Hemophilia Adult Prophylaxis Study: Factor VIII in Severe Hemophilia A
Status:
Terminated
Trial end date:
2013-11-01
Target enrollment:
Participant gender:
Summary
The purpose of this pilot R34 trial is to determine the feasibility of a large single dose
Phase III study of hemophilia adult prophylaxis comparing once weekly with thrice-weekly
recombinant factor VIII. Efficacy will measured by bleeding frequency, factor usage, joint
range of motion, cost, quality-of-life, F.VIII level, and inter-dose hypocoagulability by
thrombin generation. Safety will be measured by inhibitor formation and bleeding events
unresponsive to up to two rescue doses.