Trials / Completed
CompletedNCT00243659
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer · Industry
- Sex
- Male
- Age
- 12 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ReFacto AF |
Timeline
- Start date
- 2006-04-01
- Primary completion
- 2008-06-01
- Completion
- 2008-06-01
- First posted
- 2005-10-24
- Last updated
- 2011-06-03
- Results posted
- 2009-07-20
Locations
17 sites across 8 countries: United States, Australia, Austria, Hungary, New Zealand, Poland, Romania, Sweden
Source: ClinicalTrials.gov record NCT00243659. Inclusion in this directory is not an endorsement.