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

• Status: Terminated
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shire
• Treatments: Angiotensin-Converting Enzyme Inhibitors; Ecallantide

Criteria

Inclusion Criteria:

• Males and females 18 years of age or older

• Must currently be on ACE inhibitor therapy and have received a dose within 36 hours

• Presenting with ACEIA of the head/neck region within 12 hours after onset

• All females must have a negative urine pregnancy test prior to administration of the study drug. Those who have had a total hysterectomy, bilateral oophorectomy or are two years post-menopausal do not require a pregnancy test.

Exclusion Criteria:

• Hypersensitivity to ecallantide

• Pregnancy or breast feeding

• Patients who have had angioedema and were not concurrently on an ACE inhibitor

• Patients exhibiting urticaria

• Patients who are intubated or who have a tracheostomy related to the current episode of angioedema

• Opinion of the investigator that the patient would not be a good candidate

• Participation in another investigational study within 30 days prior to enrollment