Safety and Efficacy Study of CINRYZE for Prevention of Angioedema Attacks in Children Ages 6-11 With Hereditary Angioedema

A Phase 3, Multicenter, Randomized, Single-Blind, Dose-Ranging, Crossover Study to Evaluate the Safety and Efficacy of Intravenous Administration of CINRYZE® (C1 Esterase Inhibitor [Human]) for the Prevention of Angioedema Attacks in Children 6 to 11 Years of Age With Hereditary Angioedema

Primary Objective - To assess the relative efficacy of two dose levels of CINRYZE (500 Units and 1000 Units) administered by intravenous (IV) injection every 3 or 4 days to prevent angioedema attacks in children 6 to 11 years of age with hereditary angioedema (HAE).

Secondary Objectives - To assess the safety and tolerability, characterize the pharmacokinetics (PK) and pharmacodynamics (PD), and assess the immunogenicity of two dose levels of CINRYZE administered by IV injection in children 6 to 11 years of age with HAE.

Inclusion Criteria:

• Diagnosis of Type I or Type II HAE.
• History of angioedema attacks.

Exclusion Criteria:

• History of bleeding or clotting abnormality.
• Diagnosis of acquired angioedema or known to have C1 INH antibodies.
• History of allergic reaction to C1 esterase inhibitor or other blood products.
• Receipt of any experimental agents other than those required for prevention or treatment of angioedema attacks within 30 days prior to screening.