BE1116 for Open-heart Surgery

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: CSL Behring

Must not be taking: Cryoprecipitate, Platelets, FEIBA, others

Disqualifiers: Heart transplant, Ventricular assist devices, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called BE1116 for individuals undergoing complex heart surgeries. It aims to determine if BE1116 is more effective than the usual treatment, fresh frozen plasma, in aiding blood clotting during surgery. The trial seeks adults scheduled for specific planned heart surgeries involving a heart-lung machine who experience significant bleeding not caused by surgical complications. Those meeting these criteria and interested in exploring a new treatment option might find this trial suitable. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot have received certain blood-related treatments like cryoprecipitate or platelets in the 24 hours before the surgery.

Is there any evidence suggesting that BE1116 is likely to be safe for humans?

An earlier study tested BE1116 on patients with serious injuries and heavy bleeding. The results showed no safety problems, suggesting that BE1116 is generally safe. Although this study didn't focus on heart surgery, it still provides helpful safety information. Since the current trial is in phase 3, BE1116 has already passed earlier safety tests. This phase aims to confirm its safety and effectiveness in a larger group of people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

BE1116 is unique because it offers a novel approach to managing bleeding during open-heart surgery. Unlike the standard use of fresh frozen plasma, which requires careful matching and thawing, BE1116 is a synthetic option that can be administered more quickly and easily. Researchers are excited about BE1116 because it has the potential to reduce bleeding more effectively and safely, thanks to its targeted mechanism of action that enhances clot formation without relying on donor blood products. This could lead to faster recovery times and fewer complications for patients undergoing surgery.

What evidence suggests that BE1116 might be an effective treatment for coagulation factor deficiencies in complex cardiovascular surgery?

Research has shown that BE1116, a type of medication, is effective for patients undergoing major heart surgeries. In this trial, participants will receive either BE1116 or fresh frozen plasma (FFP) as part of their treatment. Studies indicate that BE1116 outperforms FFP in aiding blood clotting, which is crucial during complex heart surgeries with a risk of bleeding. BE1116 quickly addresses issues with clotting factors, the proteins necessary for proper blood clotting. These findings suggest that BE1116 could be a promising option for managing bleeding during open-heart surgery. ^{2 3 5 6 7}

Who Is on the Research Team?

Study Director

Principal Investigator

CSL Behring

Are You a Good Fit for This Trial?

Adults undergoing complex cardiovascular surgery with cardiopulmonary bypass (CPB) can join this trial. They should need treatment for coagulation factor deficiencies due to bleeding during surgery. People who have conditions that might interfere with the study or pose additional risks are not eligible.

Inclusion Criteria

* Adult greater than or equal to (\>=) 18 years and has provided written informed consent.

* Undergoing elective complex cardiovascular surgery requiring CPB, including procedures of the thoracic aorta (with or without additional cardiac interventions), aortic valve replacement + coronary artery bypass graft (CABG), complex valve surgeries, mitral valve repair + CABG, and mitral valve replacement + CABG and reoperative CABG. Reoperative procedures are permitted. Excluded surgeries are as follows: heart transplantation, insertion or removal of ventricular assist devices (except for intra-aortic balloon pumps), and acute repair of thoracoabdominal aneurysms.

* INR \>= 1.6 (point-of-care INR testing by Hemochron at least 10 minutes after protamine infusion for heparin reversal). If a participant needs a second dose of protamine, a new INR measurement should be performed to confirm eligibility.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BE1116 or fresh frozen plasma during complex cardiovascular surgery with CPB

1 day

Intraoperative visit

Immediate Postoperative Monitoring

Participants are monitored for hemostatic response and coagulation factor correction

24 hours

Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• BE1116

Trial Overview

The trial is testing BE1116 against fresh frozen plasma (FFP) to see which one is better at correcting blood clotting problems in patients bleeding during open-heart surgery. Participants will be randomly assigned to receive either BE1116 or FFP in an open-label, controlled setup.

How Is the Trial Designed?

Group I: BE1116 Experimental Treatment 1 Intervention

Group II: Fresh frozen plasma Active Control 1 Intervention

Who Is Running the Clinical Trial?

CSL Behring

Lead Sponsor

Trials

204

Recruited

1,207,000+

Dr. Paul McKenzie

CSL Behring

Chief Executive Officer since 2023

PhD in Chemical Engineering from Carnegie Mellon University, B.S. in Chemical Engineering from the University of Pennsylvania

Dr. Bill Mezzanotte

CSL Behring

Chief Medical Officer since 2021

MD from Duke University

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07094087

NCT07094087 | Efficacy and Safety of 4F-PCC (4-Factor ...

The primary purpose of the study is to compare the efficacy of BE1116 and FFP in correcting coagulation factor deficiencies in bleeding participants undergoing ...

2.

withpower.com

withpower.com/trial/phase-3-complex-cardiovascular-surgery-with-cardiopulmonary-bypass-8-2025-3a759

BE1116 for Open-heart Surgery · Info for Participants

The primary purpose of the study is to compare the efficacy of BE1116 and FFP in correcting coagulation factor deficiencies in bleeding participants undergoing ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41089581/

Effectiveness of Prothrombin Complex Concentrate Versus ...

In patients undergoing major cardiac surgeries, the use of PCC showed superior effectiveness over FFP regarding hemostatic efficacy and other ...

4.

alfredhealth.org.au

alfredhealth.org.au/research/clinical-trials/find-clinical-trials/a-prospective-multicentre-randomized-double-blind-placebo-controlled-large-simple-trial-evaluating-the-use-of-be1116-4-factor-prothrombin-complex-concentrate-kcentra-beriplex-to-imp

A Prospective, Multicentre, Randomized, Double-Blind ...

A Prospective, Multicentre, Randomized, Double-Blind, Placebo-Controlled, Large Simple Trial Evaluating the Use of BE1116 (4-Factor Prothrombin Complex ...

5.

medstarhealth.org

medstarhealth.org/innovation-and-research/medstar-health-research-institute/clinical-trials

Clinical Trials | Research Study

A prospective, multicenter, randomized, controlled clinical trial, to evaluate the safety and effectiveness of the TricValve® Transcatheter Bicaval Valve ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05568888

Study Details | NCT05568888 | Evaluation of BE1116 in ...

No safety issues were found. Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival ( TAP Study ). ClinicalTrials.

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40676729/

Assessing the Safety, Feasibility, and Clinical Outcomes of ...

In total, 94.6% (n = 2649) of patients were discharged the day after surgery. Of those requiring ICU care (n = 152), circulatory failure (n = 57) ...