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Pharmacokinetic stu...
Pharmacokinetic studies on Wilfactin((R)), a von Willebrand factor concentrate with a low factor VIII content treated with three virus-inactivation/removal methods
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Goudemand, J (author)
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Scharrer, I (author)
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- Berntorp, Erik (author)
- Lund University,Lunds universitet,Klinisk koagulationsmedicin, Malmö,Forskargrupper vid Lunds universitet,Clinical Coagulation, Malmö,Lund University Research Groups
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Lee, CA (author)
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Borel-Derlon, A (author)
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Stieltjes, N (author)
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Caron, C (author)
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Scherrmann, JM (author)
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Bridey, F (author)
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Tellier, Z (author)
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Federici, AB (author)
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Mannucci, PM (author)
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(creator_code:org_t)
- Elsevier BV, 2005
- 2005
- English.
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In: Journal of Thrombosis and Haemostasis. - : Elsevier BV. - 1538-7933 .- 1538-7836. ; 3:10, s. 2219-2227
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Abstract
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- Objective: In order to correct the primary von Willebrand factor (VWF) defect and avoid supra-physiologic plasma levels of factor VIII, a pure VWF concentrate almost devoid of FVIII was developed and used in France since 1989. Methods: The pharmacokinetic (PK) profile of the most recent version of this concentrate (Wilfactin (R); LFB, Les Ulis, France), treated with three virus-inactivation/removal methods (solvent/detergent, 35 nm filtration, dry heat treatment), was investigated in 25 patients. Seventeen patients with various types of clinically severe von Willebrand disease (VWD) were included in a crossover, randomized trial carried out in five European centers and comparing Wilfactin (R) with concentrates containing both FVIII and VWF (FVIII/VWF). Eight type 3 VWD patients were included in another trial carried out in six French centers comparing Wilfactin (R) with its previous version (Facteur Willebrand-LFB (R); LFB) that adopted one virus-inactivation method only. Results: For both the measurements evaluated in this study (VWF antigen, VWF:Ag; and VWF ristocetin co-factor activity, VWF:RCo), Wilfactin (R) had a PK profile similar to that of the FVIII/VWF concentrates and of Facteur Willebrand-LFB (R). VWF:RCo and VWF:Ag recoveries were 2.1 +/- 0.3 and 1.8 +/- 0.3 per IU kg(-1) respectively, and the half-lives were 12.4 +/- 1.8 and 15.9 +/- 1.5 h. The FVIII synthesis rate was 5.8 +/- 1.0 IU dL(-1) h(-1), with a half-life of 15.8 +/- 2.4 h. Conclusion: The PK of VWF and FVIII have not been altered by the three virus-inactivation/removal steps during the manufacturing of Wilfactin (R).
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)
Keyword
- Willebrand factor concentrate
- von
- viral safety
- pharmacokinetic
- severe von Willebrand disease
Publication and Content Type
- art (subject category)
- ref (subject category)
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- By the author/editor
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Goudemand, J
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Scharrer, I
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Berntorp, Erik
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Lee, CA
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Borel-Derlon, A
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Stieltjes, N
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show more...
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Caron, C
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Scherrmann, JM
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Bridey, F
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Tellier, Z
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Federici, AB
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Mannucci, PM
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show less...
- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Cardiac and Card ...
- Articles in the publication
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Journal of Throm ...
- By the university
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Lund University