Document Detail

In vivo recovery and safety of human factor VIII product AAFACT in patients with haemophilia A.
MedLine Citation:
PMID:  12614366     Owner:  NLM     Status:  MEDLINE    
AAFACT, a monoclonal purified, solvent/detergent treated human plasma-derived coagulation factor VIII concentrate obtained from plasma of voluntary, non-remunerated blood donors, is manufactured and marketed in the Netherlands by Sanquin Plasma Products since 1995. In a postmarketing surveillance study, 70 previously treated haemophilia A patients were included (73% severe, 14% moderate and 13% mild haemophilia A). Most of these patients were followed during 4 years for the appearance of adverse events, possible transmissions of blood-borne viruses and the occurrence of antibodies against FVIII. The efficacy of treatment was determined in each patient by the in vivo recovery of FVIII. During this study, only six adverse events, possibly related to the use of AAFACT, were reported. None of these were indicated as serious. Transmissions of HIV, HAV, HBV and HCV in the seronegative patients have not been observed. In none of the patients, inhibitors to FVIII were detected. The in vivo recovery of FVIII during this study was not different from the in vivo recovery observed in eight patients during the preregistration study. There was a correlation of in vivo recovery with age and body weight. From these results, we conclude that the clinical usage of this human plasma-derived FVIII product is efficient and safe.
P J M Vossebeld; M H Tissing; H M Van Den Berg; F W G Leebeek; A De Goede-Bolder; I R O NovAkovA; W B J Gerrits; M Peters; M M W Koopman; A Faber; H Hiemstra; P Grob; P F W Strengers
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Haemophilia : the official journal of the World Federation of Hemophilia     Volume:  9     ISSN:  1351-8216     ISO Abbreviation:  Haemophilia     Publication Date:  2003 Mar 
Date Detail:
Created Date:  2003-03-04     Completed Date:  2003-05-01     Revised Date:  2009-10-21    
Medline Journal Info:
Nlm Unique ID:  9442916     Medline TA:  Haemophilia     Country:  England    
Other Details:
Languages:  eng     Pagination:  157-63     Citation Subset:  IM    
Sanquin Medical Department, Amsterdam, The Netherlands.
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MeSH Terms
Age Factors
Body Weight
Child, Preschool
Factor VIII / adverse effects,  antagonists & inhibitors,  therapeutic use*
Follow-Up Studies
Hemophilia A / blood,  drug therapy*
Middle Aged
Product Surveillance, Postmarketing
Virus Diseases / prevention & control,  transmission
Virus Inactivation
Reg. No./Substance:
9001-27-8/Factor VIII

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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