NCT00292981

C1 Esterase Inhibitor in Hereditary Angioedema (HAE)(Extension Study)

Open-label Extension Study of CE1145 (Human Pasteurized C1 Esterase Inhibitor Concentrate) in Subjects With Congenital C1-INH Deficiency and Acute HAE Attacks

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: CSL Behring · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

Summary

Hereditary angioedema (HAE) is a rare disorder characterized by congenital lack of functional C1 esterase inhibitor. If not treated adequately, the acute attacks of HAE can be life-threatening and may even result in fatalities, especially in case of involvement of the larynx.The planned extension study is designed to enrol subjects that participated in the pivotal study in order to provide them with C1-INH for treatment of acute HAE attacks for 24 months or until the licensing procedure for C1-INH is finalized, whatever comes first.

Conditions

• Hereditary Angioedema

Interventions

Type	Name	Description
DRUG	C1 Esterase Inhibitor	Lyophilisate containing approximately 500 U C1-INH to be reconstituted with 10 mL water for injection; Single Dose: 20 U/kg b.w. iv

Timeline

• Start date: 2005-08-01
• Primary completion: 2010-02-01
• Completion: 2010-05-01
• First posted: 2006-02-16
• Last updated: 2015-05-07
• Results posted: 2011-06-23

Locations

14 sites across 2 countries: United States, Canada