Study on the effects of EA-230 on the immune system following heart surgery

Phase 1

• Conditions: Therapeutic area: Body processes [G] - Immune system processes [G12]; Systemic inflammatory respons (SIRS) and associated acute kidney injury (AKI)

• Registration Number: EUCTR2015-005600-28-NL
• Lead Sponsor: Exponential Biotherapies Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-11
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• 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, 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 160
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 clinical trial of medicinal product
• Study Design: Not specified