Traumatic InjuryPhase 3NCT05568888

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

A Phase 3 study testing BE1116 in people with Traumatic Injury, run by CSL Behring at 113 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial 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… Read more about this study

Who is it for?: Ages 15 years and older
Conditions the study is for: Traumatic Injury
What is being tested?: BE1116
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,366 participants
Where: 113 sitesin 3 countries
Study dates: 28 Mar 2023to 29 Oct 2024
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 15 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

(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

Who cannot join

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.

Trial locations and contacts

113 sites in 3 countries.

Country

City, postcode or hospital

113 sites in 3 countries

United States90 sites

Summa Health System - Akron Campus
Akron, Ohio, 44304
University Hospital
Ann Arbor, Michigan, 48109
Grady Memorial Hospital
Atlanta, Georgia, 30303
Augusta University Medical Center
Augusta, Georgia, 30912
University of Colorado Aurora
Aurora, Colorado, 80045
Dell Seton Medical Center
Austin, Texas, 78701
UAB Hospital
Birmingham, Alabama, 35233
Tufts Medical Center
Boston, Massachusetts, 02111
Erie County Medical Center
Buffalo, New York, 14215
Cooper Health Care
Camden, New Jersey, 08103
Chandler Regional Medical Center
Chandler, Arizona, 85224
Carolinas Medical Center
Charlotte, North Carolina, 28203
Erlanger Baroness Hospital
Chattanooga, Tennessee, 37403
University of Chicago Medical Center
Chicago, Illinois, 60637
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
MetroHealth Medical Center
Cleveland, Ohio, 44109
UC Health Memorial Hospital Central
Colorado Springs, Colorado, 80909
The Ohio State University
Columbus, Ohio, 43210
Denver Health and Hospital Authority
Denver, Colorado, 80204
Henry Ford Hospital
Detroit, Michigan, 48202
Duke University
Durham, North Carolina, 27710
University Medical Center El Paso
El Paso, Texas, 79905
Sanford Medical Center Fargo
Fargo, North Dakota, 58104
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
JPS Health Network (John Peter Smith Hospital)
Fort Worth, Texas, 76134
Northeast Georgia Health System
Gainesville, Georgia, 30501
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Ben Taub General Hospital - Baylor Medical Center - Harris Health Network
Houston, Texas, 77030
Memorial Hermann Hospital
Houston, Texas, 77030
Indiana University Methodist Hospital
Indianapolis, Indiana, 46202
St. Vincent's Hospital
Indianapolis, Indiana, 46260
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
University of Mississippi Medical Center (UMMC)
Jackson, Mississippi, 39216
UF Health Jacksonville
Jacksonville, Florida, 32209
Kansas University Medical Center
Kansas City, Kansas, 66160
University of Tennessee Medical Center - UTMCK
Knoxville, Tennessee, 37920
University of Kentucky Albert B. Chandler Hospital
Lexington, Kentucky, 40536
UAMS Medical Center
Little Rock, Arkansas, 72205
LAC+USC Medical Center
Los Angeles, California, 90033
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
University of Louisville Hospital
Louisville, Kentucky, 40202
Medical Center of the Rockies
Loveland, Colorado, 80538
Atrium Health - Medical Center of central Georgia
Macon, Georgia, 31201
University Hospital
Madison, Wisconsin, 53792
Regional Medical Center
Memphis, Tennessee, 38103
University of Miami/Ryder Trauma Center
Miami, Florida, 33136
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, 53226
NYU Langone
Mineola, New York, 11501
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
University of South Alabama
Mobile, Alabama, 36507
Riverside University Health System Medical Center
Moreno Valley, California, 92555
J.W. Ruby Memorial Hospital
Morgantown, West Virginia, 26505
Intermountain Medical Center
Murray, Utah, 84107
Vanderbilt Hospital and Clinics
Nashville, Tennessee, 37027
Yale New Haven Hospital
New Haven, Connecticut, 06510
University Medical Center of New Orleans
New Orleans, Louisiana, 70112
Rutgers New Jersey Medical School
Newark, New Jersey, 07103
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma, 73104
UNMC (University of Nebraska Medical Center)
Omaha, Nebraska, 68198
UC Irvine
Orange, California, 92868
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Banner - University Medical Center Phoenix
Phoenix, Arizona, 85006
Valleywise Medical Center
Phoenix, Arizona, 85008
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
University of Pittsburgh Medical Center Presbyterian
Pittsburgh, Pennsylvania, 15213
Oregon Health and Sciences University Hospital
Portland, Oregon, 97239
Brown University (Rhode Island Hospital)
Providence, Rhode Island, 02903
Jamaica Hospital Medical Center
Richmond Hill, New York, 11418
North Memorial Hospital
Robbinsdale, Minnesota, 55422
UC Davis Medical Center
Sacramento, California, 95817
Health Partners Regions Hospital
Saint Paul, Minnesota, 55101
University of Utah Hospital
Salt Lake City, Utah, 84132
University Hospital
San Antonio, Texas, 78229
UC San Diego Medical Center
San Diego, California, 92103
San Francisco General Hospital and Trauma Center
San Francisco, California, 94110
HonorHealth Scottsdale Osborn Medical Center
Scottsdale, Arizona, 85251
Harborview Medical Center
Seattle, Washington, 98104
LSU Health Shreveport
Shreveport, Louisiana, 71103
Sanford USD Medical Center
Sioux Falls, South Dakota, 57117
SSM Health St. Louis
St Louis, Missouri, 63104
Barnes Jewish Hospital
St Louis, Missouri, 63110
Mercy Health - St. Vincent Medical Center
Toledo, Ohio, 43608
Capital Health Regional Medical Center
Trenton, New Jersey, 08638
University Medical Center Tucson
Tucson, Arizona, 85719
UT Health Tyler
Tyler, Texas, 75701
MedStar Washington Medical Center
Washington D.C., District of Columbia, 20010
George Washington University Hospital
Washington D.C., District of Columbia, 20037
Reading Hospital
West Reading, Pennsylvania, 19611
Wake Forest Medical Center
Winston-Salem, North Carolina, 27157

