Conditions: Hemophilia A
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 82
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Standard prophylaxis arm 2: PK-driven prophylaxis

Interventions: intervention 1: Antihemophilic factor, recombinant, manufactured protein-free intervention 2: Antihemophilic factor, recombinant, manufactured protein-free
Intervention descriptions: intervention 1: Standard prophylaxis: 20-40 IU/kg every 48+/-6 hours, actual dose determined by investigator intervention 2: PK-driven prophylaxis: 20-80 IU/kg every 72+/-6 hours, actual dose determined by Baxter using an algorithm and the patient´s pharmacokinetic data

Protocol document: