NCT01467947

Postmarketing Immunogenicity Study in HAE Subjects Treated With Berinert

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) Attacks Treated With Berinert® , a C1-esterase Inhibitor

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: CSL Behring · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hereditary Angioedema Types I and II

Interventions

Type	Name	Description
BIOLOGICAL	Berinert, lyophilizate for IV application containing 500 IU C1-INH to be reconstituted with 10 mL water for injection	Individual treatment duration per subject is 9 months, irrespective of the number of treated attacks. Each attack that occurs in this time frame will be treated with 20 IU Berinert/kg body weight.

Timeline

• Start date: 2011-11-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2011-11-09
• Last updated: 2017-02-06
• Results posted: 2015-11-16

Locations

4 sites across 4 countries: Bulgaria, Hungary, Poland, Romania