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

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CSL Behring
• Treatments: Complement C1 Inactivator Proteins; Complement C1 Inhibitor Protein; Complement C1s

Criteria

Key Inclusion Criteria:

• Documented congenital C1-INH deficiency

• Acute HAE attack

• Participation in base study CE1145_3001 (NCT00168103)

Key Exclusion Criteria:

• Acquired angioedema

• Treatment with any other investigational drug besides CE1145 in the last 30 days before study entry