drugset / Trial / NCT01343823

Evaluation of Ecallantide for Treatment of Angiotensin Converting Enzyme (ACE) Inhibitor Induced Angioedema

NCT01343823 ↗

Phase 2 Terminated 79 enrolled Shire
RandomizedParallel-groupQuadruple-blindTreatment

Summary

A double-blind, randomized, controlled trial comparing the safety and effectiveness of conventional therapy with ecallantide to conventional therapy with placebo.

Timeline

Start
2011-06-01
Primary completion
2012-06-01
Completion
2012-06-01

Outcome

Outcome not reported

Stopped: “Interim analysis suggested a trend favoring ecallantide; observed response rate to placebo was substantially higher than described in medical literature.”

Drugs

EvaluationDrugModalityDoseRoute
Comparator ecallantide Protein / enzyme biologic 10 mg Subcutaneous
Comparator ecallantide Protein / enzyme biologic 30 mg Subcutaneous
Comparator ecallantide Protein / enzyme biologic 60 mg Subcutaneous