Status:
COMPLETED
Prophylaxis Versus On-demand Therapy Through Economic Report
Lead Sponsor:
Bayer
Conditions:
Hemophilia A
Eligibility:
All Genders
12-55 years
Brief Summary
The project is a controlled observational, multicenter, prospective data collection on secondary prophylaxis with Kogenate Bayer in adolescents and adults with severe haemophilia A (FVIII \< 1%). The...
Eligibility Criteria
Inclusion
- age ≥ 12 years and ≤ 55 years
- severe haemophilia A (FVIII \< 1%)
- absence of inhibitors (Bethesda titre \< 0.6 BU/ml)
- Previous Treated Patients (prior exposure days \> 200)
- Kogenate Bayer administered 20-30 IU/kg -3 times a week, for the prophylaxis group
- ≥ 6 joint bleeds requiring treatment with FVIII concentrates in the previous 6 months before enrollment, for on-demand group
- written informed consent
Exclusion
- concomitant severe and chronic diseases or congenital skeletal malformation
- unreliability of patient or likelihood of follow-up failure
- presence of inhibitors or history of inhibitors (in the previous 2 years)
- currently on immune tolerance treatment
- hepatic cirrhosis or liver disease in rapid progression
- AIDS
- platelet count \< 75,000/mm3
- presence of conditions that influence negatively patient´s compliance
- participation in another study
Key Trial Info
Start Date :
July 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT01159587
Start Date
July 1 2004
End Date
December 1 2010
Last Update
April 13 2011
Active Locations (1)
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1
Many Locations, Italy