Evaluation of pharmacokinetics, efficacy and safety of Immunate® solvent detergent in previously treated patients with severe haemophilia A

L. Nemes, T. Lissitchkov, A. Klukowska, G. Dobaczewski, V. Komrska, R. Zimmermann, G. Auerswald, W. Engl, B. Pavlova, B. Abbühl, Hartmut J. Ehrlich

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8 Citations (Scopus)

Abstract

Immunate® Solvent Detergent (S/D) is a plasma derived, purified, human factor VIII (FVIII) - von Willebrand factor (VWF) complex subjected to two virus inactivation/removal processes: S/D and vapor heat treatment. This prospective, multicentre, three-part clinical study evaluated the pharmacokinetics (in comparison to the predecessor product Immunate®), efficacy and safety of Immunate® S/D in 56 previously treated patients with severe haemophilia A. Subjects received Immunate® S/D on-demand, as a prophylactic regimen or both. The results of the pharmacokinetic population demonstrate that Immunate® and Immunate® S/D were equivalent with respect to the FVIII - and to the retrospectively VWF - parameters assessed. A total of 623 bleeding episodes were reported in 47/56 subjects. The duration of prophylaxis ranged from 0.1-5.2 months with a total of 175.6 months. The median number of bleeds per month in subjects on prophylaxis was 0 (range 0-10). Ninety-six percent of bleeding episodes were rated as having an excellent or good response. For most bleeding episodes (89%), subjects required only one infusion with a mean dose of 29.6 IU kg-1. No FVIII inhibitory antibodies were observed in any subject. No related serious adverse events were reported. Thus, the introduction of S/D treatment did not alter the PK characteristics and function of VWF and FVIII molecules of Immunate® S/D which is effective and safe for treatment of bleeding episodes, management of surgical procedures, and prophylaxis.

Original languageEnglish
Pages (from-to)9-11
Number of pages3
JournalHaemophilia
Volume13
Issue number1
DOIs
Publication statusPublished - Jan 1 2007

Keywords

  • Efficacy
  • Immunate®
  • Immunate® S/D
  • PTP
  • Pharmacokinetics
  • Safety

ASJC Scopus subject areas

  • Hematology
  • Genetics(clinical)

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    Nemes, L., Lissitchkov, T., Klukowska, A., Dobaczewski, G., Komrska, V., Zimmermann, R., Auerswald, G., Engl, W., Pavlova, B., Abbühl, B., & Ehrlich, H. J. (2007). Evaluation of pharmacokinetics, efficacy and safety of Immunate® solvent detergent in previously treated patients with severe haemophilia A. Haemophilia, 13(1), 9-11. https://doi.org/10.1111/j.1365-2516.2006.01412.x