Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00243659 | Study Evaluating B-Domain Deleted Recombinant Factor VIII (BDDrFVIII, ReFacto AF) in Patients With Hemophilia A Undergoing Elective Major Surgery | PHASE3 | COMPLETED | 30 | — | — | Apr 1, 2006 | Jun 1, 2008 | Jun 3, 2011 | 17 | United States, Australia +6 |
| NCT00141843 | Study to Establish Bioequivalence of ReFacto AF (BDDrFVIII) With Advate (FLrFVIII) in Hemophilia A | PHASE3 | COMPLETED | 100 | — | — | Jul 1, 2005 | Nov 1, 2006 | Apr 22, 2008 | 41 | United States, Australia +11 |
| NCT00037544 | Study Evaluating ReFacto AF in Severe Hemophilia A | PHASE3 | COMPLETED | - | — | — | - | Aug 1, 2004 | Apr 22, 2008 | - | — |
| NCT00038935 | Study Evaluating BDDRFVIII and ReFacto AF in Hemophilia A | PHASE3 | COMPLETED | - | — | — | - | Feb 1, 2003 | Apr 22, 2008 | - | — |
Efficacy at the end of surgery as determined by the investigator and/or the surgeon using the 4 point ordinal scale (Excellent, Good, Moderate or None). Excellent: Achieved hemostatic comparable to non-hemophilic patients. Good: Prolonged time to hemostasis (with somewhat increased bleeding compared to non-hemophilic patients.
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | - |
| B | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| ReFacto AF | BIOLOGICAL | - |
| B-Domain deleted Recombinant Factor VIII | GENETIC | - |
| BDDrFVIII | GENETIC | - |
* 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 produc...