Status:
COMPLETED
Study Evaluating B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Hemophilia A
Eligibility:
MALE
12+ years
Phase:
PHASE3
Brief Summary
This study will examine the efficacy and safety of ReFacto AF in patients with severe and moderately severe hemophilia A undergoing elective major surgery when administered by either bolus injections ...
Eligibility Criteria
Inclusion
- Male, at least 12 years old, with severe hemophilia A undergoing major elective major surgery requiring FVIII replacement for at least 6 days. Negative FVIII inhibitor test at screening and no past history of inhibitor.
- Previously treated with at least 150 exposure days to any Factor VIII product
- Normal hepatic and renal function tests and no other bleeding disorder
Exclusion
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00243659
Start Date
April 1 2006
End Date
June 1 2008
Last Update
June 3 2011
Active Locations (17)
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1
La Jolla, California, United States, 92093
2
Detroit, Michigan, United States, 48201
3
Detroit, Michigan, United States, 48202
4
Chapel Hill, North Carolina, United States, 27599