Kcentra®, Beriplex®

BE1116

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• (a) Estimated age ≥ 15 years. Older minimum age is required in some locations. FOR United Kingdom: Estimated or actual age ≥ 16 years FOR Australia: Estimated or actual age ≥ 18 years AND (b) Estimated or actual weight ≥ 50 kg (110 lbs).
• Traumatic injury with confirmed or suspected acute major bleeding and/or Revised Assessment of Bleeding and Transfusion (RABT) score ≥ 2
• Activation of massive transfusion protocol

You may not qualify if:

• Healthcare professional cardiopulmonary resuscitation including chest compressions for ≥ 5 consecutive minutes at any time before randomization
• Isolated penetrating or blunt cranial injury, or exposed brain matter
• Isolated burns estimated to be \> 20% total body surface area or suspected inhalational injury
• Known anticoagulation treatment or a history of a TEE, within the past 3 months.

Sponsors & Collaborators

• CSL Behring: lead

Study Sites (113)

UAB Hospital

Birmingham, Alabama, 35233, United States

Location

University of South Alabama

Mobile, Alabama, 36507, United States

Location

Chandler Regional Medical Center

Chandler, Arizona, 85224, United States

Location

Banner - University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

Location

Valleywise Medical Center

Phoenix, Arizona, 85008, United States

Location

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

Location

HonorHealth Scottsdale Osborn Medical Center

Scottsdale, Arizona, 85251, United States

Location

University Medical Center Tucson

Tucson, Arizona, 85719, United States

Location

UAMS Medical Center

Little Rock, Arkansas, 72205, United States

Location

LAC+USC Medical Center

Los Angeles, California, 90033, United States

Location

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

Location

Riverside University Health System Medical Center

Moreno Valley, California, 92555, United States

Location

UC Irvine

Orange, California, 92868, United States

Location

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

UC San Diego Medical Center

San Diego, California, 92103, United States

Location

San Francisco General Hospital and Trauma Center

San Francisco, California, 94110, United States

Location

University of Colorado Aurora

Aurora, Colorado, 80045, United States

Location

UC Health Memorial Hospital Central

Colorado Springs, Colorado, 80909, United States

Location

Denver Health and Hospital Authority

Denver, Colorado, 80204, United States

Location

Medical Center of the Rockies

Loveland, Colorado, 80538, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

MedStar Washington Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

George Washington University Hospital

Washington D.C., District of Columbia, 20037, United States

Location

UF Health Jacksonville

Jacksonville, Florida, 32209, United States

Location

University of Miami/Ryder Trauma Center

Miami, Florida, 33136, United States

Location

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Augusta University Medical Center

Augusta, Georgia, 30912, United States

Location

Northeast Georgia Health System

Gainesville, Georgia, 30501, United States

Location

Atrium Health - Medical Center of central Georgia

Macon, Georgia, 31201, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Indiana University Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

St. Vincent's Hospital

Indianapolis, Indiana, 46260, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Kansas University Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Kentucky Albert B. Chandler Hospital

Lexington, Kentucky, 40536, United States

Location

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

Location

University Medical Center of New Orleans

New Orleans, Louisiana, 70112, United States

Location

LSU Health Shreveport

Shreveport, Louisiana, 71103, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

University Hospital

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

North Memorial Hospital

Robbinsdale, Minnesota, 55422, United States

Location

Health Partners Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

University of Mississippi Medical Center (UMMC)

Jackson, Mississippi, 39216, United States

Location

SSM Health St. Louis

St Louis, Missouri, 63104, United States

Location

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

UNMC (University of Nebraska Medical Center)

Omaha, Nebraska, 68198, United States

Location

Cooper Health Care

Camden, New Jersey, 08103, United States

Location

Rutgers New Jersey Medical School

Newark, New Jersey, 07103, United States

Location

Capital Health Regional Medical Center

Trenton, New Jersey, 08638, United States

Location

Erie County Medical Center

Buffalo, New York, 14215, United States

Location

NYU Langone

Mineola, New York, 11501, United States

Location

Jamaica Hospital Medical Center

Richmond Hill, New York, 11418, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Wake Forest Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Sanford Medical Center Fargo

Fargo, North Dakota, 58104, United States

Location

Summa Health System - Akron Campus

Akron, Ohio, 44304, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Mercy Health - St. Vincent Medical Center

