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NCT05568888 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by CSL Behring.

Terminated
Registry status
Phase 3
Development phase
1,366
Enrollment target

NCT05568888 is a Phase 3 study that was terminated before completion, run by CSL Behring. The registered enrollment target is 1,366 participants.

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The verdict

NCT05568888, a Phase 3 study, was terminated before completion, sponsored by CSL Behring.

TERMINATED
Registry status
Phase 3
Development phase
1,366 participants
Enrollment target

Study 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.

Interventions

  • DRUG Placebo
  • DRUG BE1116

Trial Details

FieldValue
Enrollment Target 1,366 participants
Start Date 2023-03-28
Est. Completion 2024-10-29
Phase Phase 3

Sponsor

CSL Behring

71 total trials

What the Registry Record Tells You About NCT05568888

The ClinicalTrials.gov registry entry for NCT05568888 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 1,366 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CSL Behring, which has 71 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT05568888 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT05568888 about?

NCT05568888 is a clinical study titled "Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival ( TAP Study )". 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...

What is the current status of trial NCT05568888?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1,366 participants. The study started on 2023-03-28. Estimated completion is 2024-10-29.

What interventions are being tested in trial NCT05568888?

The interventions under investigation include: Placebo (DRUG), BE1116 (DRUG).

Who is sponsoring clinical trial NCT05568888?

This trial is sponsored by CSL Behring, which has 71 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.