Evaluation of Ecallantide for the Acute Treatment of Angiotensin Converting Enzyme Inhibitor Induced Angioedema
Status:
Unknown status
Trial end date:
2013-12-01
Target enrollment:
Participant gender:
Summary
The investigators will conduct a double-blind, randomized controlled trial comparing the
safety and effectiveness of ecallantide to conventional therapy. A rescue cross-over design
will be used such that patients failing to improve on standard therapy will additionally be
treated with ecallantide. Therefore, a historical control cohort will be enrolled for
analysis of secondary endpoints. In addition, since some patients treated with conventional
therapy may improve rapidly and therefore not be eligible for inclusion in the study, the
investigators will enroll these patients as an observational arm to enable the conduct of
sensitivity analysis.