Randomized double blind placebo-controlled phase II study on the effects of EA-230 on the innate immune response following on-pump cardiac surgery

Phase 2

Recruiting

• Conditions: immune system; Inflammatory repsonse; 10027665; 10038430

• Registration Number: NL-OMON42527
• Lead Sponsor: Exponential Biotherapies Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 160

Inclusion Criteria

1. Patients scheduled for elective on-pump 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 years, 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. Immune compromised;• 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 < 4x10^9/L);4. Use of iohexol contrast <48 hours before start of the first study procedure ;5. Known hypersensitivity to any excipients of the drug formulations used;6. Treatment with investigational drugs or participation in any other intervention clinical trial within 30 days prior to study drug administration;7. Inability to personally provide written informed consent (e.g. for linguistic or mental reasons) ;8. Known or suspected of not being able to comply with the trial protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety:<br /><br>• Adverse events<br /><br>• Vital signs (blood pressure and heart rate)<br /><br>• Safety laboratory parameters (Hb, Ht, leucocytes, thrombocytes, leucocyte<br /><br>differential blood count, sodium, potassium, creatinine, urea, alkaline<br /><br>phosphatase, ALT, AST, &gamma;GT, CK, CRP)</p><br>