Baseline-corrected FIX activity and antigen in plasma after a single dose of rIX-FP and previous FIX product
| . | rIX-FP . | Previous FIX . | |||
|---|---|---|---|---|---|
| 25 IU/kg (n = 7) . | 50 IU/kg (n = 13) . | 75 IU/kg (n = 8) . | rFIX: 50 IU/kg (n = 8) . | pdFIX: 50 IU/kg (n = 4) . | |
| 30 min | |||||
| FIX activity | 40.70 (5.58) | 67.31 (13.72) | 81.91 (14.20) | 47.26 (11.90) | 54.80 (9.89) |
| FIX antigen | 36.93 (7.66) | 69.15 (34.59) | 99.23 (22.53) | 35.68 (22.69) | 53.62 (40.58) |
| 48 h | |||||
| FIX activity | 25.67 (7.24) | 37.62 (8.17) | 45.81 (8.34) | 5.96 (1.07) | 5.45 (1.61) |
| FIX antigen | 29.40 (15.76) | 25.63 (17.00) | 44.54 (12.30) | 3.41 (3.08) | 7.35 (9.11) |
| 168 h | |||||
| FIX activity | 7.41 (3.87) | 13.41 (2.91) | 17.39 (4.46) | — | — |
| FIX antigen | 8.98 (4.49) | 9.56 (5.73) | 14.02 (7.26) | — | — |
| 336 h | |||||
| FIX activity | 2.50 (2.66) | 5.54 (2.00) | 6.01 (2.45) | — | — |
| FIX antigen | 2.63 (2.29) | 4.61 (2.96) | 7.80 (4.41) | — | — |
| . | rIX-FP . | Previous FIX . | |||
|---|---|---|---|---|---|
| 25 IU/kg (n = 7) . | 50 IU/kg (n = 13) . | 75 IU/kg (n = 8) . | rFIX: 50 IU/kg (n = 8) . | pdFIX: 50 IU/kg (n = 4) . | |
| 30 min | |||||
| FIX activity | 40.70 (5.58) | 67.31 (13.72) | 81.91 (14.20) | 47.26 (11.90) | 54.80 (9.89) |
| FIX antigen | 36.93 (7.66) | 69.15 (34.59) | 99.23 (22.53) | 35.68 (22.69) | 53.62 (40.58) |
| 48 h | |||||
| FIX activity | 25.67 (7.24) | 37.62 (8.17) | 45.81 (8.34) | 5.96 (1.07) | 5.45 (1.61) |
| FIX antigen | 29.40 (15.76) | 25.63 (17.00) | 44.54 (12.30) | 3.41 (3.08) | 7.35 (9.11) |
| 168 h | |||||
| FIX activity | 7.41 (3.87) | 13.41 (2.91) | 17.39 (4.46) | — | — |
| FIX antigen | 8.98 (4.49) | 9.56 (5.73) | 14.02 (7.26) | — | — |
| 336 h | |||||
| FIX activity | 2.50 (2.66) | 5.54 (2.00) | 6.01 (2.45) | — | — |
| FIX antigen | 2.63 (2.29) | 4.61 (2.96) | 7.80 (4.41) | — | — |
— indicates not applicable.
Mean (SD) plasma FIX activity levels and FIX antigen levels at defined time points after a single dose of rIX-FP. Mean plasma FIX activity levels and FIX antigen levels at defined time points are also presented for previous FIX products (50 IU/kg rFIX or pdFIX).