BAY14-2222 Prophylaxis and Joint Function Improvement (Adults)

• Status: Completed
• Trial end date: 2008-03-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Factor VIII

Criteria

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