The study objective was to describe the pharmacokinetics (PK) of one or two doses of C1 esterase inhibitor (C1INH-nf) in hereditary angioedema (HAE) subjects who were not experiencing an HAE attack.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
27
University of California, San Diego
San Diego, California, United States
Allergy and Asthma Clinical Research, Inc.
Walnut Creek, California, United States
Family Allergy and Asthma Center
Atlanta, Georgia, United States
Institute for Asthma and Allergy
Wheaton, Maryland, United States
PK will be analyzed by means of incremental recovery, in vivo half-life, area under the curve, clearance, and mean residence time.
Time frame: 1 week
C1 inhibitor (functional and antigenic) and C4 antigen serum levels will be measured at a United States Clinical Laboratory Improvement Amendments-certified laboratory and the research division of Sanquin Blood Supply Foundation.
Time frame: 1 week
Number and severity of adverse events.
Time frame: 3 months
Change in clinical laboratory safety parameters from pre- to post-infusion.
Time frame: 3 months
Change in vital signs from pre- to post-infusion.
Time frame: 30 minutes (Single Dose), 90 minutes (First Dose Followed by Second Dose)
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Penn State University
Hershey, Pennsylvania, United States
AARA Research Center
Dallas, Texas, United States