Other trials in United States

United Kingdom14 sites

Queen Elizabeth Hospital
Birmingham, B15 2GW
Southmead Hospital
Bristol, BS10 5NB
Cambridge Addenbrookes University
Cambridge, CB2 0QQ
University Hospital Coventry
Coventry, CV2 2DX
Hull Royal Infirmary Hull University Teaching Hospitals NHS Trust
Hull, HU3 2JZ
Leeds Teaching Hospital
Leeds, LS1 3EX
Aintree University Hospital
Liverpool, L9 7AL
St. Georges Hospital
London, SW17 0QT
Imperial College Healthcare
London, SW7 1LY
Royal Victoria Infirmary
Newcastle upon Tyne, NE14LP
Queen's Medical Centre, Nottingham University Hospitals NHS Trust
Nottingham, NG7 2UH
John Radcliffe Hospital
Oxford, OX3 9DU
Sheffield Teaching Hospital
Sheffield, S10 2JF
Royal Stoke University Hospital
Stoke-on-Trent, ST4 6QG

Other trials in United Kingdom

Australia9 sites

Royal Adelaide
Adelaide, South Australia, 5000
Royal Hobart Hospital
Hobart, Tasmania, 7000
St. George Hospital
Kogarah, Sydney
Alfred Hospital
Melbourne, Victoria, 3004
Royal Perth Hospital
Perth, Western Australia, 6000
Liverpool Hospital
Sydney, Liverpool, NSW 2170
John Hunter Hospital
Sydney, New Lambton, 2305
Royal Prince Alfred Hospital
Sydney, New South Wales
Westmead Hospital
Westmead, Sydney, 2145

Other trials in Australia

About this study

Official title: 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

Conditions: Traumatic Injury
Being tested: BE1116, Placebo
Medical subject headings: Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BE1116Drug
Also called 4-Factor Prothrombin Complex, Kcentra®, Beriplex®
4-Factor Prothrombin Complex administered by intravenous (IV) infusion
PlaceboDrug
Administered by IV infusion

Study groups in NCT05568888
Study group	Role	What they receive
BE1116	Experimental	Administration by IV infusion Receives: Drug: BE1116
Placebo	Placebo comparator	Administration by IV infusion Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to 6 hours after randomization

