NCT07094087

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, Multicenter, Randomized, Open-label, Controlled Study to Investigate the Efficacy and Safety of 4-Factor Prothrombin Complex Concentrate in Adult Patients Undergoing Complex Cardiovascular Surgery With Cardiopulmonary Bypass

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: CSL Behring · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Complex Cardiovascular Surgery With Cardiopulmonary Bypass

Interventions

Type	Name	Description
BIOLOGICAL	BE1116	A single dose of BE1116 will be administered by intravenous (IV) infusion intraoperatively.
BIOLOGICAL	FFP	A single dose of FFP will be administered as investigational product (IP) by IV infusion intraoperatively.

Timeline

• Start date: 2025-09-15
• Primary completion: 2026-11-18
• Completion: 2026-12-17
• First posted: 2025-07-30
• Last updated: 2026-04-16

Locations

19 sites across 4 countries: United States, Canada, Japan, Mexico

Regulatory

• FDA-regulated drug study