Brief Title
Study Evaluating B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery
Official Title
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
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 (BI) or continuous infusion (CI).
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Number of Patients Who Achieved Hemostatic Efficacy After Surgery
Secondary Outcome
Number of Patients Who Achieved Hemostatic Efficacy at Hospital Discharge
Condition
Hemophilia A
Intervention
ReFacto AF
Study Arms / Comparison Groups
A
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
30
Start Date
April 2006
Completion Date
June 2008
Primary Completion Date
June 2008
Eligibility Criteria
- 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
Gender
Male
Ages
12 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Medical Monitor, ,
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT00243659
Organization ID
3082B2-311
Study Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Study Sponsor
Medical Monitor, Study Director, Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date
June 2011