The objectives of this study were to evaluate: (1) the dose response and (2) the pharmacokinetics (PK) and pharmacodynamics (PD) of intravenous (IV) administration of CINRYZE for the treatment of acute angioedema attacks in children above and below 25 kg and less than 12 years of age with hereditary angioedema (HAE); and (3) to determine the safety and tolerability following IV administration of CINRYZE in this study population.
Each subject received CINRYZE for treatment of a single acute angioedema attack.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Asthma & Allergy Associates, P.C.
Colorado Springs, Colorado, United States
University of South Florida Asthma, Allergy and Immunology Clinical Research Unit
Tampa, Florida, United States
Institute for Asthma and Allergy, PC
Chevy Chase, Maryland, United States
Presence of Unequivocal Beginning of Relief of the Defining Attack Symptom
Time frame: Within 4 hours following treatment
Time to Unequivocal Beginning of Relief of the Defining Attack Symptom
Time frame: Within 4 hours following treatment
Time to Complete Resolution of the Attack
Time frame: Within 1 week following treatment
Change in C1 Inhibitor (C1 INH) Antigen and Functional C1 INH Concentrations
Data was not reported due to change in planned analysis.
Time frame: Pre-dose, 2, 4, 8 hours post dose on Day 1; Day 2, 3, 5, 8
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