Clinical Trial: A Study to Evaluate the Safety and Pharmacokinetics of Two Formulations of C1-esterase Inhibitor
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized, Double-blind, Single-center, Cross-over Study to Evaluate the Safety, Bioavailability and Pharmacokinetics of Two Formulations of C1-esterase Inhibitor Administered Intravenously
Brief Summary: A new formulation of Berinert (CSL830) is being investigated for the management of hereditary angioedema (HAE). The main aim of the study is to assess the safety of a single 1500 IU dose of the new formulation of Berinert. This study will also look at the pharmacokinetics of CSL830 relative to Berinert currently on the market.
Detailed Summary:
Sponsor: CSL Behring
Current Primary Outcome: Incidence of adverse events (AEs) within 24 hours of CSL830 infusion [ Time Frame: From the start of infusion to 24 hours after the end of infusion ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Incidence of adverse events (AEs) within 10 days of the CSL830 infusion [ Time Frame: From the start of infusion to 10 days after the infusion ]
- Relative bioavailability of CSL830 versus Berinert - Cmax [ Time Frame: 240 hours ]Relative bioavailability in terms of maximum concentration (Cmax) of CSL830 versus Berinert
- Relative bioavailability of CSL830 versus Berinert - AUC [ Time Frame: 240 hours ]Relative bioavailability in terms of area under the curve from timepoint 0 to infinity (AUC0-∞) of CSL830 versus Berinert
Original Secondary Outcome: Same as current
Information By: CSL Behring
Dates:
Date Received: December 24, 2012
Date Started: January 2013
Date Completion:
Last Updated: April 4, 2013
Last Verified: April 2013
