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

Exponential Biotherapies Inc.0 个研究点目标入组 160 人开始时间: 2016年2月11日最近更新: 2020年11月30日

试验速览

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•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

•1.Immune compromised
•Solid organ transplantation
•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.

发起方