NCT01343823

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• ACE Inhibitor Induced Angioedema

Interventions

Type	Name	Description
DRUG	ecallantide 60 mg	Administered as two 3 mL SC injections, each containing 30 mg ecallantide
DRUG	ecallantide 30 mg	Administered as one 3 mL SC injection containing 30 mg ecallantide
DRUG	ecallantide 10 mg	Administered as one 3 mL SC injection containing 10 mg ecallantide.
DRUG	placebo	Administered as two SC 3 mL injections
DRUG	placebo match for 30 mg ecallantide arm	One 3 mL SC injection of matching placebo given to subjects randomized to the 30 mg ecallantide arm.
DRUG	placebo match for 10 mg ecallantide arm	One 3 mL SC injection of matching placebo given to subjects randomized to the 10 mg ecallantide arm.

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2011-04-28
• Last updated: 2021-06-11
• Results posted: 2013-11-18

Locations

39 sites across 1 country: United States