Toledo, Ohio, 43608, United States

Location

University of Oklahoma Health Science Center

Oklahoma City, Oklahoma, 73104, United States

Location

Oregon Health and Sciences University Hospital

Portland, Oregon, 97239, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

University of Pittsburgh Medical Center Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

Location

Reading Hospital

West Reading, Pennsylvania, 19611, United States

Location

Brown University (Rhode Island Hospital)

Providence, Rhode Island, 02903, United States

Location

Sanford USD Medical Center

Sioux Falls, South Dakota, 57117, United States

Location

Erlanger Baroness Hospital

Chattanooga, Tennessee, 37403, United States

Location

University of Tennessee Medical Center - UTMCK

Knoxville, Tennessee, 37920, United States

Location

Regional Medical Center

Memphis, Tennessee, 38103, United States

Location

Vanderbilt Hospital and Clinics

Nashville, Tennessee, 37027, United States

Location

Dell Seton Medical Center

Austin, Texas, 78701, United States

Location

University Medical Center El Paso

El Paso, Texas, 79905, United States

Location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

JPS Health Network (John Peter Smith Hospital)

Fort Worth, Texas, 76134, United States

Location

Ben Taub General Hospital - Baylor Medical Center - Harris Health Network

Houston, Texas, 77030, United States

Location

Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

University Hospital

San Antonio, Texas, 78229, United States

Location

UT Health Tyler

Tyler, Texas, 75701, United States

Location

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

University of Utah Hospital

Salt Lake City, Utah, 84132, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

J.W. Ruby Memorial Hospital

Morgantown, West Virginia, 26505, United States

Location

University Hospital

Madison, Wisconsin, 53792, United States

Location

Froedtert Memorial Lutheran Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Liverpool Hospital

Sydney, Liverpool, NSW 2170, Australia

Location

John Hunter Hospital

Sydney, New Lambton, 2305, Australia

Location

Royal Prince Alfred Hospital

Sydney, New South Wales, Australia

Location

Royal Adelaide

Adelaide, South Australia, 5000, Australia

Location

St. George Hospital

Kogarah, Sydney, Australia

Location

Westmead Hospital

Westmead, Sydney, 2145, Australia

Location

Royal Hobart Hospital

Hobart, Tasmania, 7000, Australia

Location

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Location

Queen Elizabeth Hospital

Birmingham, B15 2GW, United Kingdom

Location

Southmead Hospital

Bristol, BS10 5NB, United Kingdom

Location

Cambridge Addenbrookes University

Cambridge, CB2 0QQ, United Kingdom

Location

University Hospital Coventry

Coventry, CV2 2DX, United Kingdom

Location

Hull Royal Infirmary Hull University Teaching Hospitals NHS Trust

Hull, HU3 2JZ, United Kingdom

Location

Leeds Teaching Hospital

Leeds, LS1 3EX, United Kingdom

Location

Aintree University Hospital

Liverpool, L9 7AL, United Kingdom

Location

St. Georges Hospital

London, SW17 0QT, United Kingdom

Location

Imperial College Healthcare

London, SW7 1LY, United Kingdom

Location

Royal Victoria Infirmary

Newcastle upon Tyne, NE14LP, United Kingdom

Location

Queen's Medical Centre, Nottingham University Hospitals NHS Trust

Nottingham, NG7 2UH, United Kingdom

Location

John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

Location

Sheffield Teaching Hospital

Sheffield, S10 2JF, United Kingdom

Location

Royal Stoke University Hospital

Stoke-on-Trent, ST4 6QG, United Kingdom

Location

MeSH Terms

Conditions

Wounds and Injuries

Interventions

factor IX, factor VII, factor X, prothrombin drug combination

Limitations and Caveats

The study was terminated due to feasibility reasons. No safety issues contributed to the decision to terminate the study.

Results Point of Contact

• Title: Study Director
• Organization: CSL Behring

clinicaltrials@cslbehring.com

16108784000

Study Officials

• Study Director

  CSL Behring

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 6, 2022
• Study Start: March 28, 2023
• Primary Completion: October 29, 2024
• Study Completion: October 29, 2024
• Last Updated: December 10, 2025
• Results First Posted: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Requests for IPD will generally be considered once review by major regulatory authorities (ie FDA, EMA) is complete and the primary publication is available.
• Access Criteria: Proposed research should seek to answer a previously unanswered important medical or scientific question. Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD. If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.

Locations

GB (14); US (90); AU (9)