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

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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)

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.


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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