NCT00457015

Efficacy Study of DX-88 (Ecallantide) to Treat Acute Attacks of Hereditary Angioedema (HAE)

EDEMA4: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of DX-88 (Ecallantide) for the Treatment of Acute Attacks of Hereditary Angioedema

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of DX-88 (ecallantide) versus placebo in the treatment of moderate to severe acute attacks of hereditary angioedema.

Detailed description

This is a randomized placebo-controlled trial. The study is designed to assess the efficacy and safety of 30 mg subcutaneous ecallantide versus placebo in the treatment of moderate to severe acute attacks of hereditary angioedema. This study is conducted under Special Protocol Assessment with the FDA and is designed to provide pivotal efficacy data on ecallantide. These data are intended to support the marketing authorization of ecallantide in the treatment of acute attacks of hereditary angioedema. Efficacy and safety of ecallantide will be evaluated in this study.

Conditions

• Hereditary Angioedema (HAE)

Interventions

Type	Name	Description
DRUG	ecallantide	dose of 30 mg (10 mg/ml) given as 3 subcutaneous injections.
DRUG	Phosphate Buffer Saline (PBS), pH 7.0	given as three 1mL subcutaneous injections.

Timeline

• Start date: 2007-04-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2007-04-05
• Last updated: 2021-06-08
• Results posted: 2010-05-04

Locations

45 sites across 3 countries: United States, Canada, Jordan