Conditions: Hereditary Angioedema Angioneurotic Edema
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 77
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 lead to a decrease in the blood level of functional "C1INH". This multi-center study was designed to assess the safety and tolerability, efficacy, and pharmacokinetics/pharmacodynamics of recombinant human C1 inhibitor ("rhC1INH") in the treatment of acute hereditary angioedema attacks.

Funding Source - FDA OOPD

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: 50 IU/kg Recombinant human C1 inhibitor arm 3: None

Interventions: intervention 1: Recombinant Human C1 Inhibitor intervention 2: placebo
Intervention descriptions: intervention 1: IV intervention 2: saline solution

Protocol document: