Patient disposition
| . | rIX-FP . | pdFIX or rFIX . | Total n (%) . | ||
|---|---|---|---|---|---|
| 25 IU/kg n (%) . | 50 IU/kg n (%) . | 75 IU/kg n (%) . | 50 IU/kg n (%) . | ||
| Patients enrolled | 9 | 14 | 9 | 15 | 25 |
| Analysis populations | |||||
| Safety population | 9 (100.0) | 14 (100.0) | 9 (100.0) | 15 (100.0) | 25 (100.0) |
| PK population | 7 (77.8) | 13 (92.9) | 8 (88.9) | 12 (80.0) | 22 (88.0) |
| Completed study | 9 (100.0) | 14 (100.0) | 9 (100.0) | 15 (100.0) | 25 (100.0) |
| . | rIX-FP . | pdFIX or rFIX . | Total n (%) . | ||
|---|---|---|---|---|---|
| 25 IU/kg n (%) . | 50 IU/kg n (%) . | 75 IU/kg n (%) . | 50 IU/kg n (%) . | ||
| Patients enrolled | 9 | 14 | 9 | 15 | 25 |
| Analysis populations | |||||
| Safety population | 9 (100.0) | 14 (100.0) | 9 (100.0) | 15 (100.0) | 25 (100.0) |
| PK population | 7 (77.8) | 13 (92.9) | 8 (88.9) | 12 (80.0) | 22 (88.0) |
| Completed study | 9 (100.0) | 14 (100.0) | 9 (100.0) | 15 (100.0) | 25 (100.0) |
Patients were permitted to participate in up to 2 rIX-FP dosing cohorts, and a wash-out period of at least 14 days between doses was required. Seven subjects participated in more than 1 arm as follows: 3 subjects participated in the 25-IU/kg and 50-IU/kg arms, 3 subjects participated in the 50-IU/kg and 75-IU/kg arms, and 1 subject participated in the 25-IU/kg and 75-IU/kg arms. The safety population included all subjects exposed to rIX-FP. Subjects were included in the PK analysis if they had more than 1 postdose PK sample drawn with no sample quality issues as reported by the central laboratory and who did not receive any FIX product for the treatment of a bleed during the PK sampling period.