Conditions: Hematologic Disease Hemophilia A
Keywords: Coagulation Disorders
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 20
Healthy volunteers: no

Brief summary:
The purpose of the study is to evaluate the effect of prophylactic treatment on the number of joint bleeds and quality of life in severe hemophilia A subjects compared to on-demand treatment in a one-group two-treatment schedule design.

In addition, the effect of prophylactic treatment on the joint function, the number of all bleeds, and on the quality of life compared to on-demand treatment and health-economic data will be assessed.

Detailed description:

Arms:
arm 1: On-demand treatment was to follow the same treatment pattern the subject was using before entering the study. While on prophylactic treatment, all subjects were to be treated at a dose of 20-40 IU/kg, 3 times per week at a stable dose.

Interventions: intervention 1: Kogenate (BAY14-2222)
Intervention descriptions: intervention 1: One group two treatment schedules, first on-demand then switch to prophylaxis

Protocol document: