NCT01036659

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Bernstein, Jonathan A., M.D. · Individual
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Angioedema

Interventions

Type	Name	Description
DRUG	ecallantide - Kallikrein inhibitor that blocks the production of bradykinin	subcutaneous dose of 30mg of ecallantide or placebo (three 10 mg SC injections at three different sites ((arms, legs, abdomen). Injections are not to be administered at the attack location.

Timeline

• Start date: 2010-05-01
• Primary completion: 2013-06-01
• Completion: 2013-12-01
• First posted: 2009-12-21
• Last updated: 2012-03-09

Locations

3 sites across 1 country: United States