Efficacy and Safety of 4F-PCC (4-Factor Prothrombin Complex Concentrate) in Adult Patients Undergoing Complex Cardiovascular Surgery With Cardiopulmonary Bypass (CPB)

Phase 3 Recruiting 200 enrolled CSL Behring

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2025-09-15
Primary completion: 2026-11-18
Completion: 2026-12-17

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BE1116	Protein / enzyme biologic	—	Intravenous
Comparator	Fresh Frozen Plasma	Protein / enzyme biologic	—	Intravenous

Indications

No indication recorded.