A Phase 2 interventional study of ecallantide - Kallikrein inhibitor that blocks the production of bradykinin in Angioedema, sponsored by Bernstein, Jonathan A., M.D.. Status unknown at 3 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-03-09.
Sponsored by Bernstein, Jonathan A., M.D. · Phase 2, Interventional, and Treatment
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.
164 studies on the registry are indexed under Angioedema; 19 are open to participants now.
This study's planned enrollment of 50 is above the median of 44 across 111 interventional studies indexed under Angioedema.
Browse Angioedema studies →Bernstein, Jonathan A., M.D. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: ecallantide - Kallikrein inhibitor that blocks the production of bradykinin
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.
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
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
This study is status unknown, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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Bernstein, Jonathan A., M.D.