Hemophilia Adult Prophylaxis Study: Factor VIII in Severe Hemophilia A

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.

Timeline

Start

2012-07

Primary completion

2013-11

Completion

2013-11

Drugs

Indications