In this open multicenter study the safety and efficacy of recombinant factor VIII (rFVIII) was assessed in 39 previously treated @entity1 with @entity447 (factor VIII basal activity < or = 15%). Recombinant @entity2801 was administered for prophylaxis and treatment of @entity548 episodes and for surgical procedures. A total of 3679 infusions of rFVIII were given. Efficacy of rFVIII as assessed by subjective evaluation of response to infusion and mean annual consumption of rFVIII was comparable to that of plasma derived @entity2801 concentrates. The incremental recovery of @entity2801 (2.4 +/- 0.83%/IU/kg, 2.12 +/- 0.61%/IU/kg, resp.) was within the expected range. No clinical significant @entity2801 inhibitor was detected in this trial. Five of 16 susceptible @entity1 showed a seroconversion for @entity8344 . However, the results are ambiguous in two cases and might be explained otherwise in one further case. Thus, in two @entity1 a reliable seroconversion for @entity8344 was observed.

A multicenter pharmacosurveillance study for the evaluation of the efficacy and safety of recombinant factor VIII in the treatment of @entity1 with XXXX . German Kogenate Study Group.

@entity1 :: ('9606', 'Species') :: ['patients'] @entity2801 :: ('2157', 'Gene') :: ['FVIII'] @entity548 :: ('MESH:D006470', 'Disease') :: ['bleeding'] @entity447 :: ('MESH:D006467', 'Disease') :: ['hemophilia A'] @entity8344 :: ('10798', 'Species') :: ['parvovirus B19']
@entity447 :: (MESH:D006467,Disease) :: ['hemophilia A']
