Clinical Trial: Pharmacokinetics of C1 Esterase Inhibitor in Hereditary Angioedema Subjects
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Protocol LEVP2006-5: Pharmacokinetics of C1INH-nf in Hereditary Angioedema Subjects
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 Summary:
Sponsor: Shire
Current Primary Outcome:
- 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 ]
Original Primary Outcome:
- Pharmacokinetics will be analyzed by means of incremental recovery, in vivo half-life, area-under-curve (AUC), clearance and mean residence time (MRT).
- C1 inhibitor (functional and antigenic) and C4 levels will be measured both at a US CLIA certified laboratory as well as at the research division of the Sanquin Blood Supply Foundation (Sanquin).
Current Secondary Outcome:
- 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) ]
Original Secondary Outcome: Safety will be assessed by the number and severity of adverse experiences, and changes in clinical laboratory safety parameters and vital signs from pre to post infusion
Information By: Shire
Dates:
Date Received: February 7, 2007
Date Started: October 2006
Date Completion:
Last Updated: March 19, 2014
Last Verified: March 2014
