Conditions: Genetic Disorders Hereditary Angioedema
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 25
Healthy volunteers: no

Brief summary:
Hereditary angioedema ("HAE") is a disease characterized by recurrent tissue swelling affecting various body locations. Recent literature shows that patients with frequent attacks may benefit from long-term prophylaxis. This study aims to evaluate the safety and prophylactic effect of weekly administrations of 50 IU/kg recombinant C1 Inhibitor ("rhC1INH").

Detailed description:

Arms:
arm 1: Weekly administration of 50 IU/kg Recombinant Human C1 Inhibitor

Interventions: intervention 1: Recombinant Human C1 Inhibitor
Intervention descriptions: intervention 1: 50 IU/kg "rhC1INH", "IV" injection over 4 to 5 minutes, once weekly over an 8-week treatment period.

Protocol document: