NCT00456508

Safety and Efficacy Study of Repeated Doses of DX-88 (Ecallantide) to Treat Attacks of Hereditary Angioedema (HAE)

Open-label Patient Continuation of DX-88 (Ecallantide) for Acute Hereditary Angioedema Attacks

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 147 (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 repeated doses of ecallantide in the treatment of acute attacks of hereditary angioedema and to allow HAE patients continued access to ecallantide. In addition, patients enrolled in DX-88/20 (EDEMA4) trial will be followed up and treated for subsequent attacks in this trial.

Detailed description

This is an open label trial. The study is designed to assess the efficacy and safety of 30 mg subcutaneous ecallantide in the treatment of acute attacks of hereditary angioedema. This study is designed to provide efficacy and safety data on repeated use of 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	solution for SC injection, one 30 mg dose per HAE attack

Timeline

• Start date: 2007-04-01
• Primary completion: 2010-06-01
• Completion: 2010-09-01
• First posted: 2007-04-05
• Last updated: 2021-06-08
• Results posted: 2012-12-28

Locations

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