A Trial to Compare Prophylaxis Therapy to On-demand Therapy With a New Full Length Recombinant FVIII in Patients With Severe Hemophilia A (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.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)
Enrollment: 80
Study Start Date: January 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

Arms:
- Experimental: Arm 1: rFVIII on demand first CS/EP then CS/ADJ
- Experimental: Arm 2: rFVIII on demand first CS/ADJ then CS/EP
- Experimental: Arm 3: rFVIII prophylaxis low-dose first CS/EP then CS/ADJ
- Experimental: Arm 4: rFVIII prophylaxis low-dose first CS/ADJ then CS/EP
- Experimental: Arm 5: rFVIII prophylaxis high-dose first CS/EP then CS/ADJ
- Experimental: Arm 6: rFVIII prophylaxis high-dose first CS/ADJ then CS/EP