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

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.

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