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NCT07094087 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of 4F-PCC (4-Factor Prothrombin Complex Concentrate) in Adult Patients Undergoing Complex Cardiovascular Surgery With Cardiopulmonary Bypass (CPB)
A Phase 3 study of Complex Cardiovascular Surgery With Cardiopulmonary Bypass, sponsored by CSL Behring.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 200
- Enrollment target
- 19
- Study locations
NCT07094087 is a Phase 3 study of Complex Cardiovascular Surgery With Cardiopulmonary Bypass that is actively recruiting participants, run by CSL Behring. The registered enrollment target is 200 participants. The trial reports 19 study locations across 17 states.
The verdict
NCT07094087, a Phase 3 study of Complex Cardiovascular Surgery With Cardiopulmonary Bypass, is actively recruiting participants, sponsored by CSL Behring.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 200 participants
- Enrollment target
- 19
- Study locations
Study Summary
This is a phase 3, multicenter, randomized, open-label, parallel-group, controlled study to assess the efficacy and safety of BE1116 compared with fresh frozen plasma (FFP) in adult participants undergoing complex cardiovascular surgery with CPB. The primary purpose of the study is to compare the efficacy of BE1116 and FFP in correcting coagulation factor deficiencies in bleeding participants undergoing complex cardiovascular surgery with CPB.
Conditions Studied
Interventions
- BIOLOGICAL BE1116
- BIOLOGICAL FFP
Study Locations (19)
Ontario
- Kingston Health Science Center - Kingston
- London Health Sciences Center - University Campus - London
- University of Toronto - St. Michael's Hospital (SMH) - Keenan Research Centre for Biomedical Science - Toronto
California
- UCLA Health - Ronald Reagan Medical Center - Los Angeles
Illinois
- University of Chicago Medicine - Chicago
Maryland
- University of Maryland Medical Center (UMMC) - Baltimore
New York
- North Shore University Hospital - Manhasset
Ohio
- University of Cincinnati - Cincinnati
Oklahoma
- OUHSC (University of Oklahoma Health Sciences Center) - Oklahoma City
Oregon
- Oregon Health & Sciences University - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2025-09-15 |
| Est. Completion | 2026-12-17 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07094087
The ClinicalTrials.gov registry entry for NCT07094087 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 200 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 1 condition, with Complex Cardiovascular Surgery With Cardiopulmonary Bypass appearing as the primary indexed condition, and to 2 interventions - of which BE1116 is the first listed.
NCT07094087 reports 19 study locations spanning 17 distinct geographic areas - top geographies include Ontario, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT07094087 about?
NCT07094087 is a clinical study titled "Efficacy and Safety of 4F-PCC (4-Factor Prothrombin Complex Concentrate) in Adult Patients Undergoing Complex Cardiovascular Surgery With Cardiopulmonary Bypass (CPB)". This is a phase 3, multicenter, randomized, open-label, parallel-group, controlled study to assess the efficacy and safety of BE1116 compared with fresh frozen plasma (FFP) in adult participants undergoing complex cardiovascular surgery with CPB. The primary purpose of the study is to compare the ef...
What is the current status of trial NCT07094087?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 200 participants. The study started on 2025-09-15. Estimated completion is 2026-12-17.
What conditions does trial NCT07094087 study?
This clinical trial studies the following conditions: Complex Cardiovascular Surgery With Cardiopulmonary Bypass.
What interventions are being tested in trial NCT07094087?
The interventions under investigation include: BE1116 (BIOLOGICAL), FFP (BIOLOGICAL).
Who is sponsoring clinical trial NCT07094087?
This trial is sponsored by CSL Behring, which has 71 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07094087 being conducted?
This trial has 19 study locations across California, Illinois, Maryland, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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