This study is a 2 year safety/efficacy study of a new formulation of recombinant factor VIII, Kogenate-2. It's manufactured without albumin & has a modified divided purification process which removes any potential contaminants or impurities The study is divided into 3 stages: Stage 1, 48-hr randomized crossover pharmaco kinetic study of Kogenate-2 compared w/Kogenate; Stage 2/3, a 6 month clinical efficacy study in which Kogenate-2 is used to treat """"""""hemorrhages"""""""" & Stage 3 extension which continues the latter for up to 18 more months.

Project Start
1997-12-01
Project End
1998-11-30
Budget Start
1997-10-01
Budget End
1998-09-30
Support Year
37
Fiscal Year
1998
Total Cost
Indirect Cost
Name
University of Pittsburgh
Department
Type
DUNS #
053785812
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213
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