Status:
COMPLETED
A Trial to Compare Prophylaxis Therapy to On-demand Therapy With a New Full Length Recombinant FVIII in Patients With Severe Hemophilia A
Lead Sponsor:
Bayer
Conditions:
Hemophilia A
Eligibility:
MALE
12-65 years
Phase:
PHASE3
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 hypo...
Eligibility Criteria
Inclusion
- 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
- Presence of another bleeding disease that is different from hemophilia A
- Thrombocytopenia
- Abnormal renal function
- Presence of active liver disease
- Known hypersensitivity to FVIII
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01233258
Start Date
January 1 2011
End Date
December 1 2012
Last Update
November 28 2016
Active Locations (47)
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1
Dayton, Ohio, United States, 45404
2
Houston, Texas, United States, 77030
3
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1221ADC
4
Corrientes, Corrientes Province, Argentina, W3410AVV