Phase 3
Completed N=30
Study Evaluating B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery
Source: ClinicalTrials.gov NCT00243659 ↗Enrolled (actual)
30
Serious AEs
—
Results posted
Jul 2009
Primary outcomePrimary: Number of Patients Who Achieved Hemostatic Efficacy After Surgery — 15; 3; 5; 2 patients
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Who Achieved Hemostatic Efficacy After Surgery |
15; 3; 5; 2; 0; 0 | — |
| SECONDARY Number of Patients Who Achieved Hemostatic Efficacy at Hospital Discharge |
18; 5; 2; 0; 0; 0 | — |
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
Data sourced from ClinicalTrials.gov (NCT00243659). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.