A Trial to Compare Prophylaxis Therapy to On-demand Therapy With a New Full Length Recombinant FVIII in Patients With Severe Hemophilia A
| Status: | Completed |
|---|---|
| Conditions: | Anemia, Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 12 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | January 2011 |
| End Date: | December 2012 |
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)
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.
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.
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
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