Hereditary Angioedema
Conditions
Keywords
Hereditary angioedema, C1 esterase inhibitor (human)
Brief summary
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.
Interventions
Sponsors
Shire
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Enrolled in LEVP2005-1 (current or in the past)
Exclusion criteria
* C1 inhibitor infusion within the last 7 days * Signs of any HAE attack * HAE attack within 7 days before actual infusion of C1INH-nf * Change in the dosage of androgens in the last 14 days before the study * Use of antifibrinolytics in the last 7 days before the study * Change in oral conceptive medication in the last two months before the study * History of clinically relevant antibody development to C1 inhibitor * Use of oral anticoagulant medication in the last 14 days * Use of heparin within the last two days prior to the study * History of allergic reaction to C1 inhibitor or other blood products * Current participation (or within the past 90 days) in any investigational drug study other than those sponsored by Lev Pharmaceuticals * Pregnancy or lactation * B-cell malignancy * Any clinically significant medical condition, such as renal failure, that in the opinion of the investigator would interfere with the subject's ability to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK will be analyzed by means of incremental recovery, in vivo half-life, area under the curve, clearance, and mean residence time. | 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. | 1 week |
Secondary
| Measure | Time frame |
|---|---|
| Change in clinical laboratory safety parameters from pre- to post-infusion. | 3 months |
| Change in vital signs from pre- to post-infusion. | 30 minutes (Single Dose), 90 minutes (First Dose Followed by Second Dose) |
| Number and severity of adverse events. | 3 months |
Countries
United States
Outcome results
None listed