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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00543439 | Study Evaluating Prophylaxis Treatment & Characterizing Efficacy, Safety, & PK Of B-Domain Deleted Recombinant FVIII | PHASE3 | COMPLETED | 66 | — | — | Dec 1, 2007 | Apr 1, 2018 | Jan 11, 2019 | 28 | United States, Argentina +11 |
| NCT01579903 | Relative Bioavailability Of Two Formulations Of Moroctocog Alfa (AF-CC) | PHASE1 | COMPLETED | 16 | — | — | Aug 1, 2012 | Jan 1, 2013 | Feb 8, 2013 | 3 | Bulgaria, Hungary +1 |
ABR for each participant was calculated as the number of bleeds requiring administration of moroctocog alfa (AF-CC) divided by the total therapy duration (in days), then multiplied by 365.25 (days in a year).
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | On-Demand therapy for 6 months, followed by Routine Prophylaxis treatment for 1 year. |
| 2 | EXPERIMENTAL | Routine Prophylaxis Crossover |
| Sequence 1 | EXPERIMENTAL | Subjects randomized to receive Treatment A during Period 1, then Treatment B during Period 2. |
| Sequence 2 | EXPERIMENTAL | Subjects randomized to receive Treatment B during Period 1, then Treatment B during Period 2. |
| Name | Type | Description |
|---|---|---|
| Moroctocog alfa (AF-CC) | BIOLOGICAL | On-demand therapy for 6 months, followed by routine prophylaxis 25 IU/kg, administered every other day for 1 year. |
Inclusion Criteria: * Male subjects, aged less than 6 years, with moderately severe to severe hemophilia A. * A negative FVIII inhibitor titer at screening, and a medical history negative for a past FVIII inhibitor. * At least 20 exposure days to any FVIII replacement product. * Adequate hepatic an...