NCT00262080

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

A Double-blind, Placebo-controlled Study (72 Patients, Randomized 1:1) Followed by a Repeat-dosing Phase to Assess the Efficacy and Safety of DX-88 (Ecallantide; Recombinant Plasma Kallikrein Inhibitor) for the Treatment of Acute Attacks of Hereditary Angioedema

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 10 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if a subcutaneous dose of DX-88 (ecallantide; an investigational product) is safe and relieves symptoms of HAE in patients suffering from moderate to severe acute attacks of HAE.

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),	given as three 1mL subcutaneous injections.

Timeline

• Start date: 2005-12-31
• Primary completion: 2005-12-31
• Completion: 2007-02-28
• First posted: 2005-12-06
• Last updated: 2021-06-11
• Results posted: 2010-05-11

Locations

1 site across 1 country: United States