Primary Objective: To evaluate the efficacy of recombinant human C1 inhibitor (rhC1INH) in the prophylaxis of angioedema attacks in patients with HAE Secondary Objective: To evaluate the safety and immunogenicity of recombinant human C1 inhibitor (rhC1INH) in the prophylaxis of angioedema attacks in patients with HAE
Study Design: This is a multi-center, randomized, double-blind, placebo-controlled, 3-period crossover study of rhC1INH in prophylaxis of angioedema attacks in patients with HAE. Medical screening (clinical and laboratory parameters) will be performed and patient medical history specific to HAE attacks will be collected to assess eligibility. Each patient will receive three 4 week periods of treatment twice weekly.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
32
University of South Florida Asthma, Allergy and Immunology Clinical Research Unit
Tampa, Florida, United States
University of South Florida, Asthma, Allergy & Immunology Clinical Research Unit
Tampa, Florida, United States
Washington University Division of Allergy and Immunology
St Louis, Missouri, United States
Number of HAE Attacks
Average number of HAE attacks normalized to a 28 day period
Time frame: 28 days
Number of Participants With Adverse Events
Number of participants that experienced Treatment Emergent Adverse Events observed in safety population
Time frame: 20 weeks
Percentage of Participants Achieving at Least 50% Reduction in Number of Attacks
Percentage of participants achieving at least 50% reduction in the number of attacks normalized to a 28-day period as compared to the placebo treatment period
Time frame: 28 days
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