A phase II/III, randomized, cross-over, open-label trial to demonstrate superiority of prophylaxis over on-demand therapy in previously treated subjects with severe hemophilia A treated with plasma protein-free recombinant FVIII formulated with sucrose (BAY 81-8973)
- Registry ID
- EUCTR2009-012150-20
- Source registry
- EUCTR
- Status
- Completed
- Phase
- PHASE3
- Sponsor
- Bayer HealthCare AG
- Start date
- 2011-02-02
- Completion date
- 2012-12-05
- Last update
- 2026-08-16
Conditions
- Severe Hemophilia-A (< 1% FVIII:C)
Summary
To demonstrate the superiority of prophylaxis over on demand therapy by a clinically significant decrease in bleeding rate following 12 months of treatment with BAY 81-8973.
Locations
View on source registry