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

Research output: Contribution to journalArticle

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 2007

Fingerprint

Hemophilia A
Detergents
Pharmacokinetics
Safety
Hemorrhage
Factor VIII
Virus Inactivation
von Willebrand Factor
Therapeutics
Hot Temperature
Antibodies
Population

Keywords

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

ASJC Scopus subject areas

  • Hematology

Cite this

Evaluation of pharmacokinetics, efficacy and safety of Immunate® solvent detergent in previously treated patients with severe haemophilia A. / Nemes, L.; Lissitchkov, T.; Klukowska, A.; Dobaczewski, G.; Komrska, V.; Zimmermann, R.; Auerswald, G.; Engl, W.; Pavlova, B.; Abbühl, B.; Ehrlich, Hartmut J.

In: Haemophilia, Vol. 13, No. 1, 01.2007, p. 9-11.

Research output: Contribution to journalArticle

Nemes, L, Lissitchkov, T, Klukowska, A, Dobaczewski, G, Komrska, V, Zimmermann, R, Auerswald, G, Engl, W, Pavlova, B, Abbühl, B & Ehrlich, HJ 2007, 'Evaluation of pharmacokinetics, efficacy and safety of Immunate® solvent detergent in previously treated patients with severe haemophilia A', Haemophilia, vol. 13, no. 1, pp. 9-11. https://doi.org/10.1111/j.1365-2516.2006.01412.x
Nemes, L. ; Lissitchkov, T. ; Klukowska, A. ; Dobaczewski, G. ; Komrska, V. ; Zimmermann, R. ; Auerswald, G. ; Engl, W. ; Pavlova, B. ; Abbühl, B. ; Ehrlich, Hartmut J. / Evaluation of pharmacokinetics, efficacy and safety of Immunate® solvent detergent in previously treated patients with severe haemophilia A. In: Haemophilia. 2007 ; Vol. 13, No. 1. pp. 9-11.
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AU - Dobaczewski, G.

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AU - Zimmermann, R.

AU - Auerswald, G.

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AU - Ehrlich, Hartmut J.

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