Prophylaxis Study of Recombinant Factor VIII Manufactured Protein-Free (rAHF-PFM) in Patients With Hemophilia A
Status:
Completed
Trial end date:
2010-06-16
Target enrollment:
Participant gender:
Summary
The primary purpose of this randomized, two-arm parallel clinical study in 66 previously
treated patients with severe or moderately severe hemophilia A is to compare the rate of
bleeding episodes for standard prophylaxis (20-40 IU/kg every 48 ± 6 hours; actual dose
determined by the investigator) with that of alternate prophylaxis (20-80 IU/kg every 72 + 6
hours; actual dose determined by Baxter utilizing an algorithm and the patient's
pharmacokinetic data). The rates of bleeding episodes for the on-demand regimen and the
prophylaxis regimens will also be compared for the cross-over portion of the study. Enrolled
patients will be treated originally on demand for a period of 6 months and then they will be
randomized into one of the prophylaxis arms. Prophylactic treatment will last for a period of
12 months +/- 2 weeks.