drugset / Trial / NCT00785018

In Vivo Effects of C1-esterase Inhibitor on the Innate Immune Response During Human Endotoxemia

NCT00785018

Completed 20 enrolled Radboud University Medical Center
RandomizedParallel-groupTriple-blindBasic science

Summary

Excessive inflammation is associated with tissue damage caused by over-activation of the innate immune system. This can range from mild disease to extreme conditions such as multiple organ failure (MOF). In marked contrast to adaptive immunity which is very sensitive to immune modulators such as steroids, the innate immune system cannot be sufficiently targeted by currently available anti-inflammatory drugs. We hypothesize that C1-esterase inhibitor can modulate the innate immune response. In this study, human endotoxemia will be used as a model for inflammation. Subjects will, additionally to endotoxin, receive C1 esterase inhibitor or placebo. Blood will be sampled to determine the levels of markers of the innate immune response.

Timeline

Start
2008-11
Primary completion
2008-12
Completion
2009-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator CINRYZE Protein / enzyme biologic 100 iu/kg