NCT Number: NCT00432510
Pharmacokinetics of C1 Esterase Inhibitor in Hereditary Angioedema Subjects
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.
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
University of California, San Diego, San Diego, California, United States
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
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
Secondary outcomes
-
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)
Sponsors and collaborators
Lead sponsor
Shire
Industry
Registry information
Official study title
Protocol LEVP2006-5: Pharmacokinetics of C1INH-nf in Hereditary Angioedema Subjects
Important dates
- Study start
- 2006
- Primary completion
- 2007
- Study completion
- 2007
- First posted
- Feb 8, 2007
- Registry last updated
- Jun 3, 2021
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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