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

Conditions

• Complex Cardiovascular Surgery With Cardiopulmonary Bypass

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Sep 15, 2025

Status verified

May 2026

Primary completion

Nov 18, 2026

Completion

Dec 17, 2026

Study Design

Enrollment

200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: BE1116
• Active Comparator: Fresh frozen plasma

Primary Outcome Measure

Number of Participants With and Without a Successful Correction of Coagulation Factor Deficiency [ Time Frame: At Day 1 after IP infusion (30 minutes after the end of infusion) ]

Central Contacts

• Trial Registration Coordinator
  +1 610-878-4697
  [email protected]

Locations (10)

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