Table 4.

Optimal posology results—Children and Infant group results at 10% target trough level.

Parameter	rIX-FP	rFIX	rFIXFc
Children group (6–11 years)*
Steady-state FIX trough levels, IU/dL  Median (IQR)	10.0 (8.1–10.1)	2.0 (1.1–3.4)	4.3 (3.4–5.4)
Patients below target, %	40.6	99.2	99.5
Dose, IU/kg/ week  Median (IQR)	46.0 (35.5–50.0)	182.0 (182.0–182.0)	100.0 (100.0–100.0)
Patients among dose-intervals, %	7d: 100.0	3d: 99.9	7d: 100.0
		3.5d: 0.1
		4d: 0.0
Ratio between FIX product weekly dose (IU/kg) and rIX-FP  Median (IQR)	-	4.0 (3.6–5.1)	2.2 (2.0–2.8)
Infant group (0–5 years)*
Steady-state FIX trough levels, IU/dL  Median (IQR)	6.8 (4.6–9.6)	1.9 (1.0–3.3)	3.5 (2.7–4.3)
Patients below target, %	77.3	99.2	100.0
Dose, IU/kg/week  Median (IQR)	50.0 (50.0–50.0)	238.0 (238.0–238.0)	100.0 (100.0–100.0)
Patients among dose-intervals, %	7d: 100.0	3d: 99.8	7d: 100.0
		3.5d: 0.2
		4d: 0.0
		5d: 0.0
		6d: 0.0
		7d: 0.0
Ratio between FIX product weekly dose (IU/kg) and rIX-FP  Median (IQR)	-	4.8 (4.8–4.8)	2.0 (2.0–2.0)

*At the time of the study, N9-GP was not approved for use in patients less than 12 years old, therefore N9-GP model simulations were not generated for children (6–11 years) or infant (0–5 years) groups.

d, days; FIX, factor IX; IQR, interquartile range; IU, international unit.