Document Detail

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.
MedLine Citation:
PMID:  15357767     Owner:  NLM     Status:  MEDLINE    
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.
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:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial    
Journal Detail:
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:
Created Date:  2004-09-10     Completed Date:  2005-02-07     Revised Date:  2009-10-21    
Medline Journal Info:
Nlm Unique ID:  9442916     Medline TA:  Haemophilia     Country:  England    
Other Details:
Languages:  eng     Pagination:  428-37     Citation Subset:  IM    
Comprehensive Bleeding Disorders Center, Peoria, IL 61614, USA.
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MeSH Terms
Double-Blind Method
Factor VIII / adverse effects,  pharmacokinetics,  therapeutic use*
Hemophilia A / drug therapy*
Hemorrhage / prevention & control
Hemostasis / drug effects
Middle Aged
Recombinant Proteins
Treatment Outcome
Reg. No./Substance:
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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