rIX-FP | rFIX | |||
---|---|---|---|---|
50 IU/kg (N=46) [ |
75 IU/kg (N=8) [ |
50 IU/kg (N=11) [ |
75 IU/kg (N=17) [ |
|
Half-life (hours) | 101.7 | 104 | 18.1 | 22.5 |
Clearance (mL/h/kg) | 0.769 | 0.84 | 0.84 | 7.5 |
AUC∞ (IU |
7176 | 9345 | 548 | 1070 |
IR (IU/dL)(IU/kg) | 1.27 | 1.08 | 0.84 | 0.80 |
rFIX | rIX-FP | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
ADULT/ADOLESCENTS [ |
ADULT/ADOLESCENTS [ |
PAEDIATRICS [ |
ADULT/ADOLESCENTS [ |
PAEDIATRICS [ |
||||||
Dosing intervals |
3.5 | 7 | 3.5–7 | 7 | 10 | 14 | 21 |
7 | 10 | 14 |
Number of patients (n) | 44 | 25 | 22 | 22 | 17 | 41 | 11 | 21 | 8 | 8 |
Dose (IU/kg) | 50 | 100 |
64.6 | 35–50 | 50–75 | 50–75 | 100 | 25–50 | 50–75 | 50–75 |
Annual infusions (n) |
104 | 52 | 52–104 | 52 | 37 | 26 | 17 | 52 | 37 | 26 |
ABR (median) | 2.6 | 2.0 | 3.7 | 1.33 | 0.80 | 0.92 | 0.32 | 2.00 | 3.50 | 5.60 |
AsBR (median) | 1.7 | 1.0 | 0.58 | 0.00 | 0.28 | 0.37 | 0.00 | 0.00 | 0.00 | 1.10 |
Steady-state trough FIX (%) mean (SD) | 3.57 (3.11) | 2.0 (N/A) | N/A | 22.0 (8.4) | 19.8 (16.0) | 13.6 (6.4) | 7.6 (2.3) | 15.1 (4.1) | 8.8 (5.7) | 7.2 (2.9) |