2012-03-01
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
Publication
Publication
Clinical Immunology , Volume 142 - Issue 3 p. 280- 290
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.
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| doi.org/10.1016/j.clim.2011.11.005, hdl.handle.net/1765/37999 | |
| Clinical Immunology | |
| Organisation | Erasmus MC: University Medical Center Rotterdam |
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Hofstra, J. J., Budde, I., van Twuyver, E., Choi, G., Levi, M., Leebeek, F., de Monchy, J. G., Ypma, P., de Keizer, R. J. W., Huitema, A.& Strengers, P. F. W. (2012). 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. Clinical Immunology, 142(3), 280–290.https://doi.org/10.1016/j.clim.2011.11.005 |
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