Study Evaluating B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery
An Open Label Multi-center Study to Assess the Efficacy and Safety of B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery
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 (BI) or continuous infusion (CI).
Number of Patients Who Achieved Hemostatic Efficacy After Surgery
Number of Patients Who Achieved Hemostatic Efficacy at Hospital Discharge
Study Arms / Comparison Groups
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Primary Completion Date
- 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
12 Years - N/A
Accepts Healthy Volunteers
Medical Monitor, ,
Wyeth is now a wholly owned subsidiary of Pfizer
Medical Monitor, Study Director, Wyeth is now a wholly owned subsidiary of Pfizer