Status:
COMPLETED
Study Evaluating ReFacto® in Hemophilia A Undergoing Major Surgery
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Hemophilia A
Eligibility:
MALE
6+ years
Phase:
PHASE4
Brief Summary
The primary objective of this clinical research study is to evaluate the safety and efficacy of ReFacto in subjects with hemophilia A undergoing major surgery monitored using the chromogenic substrate...
Eligibility Criteria
Inclusion
- Age ≥ 6 years
- Male previously treated patients (≥150 Exposure Days) with moderate or severe hemophilia A (i.e. ≤ 5% FVIII:C) who will undergo elective major surgery that is anticipated to require at least 6 consecutive days of daily factor VIII (FVIII) infusions (surgical and post-surgical prophylaxis)
- Ability to adhere to the protocol requirements
Exclusion
- Hypersensitivity to ReFacto, murine allergen, or hamster allergen 2 History of FVIII inhibitor or current inhibitor, defined as \> 0.6 BU
- Prior participation in this study
- Any concomitant bleeding disorder other than hemophilia A
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2007
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00092976
Start Date
February 1 2003
End Date
July 1 2007
Last Update
December 28 2007
Active Locations (4)
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1
Los Angeles, California, United States, 90007
2
New Brunswick, New Jersey, United States, 08903-0019
3
Cincinnati, Ohio, United States, 45229
4
Hershey, Pennsylvania, United States, 17033