Clinical trial NCT00432510: Pharmacokinetics of C1 Esterase Inhibitor in Hereditary Angioedema Subjects
Official title: Protocol LEVP2006-5: Pharmacokinetics of C1INH-nf in Hereditary Angioedema Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hereditary Angioedema
Keywords: Hereditary angioedema
C1 esterase inhibitor (human)
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2007-02-08
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 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

Primary outcomes:
measure: PK will be analyzed by means of incremental recovery, in vivo half-life, area under the curve, clearance, and mean residence time.
timeFrame: 1 week
measure: 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.
timeFrame: 1 week
Secondary outcomes:
measure: Number and severity of adverse events.
timeFrame: 3 months
measure: Change in clinical laboratory safety parameters from pre- to post-infusion.
timeFrame: 3 months
measure: Change in vital signs from pre- to post-infusion.
timeFrame: 30 minutes (Single Dose), 90 minutes (First Dose Followed by Second Dose)
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: Walnut Creek
country: United States
facility: Allergy and Asthma Clinical Research, Inc.
state: California
city: Atlanta
country: United States
facility: Family Allergy and Asthma Center
state: Georgia
city: Wheaton
country: United States
facility: Institute for Asthma and Allergy
state: Maryland
city: Hershey
country: United States
facility: Penn State University
state: Pennsylvania
city: Dallas
country: United States
facility: AARA Research Center
state: Texas
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: