Status:
COMPLETED
Pharmacokinetics of C1 Esterase Inhibitor in Hereditary Angioedema Subjects
Lead Sponsor:
Shire
Conditions:
Hereditary Angioedema
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- Enrolled in LEVP2005-1 (current or in the past)
Exclusion
- 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
Key Trial Info
Start Date :
October 9 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2007
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00432510
Start Date
October 9 2006
End Date
February 28 2007
Last Update
June 3 2021
Active Locations (6)
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1
University of California, San Diego
San Diego, California, United States, 92093-0732
2
Allergy and Asthma Clinical Research, Inc.
Walnut Creek, California, United States, 94598
3
Family Allergy and Asthma Center
Atlanta, Georgia, United States, 30342
4
Institute for Asthma and Allergy
Wheaton, Maryland, United States, 20902