Conditions: Hereditary Angioedema Angioneurotic Edema Genetic Disorders
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 75
Healthy volunteers: no

Brief summary:
Hereditary angioedema ("HAE") is a genetic disorder characterized by sudden recurrent attacks of local swelling (angioedema). These attacks are often painful and disabling, and, in some cases, life-threatening. "HAE" is caused by mutations in the "C1INH" gene that leads to a decrease in the blood level of functional "C1INH". This multi-center study was designed to assess the safety and tolerability, efficacy and pharmacodynamics/ pharmacokinetics of recombinant human C1 inhibitor ("rhC1INH") in the treatment of acute hereditary angioedema attacks.

Detailed description:
A prospectively planned interim analysis will be performed on the double-blind data.

Arms:
arm 1: 100 IU/kg recombinant human C1 inhibitor arm 2: Saline solution

Interventions: intervention 1: recombinant human C1 inhibitor intervention 2: Placebo
Intervention descriptions: intervention 1: IV intervention 2: IV

Protocol document: