An International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Trial on the Effects of EA-230 on the Length of Hospital Stay Following On-Pump Coronary Artery Bypass Grafting Surgery

Overview

Sponsor-declared trial summary

Key facts

Sponsor

EBI Anti Sepsis B.V.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Decision date (initial)

2026-04-29

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

The primary objective of this trial is to assess the effect of EA-230 on the required postoperative hospital Length of Stay (LoS)

Secondary objectives 6

1. To assess the effect of EA-230 on the required postoperative ICU Length of Stay (LoS)
2. To assess the effect of EA-230 on the actual ICU and Hospital Length of Stay (LoS)
3. To assess the effect of EA-230 on the duration of moderate and severe Post Operative Complications (PoC's)
4. To assess the effect of EA-230 on hemodynamic stability.
5. To assess the pharmacokinetic (PK) plateau values of EA-230.
6. To assess the safety of EA-230.

Conditions and MedDRA coding

Coronary artery disease

Regulatory references

Scientific advice from competent authorities

European Medicines Agency, Food And Drug Administration

Plan to share IPD

Yes

IPD plan description

Efficacy

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Patients aged ≥18 years, both male and female.
2. Patients scheduled for elective on-pump CABG with at least 3 bypasses, with or without valve replacement.
3. For women of childbearing potential (WOCBP), agree to use adequate contraception from enrollment and up to 28 days after IMP administration, and must have a negative pregnancy test prior to entry into the trial
4. For male patients, agree to use adequate contraception and refrain from donating sperm from enrollment and up to 28 days after IMP administration.
5. Willing and able to give written informed consent

Exclusion criteria 21

1. Patients undergoing non-elective on-pump CABG (i.e., emergency surgery). Emergency surgery is defined as planned surgery within 24 hours of diagnosis.
2. Cardiogenic shock or hemodynamic instability that requires inotropes, vasopressors, or other mechanical devices, such as an intra-aortic balloon counter-pulsation (IABP), within 24 hours prior to surgery.
3. Use of a left ventricular assist device (LVAD), or intra-aortic balloon pump or other cardiac devices, within 7 days prior to surgery.
4. A requirement for any of the following within 7 days prior to surgery: defibrillator or permanent pacemaker, mechanical ventilation, IABP, LVAD, or other forms of mechanical circulatory support.
5. Required cardiopulmonary resuscitation within 14 days prior to cardiac surgery.
6. Known chronic liver disorder with Child-Pugh C classification.
7. Confirmed or treated endocarditis requiring antimicrobial or antiviral treatment within 30 days prior to surgery or other current active infection requiring antimicrobial or antiviral treatment within 14 days prior to surgery.
8. Ongoing sepsis (as defined by SEPSIS-3) within 2 weeks of screening or, in the opinion of the investigator, an untreated clinically significant infection (viral or bacterial) prior to or at Screening and before randomization.
9. Immuno-compromised patients, as self-reported or as observed in medical records, including patients: a. with solid organ transplantation. b. known to be positive for human immunodeficiency virus (HIV). c. that use immunosuppressive drugs or have received recent chemotherapy, at the discretion of the Investigator and including patients; i. with active malignancy who have undergone chemotherapy within 30 days prior to trial entry. ii. receiving chronic corticosteroid treatment equivalent to a prednisone dose of 10 mg or higher per day, within 30 days prior to trial entry, or an equivalent dose of another corticosteroid or any other anti-inflammatory or inflammation-suppressing medications such as interleukin blockers, methotrexate or similar therapies. Non-Steroidal Anti-Inflammatory Drugs are not exclusionary.
10. Patients with hematological disorders (known disorders from myeloid and/or lymphoid origin, leucopenia (both active and in remission)).
11. Known severe renal disease requiring dialysis, or a known estimated Glomerular Filtration Rate (eGFR) prior to admission of < 20 ml/min/1.73 m2.
12. Women who are pregnant, breastfeeding or planning to become pregnant during the trial or within 28 days after IMP administration.
13. Previous receipt of EA-230.
14. Known hypersensitivity to the IMP.
15. Use of any investigational drug within 1 month or 5 half-lives of said investigational drug (whichever is longer) prior to IMP administration in this trial. Participation in an observational clinical trial is not exclusionary.
16. Patients (or partners of patients) not willing to use a reliable method of contraception from enrollment and up to 28 days after IMP administration.
17. Patients who are unable to communicate effectively in the local language of the trial site, at the discretion of the Investigator.
18. Inability to personally provide written informed consent
19. Known or suspected of not being able to comply with the trial protocol, at the discretion of the Investigator.
20. Any other condition which, in the Investigator’s opinion, will interfere with completion of the trial.
21. Being an employee of the Investigator or trial site with direct involvement in the proposed trial or other studies under the direction of that Investigator or trial site or being a family member of an employee of the Investigator with direct involvement in the proposed trial.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. As measured by the median postoperative duration, from the moment of first incision until the time when a patient is eligible to be discharged from the hospital, compared between treatment arms, according to the definitions provided in Summary Table 4. ICU and Hospital Discharge Criteria.

Secondary endpoints 6

1. As measured by the median postoperative duration, from the moment of first incision until the time when a patient is eligible to be discharged from the ICU and transferred to the general ward, compared between treatment arms, according to the definitions provided in Summary Table 4. ICU and Hospital Discharge Criteria.
2. As measured by the median postoperative duration, from the moment of first incision until the time when a patient is actually discharged from the ICU, and discharged from the hospital, respectively, compared between treatment arms.
3. As measured by the median cumulative duration of moderate and severe Single Organ Outcome Measures (SOOMs) according to the European Perioperative Clinical Outcome (EPCO) definitions during the trial compared between treatment arms.
4. As measured by: A. Median cumulative Net Fluid Balance (NFB) at the start of Investigational Medicinal Product (IMP) administration (T0) and up to 24 and 48 hours thereafter, compared between treatment arms. B. Cumulative dose of vasopressors and inotropes used and vasopressor-inotropic scores up to 0, 24 and 48 hours after IMP administration, compared between treatment arms.
5. As determined by: A. Blood plasma levels of EA-230 measured just before the end of infusion (T4) in all patients. B. Blood plasma levels of EA-230 measured at T0, T0.5, T1, T2, T3 and T4 in a subset of patients .
6. As measured by the Incidence of treatment-emergent (Serious) Adverse Events ((S)AEs) and Adverse Drug Reactions (ADRs) during the trial period.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

EBI Anti Sepsis B.V.

Sponsor organisation

EBI Anti Sepsis B.V.

Address

Kneuterdijk 2

City

's-Gravenhage

Postcode

2514 EN

Country

Netherlands

Scientific contact point

Organisation

EBI Anti Sepsis B.V.

Contact name

Elke van Wachem

Public contact point

Organisation

EBI Anti Sepsis B.V.

Contact name

Elke van Wachem

Locations

2 EU/EEA countries · 3 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 12 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications