Comparison of pharmacokinetic parameters based on FIX activity
| . | N9-GP . | Previous FIX . | Treatment difference N9-GP/previous FIX ratio (95% CI), P . | ||
|---|---|---|---|---|---|
| N . | Estimate . | N . | Estimate . | ||
| pdFIX | |||||
| IR30, (U/mL)/(U/kg) | 8 | 0.0134 | 8 | 0.0112 | 1.20 (0.97-1.48), 0.083 |
| t[1/2], h | 8 | 92.67 | 8 | 17.79 | 5.21 (3.88-6.99), < .001 |
| CL, mL/h/kg | 8 | 0.71 | 8 | 5.48 | 0.13 (0.12-0.15), < .001 |
| Vz, mL/kg | 8 | 95.22 | 8 | 140.58 | 0.68 (0.49-0.93), 0.018 |
| AUC, U × h/mL* | 8 | 70.20 | 8 | 9.13 | 7.69 (6.92-8.55), < .001 |
| rFIX | |||||
| IR30, (U/mL)/(U/kg) | 7 | 0.0131 | 6 | 0.0068 | 1.94 (1.53-2.47), < .001 |
| t[1/2], h | 7 | 92.76 | 7 | 19.34 | 4.80 (3.50-6.57), < .001 |
| CL, mL/h/kg | 7 | 0.70 | 7 | 6.99 | 0.10 (0.09-0.11), < .001 |
| Vz, mL/kg | 7 | 93.16 | 7 | 194.98 | 0.48 (0.34-0.67), < .001 |
| AUC, U × h/mL* | 7 | 72.47 | 7 | 7.15 | 10.13 (9.04-11.35) < .001 |
| . | N9-GP . | Previous FIX . | Treatment difference N9-GP/previous FIX ratio (95% CI), P . | ||
|---|---|---|---|---|---|
| N . | Estimate . | N . | Estimate . | ||
| pdFIX | |||||
| IR30, (U/mL)/(U/kg) | 8 | 0.0134 | 8 | 0.0112 | 1.20 (0.97-1.48), 0.083 |
| t[1/2], h | 8 | 92.67 | 8 | 17.79 | 5.21 (3.88-6.99), < .001 |
| CL, mL/h/kg | 8 | 0.71 | 8 | 5.48 | 0.13 (0.12-0.15), < .001 |
| Vz, mL/kg | 8 | 95.22 | 8 | 140.58 | 0.68 (0.49-0.93), 0.018 |
| AUC, U × h/mL* | 8 | 70.20 | 8 | 9.13 | 7.69 (6.92-8.55), < .001 |
| rFIX | |||||
| IR30, (U/mL)/(U/kg) | 7 | 0.0131 | 6 | 0.0068 | 1.94 (1.53-2.47), < .001 |
| t[1/2], h | 7 | 92.76 | 7 | 19.34 | 4.80 (3.50-6.57), < .001 |
| CL, mL/h/kg | 7 | 0.70 | 7 | 6.99 | 0.10 (0.09-0.11), < .001 |
| Vz, mL/kg | 7 | 93.16 | 7 | 194.98 | 0.48 (0.34-0.67), < .001 |
| AUC, U × h/mL* | 7 | 72.47 | 7 | 7.15 | 10.13 (9.04-11.35) < .001 |
N indicates number of patients; IR30min, incremental recovery determined as the peak level recorded 30 minutes after administration; t[1/2], plasma half-life; CL, plasma clearance; Vz, volume of distribution; and AUC, area under the plasma activity curve.
AUC is adjusted to a dose of 50 U/kg under the assumption of dose linearity. The estimated means and 95% CI are presented for plasma-derived FIX (pdFIX), recombinant FIX (rFIX), and N9-GP. The treatment difference (ratio: N9-GP/previous FIX) and 95% CI are presented.