Conditions: Hereditary Angioedema
Keywords: C1 Inhibitor Hereditary angioedema Acute HAE attack
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 57
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: C1 Esterase Inhibitor
Intervention descriptions: intervention 1: Lyophilisate containing approximately 500 U C1-INH to be reconstituted with 10 mL water for injection; Single Dose: 20 U/kg b.w. iv

Protocol document: