A Trial to Compare Prophylaxis Therapy to On-demand Therapy With a New Full Length Recombinant FVIII in Patients With Severe Hemophilia A
Phase 3
Completed
- Conditions
- Hemophilia A
- Registration Number
- NCT01233258
- Lead Sponsor
- Bayer
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 80
Inclusion Criteria
- Male, aged 12 to 65 years
- Severe hemophilia A
- History of more than 150 exposure days (ED) with clotting factor concentrates
- Currently receiving episodic treatment with FVIII; no regular prophylaxis for more than 6 consecutive months in the past 5 years
- No current Factor VIII inhibitor or history of inhibitor
- Willing to use electronic patient diary
Exclusion Criteria
- Presence of another bleeding disease that is different from hemophilia A
- Thrombocytopenia
- Abnormal renal function
- Presence of active liver disease
- Known hypersensitivity to FVIII
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method Annualized Number of All Bleeds During CS/ADJ Period Up to 6 months (6 months on CS/ADJ potency assignment) The annualized number of bleeds experienced by participants while they were taking rFVIII (BAY81-8973) assayed by CS/ADJ
Percentage of Bleeds Per Participant Controlled With ≤ 2 Injections in Participants Treated on Demand With rFVIII (BAY81-8973) Up to 12 months (6 months per mode of potency assignment according to the randomized cross-over design) The percentage of bleeds per participant on on-demand treatment that stopped after two or fewer injections
Annualized Number of All Bleeds During CS/EP Period Up to 6 months (6 months on CS/EP potency assignment) The annualized number of bleeds experienced by participants while they were taking rFVIII (BAY81-8973) assayed by CS/EP