Clinical Trial: Evaluation of Ecallantide for the Acute Treatment of Angiotensin Converting Enzyme Inhibitor Induced Angioedema

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Evaluation of Ecallantide for Acute Treatment of Angiotensin Converting Enzyme Inhibitor Induced Angioedema

Brief 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.

Detailed Summary:
Sponsor: Bernstein, Jonathan A., M.D.

Current Primary Outcome: Objective criteria that allow for discharge directly from the ED at or before 4 hours:(stable vital signs, no evidence of stridor, dysphagia or drooling, edema has regressed to or did not progress beyond Class I. [ Time Frame: 18 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Time to meet objective discharge criteria, Physician assessment of angioedema improvement measured using the Symptom Complex Response Assessment at 2 hours post-treatment and 4 hours post-treatment. [ Time Frame: 18 months ]

Original Secondary Outcome: Same as current

Information By: Bernstein, Jonathan A., M.D.

Dates:
Date Received: December 18, 2009
Date Started: May 2010
Date Completion: December 2013
Last Updated: March 8, 2012
Last Verified: March 2012