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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) (Leopold II)
The objective of the trial is to demonstrate that 2-3 times per week prophylaxis therapy with BAY81-8973 is superior to on-demand therapy with BAY81-8973 in patients with severe Hemophilia A. The hypothesis is that prophylaxis will result in fewer bleeds than on-demand treatment.
Details
| Lead sponsor | Bayer |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 80 |
| Start date | 2011-01 |
| Completion | 2012-12 |
Conditions
- Hemophilia A
Interventions
- rFVIII (BAY81-8973) on demand
- rFVIII (BAY81-8973) prophylaxis low-dose
- rFVIII (BAY81-8973) prophylaxis high-dose
Primary outcomes
- Annualized Number of All Bleeds — Up to 12 months (6 months per mode of potency assignment according to the randomized cross-over design)
The annualized number of bleeds experienced by participants
Countries
United States, Argentina, China, Colombia, Czechia, India, Indonesia, Japan, Mexico, Romania, Russia, Serbia, Slovakia, South Africa, Taiwan, Thailand, Turkey (Türkiye), Ukraine