Secondary outcomes (8)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Up to 30 days after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Mar 202329 Oct 2024

First posted6 Oct 2022
Study start28 Mar 2023
Primary completion29 Oct 2024
Study completion29 Oct 2024

Why it 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.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Traumatic InjuryStudies of the same condition, open and under way.
More trials run by CSL BehringThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,366 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05568888
Sponsor's protocol ID: BE1116_3006
Other IDs: 2021-005060-21
Status last verified: Nov 2025
First submitted: 3 Oct 2022
Last updated: 10 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Traumatic Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT05568888
Acronym / sponsor ID: BE1116_3006
Conditions: Traumatic Injury
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason 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.
Enrolment: 1,366 participants (actual)
Lead sponsor: CSL BehringIndustry (pharma, biotech, devices)
Study start: 28 Mar 2023 (actual)
Primary completion: 29 Oct 2024 (actual)
Study completion: 29 Oct 2024 (actual)
First posted: 6 Oct 2022 (actual)
Results: Posted 10 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
BE1116	Experimental	Drug: BE1116Administration by IV infusion
Placebo	Placebo comparator	Drug: PlaceboAdministration by IV infusion

Who may qualify

Ages: 15 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

(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

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BE1116Also: 4-Factor Prothrombin Complex, Kcentra®, Beriplex®4-Factor Prothrombin Complex administered by intravenous (IV) infusion	Drug	BE1116
PlaceboAdministered by IV infusion	Drug	Placebo

Primary outcome

Proportion of Participants With All-cause 6-hour Mortality
Time frame: Up to 6 hours after randomization
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.

8 secondary outcomes

Proportion of Participants With All-cause 24-hour In-hospital Mortality
Time frame: Up to 24 hours after randomization
Proportion of Participants With All-cause In-hospital Mortality Up to 30 Days After Randomization
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
Time frame: Up to 24 hours after randomization
Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs)
Time frame: Up to 30 days after randomization
Number of Participants With In-hospital Overall and Related Thromboembolic Events (TEEs)
Time frame: Up to 30 days after randomization
Number of Participants With Acute Respiratory Distress Syndrome (ARDS)
Time frame: Up to 30 days after randomization
Number of Participants With Multiple Organ Failure
Time frame: Up to 30 days after randomization
Number of Participants With Acute Kidney Injury (AKI) Requiring Renal Replacement Therapy
Time frame: Up to 30 days after randomization

Results and safety

Results posted to the registry on 10 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BE1116	689	628
Placebo	677	605

Primary outcome: Proportion of Participants With All-cause 6-hour Mortality

Time frame: Up to 6 hours after randomization. Number. Unit: Percentage of participants

Measure	BE1116 n = 689	Placebo n = 677
All-cause Mortality in ITT Analysis Set	7.3	4.6
All-cause Mortality in mITT Analysis Set	7.2	4.1

BE1116 vs Placebo: Estimated difference Placebo - BE1116: -2.5 (95% CI -5.02 to -0.13), p = 1.9, Regression, Logistic
BE1116 vs Placebo: Estimated difference Placebo - BE1116: -2.8 (95% CI -5.80 to 0.13), p = 3.1, Regression, Logistic

Population analysed: Analysis was performed on the ITT and modified ITT (mITT) population. The ITT population included all the randomized participants. The mITT population included all participants from ITT population who received at least one complete or partial dose of the investigational product (IP) (BE1116 or placebo). It also included participants with a missing or non-testable Glasgow Coma Score, or a score less than 15, as well as those who received blood product transfusions prior to randomization.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 30 days after randomization. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BE1116	203 of 618 (32.8%)	32 of 618 (5.2%)	146 of 689
Placebo	168 of 627 (26.8%)	39 of 627 (6.2%)	114 of 677

Limitations and caveats (from the sponsor): The study was terminated due to feasibility reasons. No safety issues contributed to the decision to terminate the study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: 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.

Related trials for Traumatic Injury

Recruiting
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Study Director study director

CSL Behring

113 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BE1116 in people with Traumatic Injury, run by CSL Behring at 113 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 113 sites in United States, United Kingdom, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Participants With All-cause 6-hour Mortality (time frame: Up to 6 hours after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05568888.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.