       Document 0469
 DOCN  M9630469
 TI    Approaching the ideal: therapeutic requirements for factor VIII
       concentrates.
 DT    9603
 AU    Vermylen J; Centre of Molecular and Vascular Biology, Campus
       Gasthuisberg,; Leuven, Belgium.
 SO    Blood Coagul Fibrinolysis. 1995 Jul;6 Suppl 2:S36-9. Unique Identifier :
       AIDSLINE MED/96076197
 AB    The requirements that a factor VIII concentrate should fulfil, as
       adopted by the Belgian Health Council, are reviewed. Lack of
       immunogenicity is an important issue; the Belgian experience suggests
       that a prospective randomized trial allows rather rapid detection of
       grossly increased immunogenicity. An alternative is provided by
       prospective cohort studies, using a uniform protocol to evaluate the
       behavior of each product, and an independent data monitoring centre.
       Residual infectivity is illustrated by an outbreak of hepatitis A in
       heavily treated patients. A prospective randomized trial in Belgium is
       planned to evaluate the benefits and risks of a double-virus inactivated
       product.
 DE    Belgium/EPIDEMIOLOGY  Factor VIII/IMMUNOLOGY/*STANDARDS  Hepatitis
       A/EPIDEMIOLOGY/IMMUNOLOGY  Hepatitis Antibodies/*BLOOD  Human  HIV
       Antibodies/*BLOOD  Prospective Studies  Randomized Controlled Trials
       Risk Factors  JOURNAL ARTICLE

       SOURCE: National Library of Medicine.  NOTICE: This material may be
       protected by Copyright Law (Title 17, U.S.Code).

