Conditions: Hemophilia A With Inhibitors
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 34
Healthy volunteers: no

Brief summary:
The objective of this study is to assess whether prophylactic therapy with an activated prothrombin complex concentrate (FEIBA)will result in a significant reduction in the number of bleeds in patients with hemophilia and persistent high responding inhibitors.

Detailed description:

Arms:
arm 1: Patients receive 6 months of on-demand therapy with study drug followed by 6 months of prophylaxis therapy with study drug arm 2: Patients receive 6 months of prophylaxis therapy with study drug followed by 6 months on-demand therapy with study drug

Interventions: intervention 1: activated prothrombin complex concentrate (FEIBA)
Intervention descriptions: intervention 1: FEIBA for prophylaxis therapy dosed at 85 U/Kg +/- 15% on three non-consecutive days each week for 6 months

FEIBA for on-demand therapy dosed at 85 U/Kg +/- 15% for bleeding episodes for 6 months

Protocol document: