Document Detail

Treatment of hereditary angioedema with nanofiltered C1-esterase inhibitor concentrate (Cetor®): multi-center phase II and III studies to assess pharmacokinetics, clinical efficacy and safety.
MedLine Citation:
PMID:  22197071     Owner:  NLM     Status:  MEDLINE    
From 1997, plasma-derived C1-inhibitor concentrate (Cetor®) has been available to HAE and AAE patients. Recently, a virus reducing 15 nm nanofiltration step has been introduced in the production process. A randomized, double-blind controlled cross-over study was performed to compare the pharmacokinetics (PK) of nanofiltered (C1-INH-NF) with conventional C1-inhibitor (C1-INH). Efficacy and safety were investigated in an open-label, on-demand and a prophylactic study. No differences in pharmacokinetic parameters between C1-INH and C1-INH-NF were found (13 non-symptomatic HAE patients). Both C1-inhibitor products equally increased plasma C4 levels. In the on-demand study, 14 acute angioedema attacks in 8 patients were analyzed. In the prophylactic study, 1 AAE and 5 HAE patients experienced in total 31 attacks during 748 observation days. In total 180,000 units of C1-INH-NF were administered. No product-related adverse events occurred, and no anti-C1-antibodies were induced. Nanofiltration in the production process of C1-inhibitor did not affect the pharmacokinetics, efficacy, and safety.
J J Hofstra; I Kleine Budde; E van Twuyver; G Choi; M Levi; F W G Leebeek; J G R de Monchy; P F Ypma; R J Keizer; A D R Huitema; P F W Strengers
Publication Detail:
Type:  Clinical Trial, Phase II; Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial     Date:  2011-11-16
Journal Detail:
Title:  Clinical immunology (Orlando, Fla.)     Volume:  142     ISSN:  1521-7035     ISO Abbreviation:  Clin. Immunol.     Publication Date:  2012 Mar 
Date Detail:
Created Date:  2012-02-27     Completed Date:  2012-04-12     Revised Date:  2012-06-13    
Medline Journal Info:
Nlm Unique ID:  100883537     Medline TA:  Clin Immunol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  280-90     Citation Subset:  IM    
Copyright Information:
Copyright © 2011 Elsevier Inc. All rights reserved.
Department of Internal Medicine, Academic Medical Centre, Amsterdam, The Netherlands.
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MeSH Terms
Angioedemas, Hereditary / drug therapy*,  prevention & control
Complement C1 Inhibitor Protein / adverse effects,  pharmacokinetics,  therapeutic use*
Middle Aged
Reg. No./Substance:
0/Complement C1 Inhibitor Protein

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