| Clinical evaluation of an advanced category antihaemophilic factor prepared using a plasma/albumin-free method: pharmacokinetics, efficacy, and safety in previously treated patients with haemophilia A. | |
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MedLine Citation:
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PMID: 15357767 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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The efficacy and safety of an advanced category recombinant antihaemophilic factor produced by a plasma- and albumin-free method (rAHF-PFM) was studied in 111 previously treated subjects with haemophilia A. The study comprised a randomized, double-blinded, crossover pharmacokinetic comparison of rAHF-PFM and RECOMBINATE rAHF (R-FVIII); prophylaxis (three to four times per week with 25-40 IU kg(-1) rAHF-PFM) for at least 75 exposure days; and treatment of episodic haemorrhagic events. Median age was 18 years, 96% of subjects had baseline factor VIII <1%, and 108 received study drug. Bioequivalence, based on area under the plasma concentration vs. time curve and adjusted in vivo recovery, was demonstrated for rAHF-PFM and R-FVIII. Mean (+/-SD) half-life for rAHF-PFM was 12.0 +/- 4.3 h. Among 510 bleeding events, 473 (93%) were managed with one or two infusions of rAHF-PFM and 439 (86%) had efficacy ratings of excellent or good. Subjects who were less adherent to the prophylactic regimen had a higher bleeding rate (9.9 episodes subject(-1) year(-1)) than subjects who were more adherent (4.4 episodes subject(-1) year(-1); P < 0.03). One subject developed a low titre, non-persistent inhibitor (2.0 BU) after 26 exposure days. These data demonstrate that rAHF-PFM is bioequivalent to R-FVIII, and suggest that rAHF-PFM is efficacious and safe, without increased immunogenicity, for the treatment of haemophilia A. |
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Authors:
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M D Tarantino; P W Collins; C R M Hay; A D Shapiro; R A Gruppo; E Berntorp; G L Bray; S A Tonetta; P C Schroth; A D Retzios; S S Rogy; M G Sensel; B M Ewenstein; |
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Publication Detail:
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Type: Clinical Trial; Journal Article; Randomized Controlled Trial |
Journal Detail:
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Title: Haemophilia : the official journal of the World Federation of Hemophilia Volume: 10 ISSN: 1351-8216 ISO Abbreviation: Haemophilia Publication Date: 2004 Sep |
Date Detail:
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Created Date: 2004-09-10 Completed Date: 2005-02-07 Revised Date: 2009-10-21 |
Medline Journal Info:
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Nlm Unique ID: 9442916 Medline TA: Haemophilia Country: England |
Other Details:
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Languages: eng Pagination: 428-37 Citation Subset: IM |
Affiliation:
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Comprehensive Bleeding Disorders Center, Peoria, IL 61614, USA. mdtara@hemophilia-ctr-peoria.com |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adolescent Adult Aged Child Double-Blind Method Factor VIII / adverse effects, pharmacokinetics, therapeutic use* Hemophilia A / drug therapy* Hemorrhage / prevention & control Hemostasis / drug effects Humans Middle Aged Recombinant Proteins Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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0/F8 protein, human; 0/Recombinant Proteins; 9001-27-8/Factor VIII |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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