Immunomodulation of EA-230 Following On-pump Coronary Artery Bypass Grafting (CABG)

• Status: Unknown status
• Trial end date: 2018-10-01
• Target enrollment: 0
• Participant gender: All

Summary

EA-230 is a newly developed synthetic compound with anti-inflammatory properties, it is a linear tetrapeptide derived from the human chorionic gonadotropin hormone (hCG). Recently, its immunomodulatory effects in humans were confirmed in a phase I trial and an optimal dose was established. To establish this anti-inflammatory effect in a selected patient population and assess clinical outcome, a combined phase IIa/IIb trial will be conducted with patients undergoing cardiac surgery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University
• Collaborator: Exponential Biotherapies Inc.

Criteria

Inclusion Criteria:

1. Patients scheduled for elective on-pump CABG surgery.

• Part 1: 60 patients undergoing CABG surgery, of which circa 40 low risk patients without valve replacement (range: 35-45)

• Part 2: CABG surgery with or without valve replacement

2. Written informed consent to participate in this trial prior to any study-mandated procedure.

3. Patients aged >18, both male and female.

4. Patients have to agree to use a reliable way of contraception with their partners from study entry until 3 months after study drug administration.

Exclusion Criteria:

1. Immunocompromised

• Solid organ transplantation

• Known HIV

• Pregnancy

• Systemic use of immunosuppressive drugs

2. Non-elective/Emergency surgery

3. Hematological disorders

• Known disorders from myeloid and/or lymphoid origin

• Leucopenia (leucocyte count < 4x109/L)

4. Known hypersensitivity to any excipients of the drug formulations used

5. Treatment with investigational drugs or participation in any other intervention clinical trial within 30 days prior to study drug administration

6. Inability to personally provide written informed consent (e.g. for linguistic or mental reasons)

7. Known or suspected of not being able to comply with the trial protocol.

In addition, for part 1 only (to select low-risk patients):

8. Euroscore II <4

9. Kidney function impairment: serum creatinine >200 µmol/L

10. Liver function impairment: Alanine transaminase/Aspartate transaminase (ALAT/ASAT) >3 times above upper level of reference range

11. Left ventricular dysfunction: Ejection fraction<35%

12. CABG procedure with valve replacement