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

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

Copyright © 2011 Elsevier Inc. All rights reserved.

Bibliographische Detailangaben
Veröffentlicht in:Clinical immunology (Orlando, Fla.). - 1999. - 142(2012), 3 vom: 01. März, Seite 280-90
1. Verfasser: Hofstra, J J (VerfasserIn)
Weitere Verfasser: Kleine Budde, I, van Twuyver, E, Choi, G, Levi, M, Leebeek, F W G, de Monchy, J G R, Ypma, P F, Keizer, R J, Huitema, A D R, Strengers, P F W
Format: Online-Aufsatz
Sprache:English
Veröffentlicht: 2012
Zugriff auf das übergeordnete Werk:Clinical immunology (Orlando, Fla.)
Schlagworte:Clinical Trial, Phase II Clinical Trial, Phase III Journal Article Multicenter Study Randomized Controlled Trial Complement C1 Inhibitor Protein
Beschreibung
Zusammenfassung:Copyright © 2011 Elsevier Inc. All rights reserved.
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
Beschreibung:Date Completed 12.04.2012
Date Revised 13.06.2012
published: Print-Electronic
Citation Status MEDLINE
ISSN:1521-7035
DOI:10.1016/j.clim.2011.11.005