Pharmacokinetics of C1 Esterase Inhibitor in Hereditary Angioedema Subjects
Completed · Phase 1
Conditions studied: Hereditary Angioedema
In brief
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.
Key facts
- Study ID
- NCT00432510
- Run by
- Shire
- People needed
- 27
- Starts
- 2006-10-09
- Expected to finish
- 2007-02-28
- Last updated by the study team
- 2021-06-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Enrolled in LEVP2005-1 (current or in the past)
You may not qualify if…
- 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
Where it is running
- 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
- Penn State University — Hershey, Pennsylvania, United States
- AARA Research Center — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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