Pharmacokinetics of C1 Esterase Inhibitor in Hereditary Angioedema Subjects
Phase 1
Completed
- Conditions
- Hereditary Angioedema
- Interventions
- Drug: C1 esterase inhibitor [human] (C1INH-nf)
- Registration Number
- NCT00432510
- Lead Sponsor
- Shire
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Single Dose C1 esterase inhibitor [human] (C1INH-nf) 1,000 Units (U) of C1INH-nf administered intravenously (IV). First Dose Followed by Second Dose C1 esterase inhibitor [human] (C1INH-nf) 1,000 U of C1INH-nf administered IV, followed by a second 1,000 U dose 60 minutes later.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Number and severity of adverse events. 3 months 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)
Trial Locations
- Locations (6)
Allergy and Asthma Clinical Research, Inc.
🇺🇸Walnut Creek, California, 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
University of California, San Diego
🇺🇸San Diego, California, United States
Family Allergy and Asthma Center
🇺🇸Atlanta, Georgia, United States