Evaluation of pharmacokinetics, efficacy and safety of Immunate solvent detergent in previously treated patients with severe haemophilia A
| Autor: | L. Nemes, Toshko Lissitchkov, Hartmut J. Ehrlich, Werner Engl, B. Abbühl, R. Zimmermann, V. Komrska, Anna Klukowska, Borislava G. Pavlova, G. Auerswald, G. Dobaczewski |
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| Rok vydání: | 2007 |
| Předmět: |
animal diseases
Population Detergents Pain Hemorrhage Haemophilia Hemophilia A law.invention Pharmacokinetics Randomized controlled trial Von Willebrand factor law hemic and lymphatic diseases medicine Humans Prospective Studies Adverse effect Prospective cohort study education Genetics (clinical) education.field_of_study Factor VIII biology business.industry Hematology General Medicine medicine.disease Regimen Treatment Outcome Anesthesia biology.protein Solvents Virus Inactivation Safety business |
| Zdroj: | Haemophilia : the official journal of the World Federation of Hemophilia. 13(1) |
| ISSN: | 1351-8216 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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