The trial enrolls patients undergoing a complex cardiac surgery. The primary goal of the trial is to evaluate the pharmacodynamic dose response relationship of the monoclonal antibody IFX-1 in these patients. In addition, this trial further aims to characterize the safety and the pharmacokinetics of IFX-1 as well as to collect first data on its efficacy on clinical surrogate endpoints.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
116
Study Site
Aachen, Germany
Study Site
Dortmund, Germany
Study Site
Dresden, Germany
Study Site
Freiburg im Breisgau, Germany
Peak level of IL-6
Time frame: From prior study drug administration until 24h after start of cardiopulmonary bypass (CPB) (CPB)
Plasma concentration of IFX-1 at each timepoint measured
Time frame: Data will be collected at the following approximate time points: prior study drug administration; 30 min after start of infusion; up to 10 min after cessation of CPB; 3h, 12h, 24h, 48h, 96h, and 168h after start of CPB; Day 15
Maximum observed concentration (Cmax) of IFX-1
Time frame: Data will be collected at the following approximate time points: prior study drug administration; 30 min after start of infusion; up to 10 min after cessation of CPB; 3h, 12h, 24h, 48h, 96h, and 168h after start of CPB; Day 15
Area under the curve (AUC) of plasma concentration of IFX-1
Time frame: Data will be collected at the following approximate time points: prior study drug administration; 30 min after start of infusion; up to 10 min after cessation of CPB; 3h, 12h, 24h, 48h, 96h, and 168h after start of CPB; Day 15
Plasma concentration of free, detectable C5a at each timepoint measured
Time frame: Data will be collected at the following approximate time points: prior study drug administration, prior start of CPB, up to 10 min after cessation of CPB; 3h, 6h, 12h, 24h, 48h, 96h, and 168h after start of CPB; Day 15
Serum levels of CH50 at each timepoint measured
Time frame: Data will be collected at the following approximate time points: prior study drug administration, prior start of CPB, up to 10 min after cessation of CPB; 3h, 6h, 12h, 24h, 48h, 96h, and 168h after start of CPB; Day 15
Serum levels of IL-6 compared to baseline
Time frame: Data will be collected at the following approximate time points: prior study drug administration, up to 10 min after cessation of CPB; 3h, 6h, 12h, 24h, 48h, and 96h after start of CPB; Day 15
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Study Site
Heidelberg, Germany
Study Site
Jena, Germany
Study Site
Kiel, Germany
Study Site
Leipzig, Germany
Study Site
Trier, Germany
Study Site
Tübingen, Germany
Serum levels of IL-8 compared to baseline
Time frame: Data will be collected at the following approximate time points: prior study drug administration, up to 10 min after cessation of CPB; 3h, 6h, 12h, 24h, 48h, and 96h after start of CPB; Day 15
Incidence of patients with Adverse Events (AEs) and Serious Adverse Events (SAEs) until Day 29
Time frame: From screening visit until Day 29
Number of patients with detection of anti-drug-antibodies
Time frame: Up to Day 15
Number of patients that are successfully extubated 24h after end of surgery
Time frame: 24h after end of surgery
Number of patients with consecutive invasive ventilation for more than 48h after end of surgery
Time frame: 48h after end of surgery
Number of patients that are weaned of any vasopressor use 24h after end of surgery
Time frame: 24h after end of surgery
Number of patients with SIRS 24h, 48h and 96h after start of CPB
Time frame: 24h, 48h and 96h after start of CPB