Clinical Trial: Postmarketing Immunogenicity Study in HAE Subjects Treated With Berinert

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Prospective Open-label Uncontrolled Multi-center Post-marketing Study to Assess Inhibitory Antibody Formation in Subjects With Congenital C1-INH Deficiency and Acute Hereditary Angioedema (HAE) Attack

Brief Summary: This is a prospective, international, multi-center, non-randomized, single arm, open-label, postmarketing study to investigate the formation of inhibitory anti-C1-INH antibodies in HAE subjects treated intravenously with Berinert. Individual treatment duration per subject is 9 months, irrespective of the number of treated attacks. All subjects will receive 20 IU Berinert/kg body weight per attack.

Detailed Summary:
Sponsor: CSL Behring

Current Primary Outcome: Number of Subjects With Inhibitory Anti-C1-esterase-inhibitor Antibodies [ Time Frame: Baseline to approximately 9 months ]

Subjects with no positive baseline result and at least one positive post-baseline result for inhibitory anti-C1-INH antibodies.


Original Primary Outcome: Incidence of subjects with inhibitory anti-C1-esterase-inhibitor antibodies [ Time Frame: Period of 9 months (baseline to Day 273) ]

Current Secondary Outcome: Number of Subjects With Any (Inhibitory or Non-inhibitory) Anti-C1-esterase-inhibitor Antibodies [ Time Frame: Baseline to approximately 9 months ]

Subjects with at least one positive result for inhibitory or non-inhibitory anti-C1-INH antibodies.


Original Secondary Outcome: Proportion of subjects with any (inhibitory or non-inhibitory) anti-C1-esterase-inhibitor antibodies [ Time Frame: Period of 9 months (baseline to Day 273) ]

Information By: CSL Behring

Dates:
Date Received: November 7, 2011
Date Started: November 2011
Date Completion:
Last Updated: December 12, 2016
Last Verified: October 2015