BAY14-2222 Prophylaxis and Joint Function Improvement (Adults)

A Prospective Controlled Study on the Effect on Bleeding Events and Joint Function in Young Adults With Severe Hemophilia A After a 6 Month Prophylaxis Treatment Compared to on Demand Treatment

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.

Inclusion Criteria:

• Severe hemophilia A (< 1% FVIII)
• 30-45 years of age
• Previously treated subject (> 100 Exposure days to any FVIII)
• On-demand therapy with any FVIII

Exclusion Criteria:

• No history of inhibitor
• No planned elective orthopedic surgery during the study duration (13 months)
• No severe concomitant disease
• No history of anaphylactic or other severe reaction to previous FVIII treatment