Table 1.

Demographics and Baseline Characteristics (ITT Set)

Parameter	Total, N = 13
Age, mean ± SD (years)	3.80 ± 1.76
Body weight, mean ± SD (kg)	18.12 ± 4.44
FIX treatment prior to enrollment, n (%)
Purified FIX concentrate (IMMUNINE®)	13 (100)
Other high-purity plasma-derived FIX	6 (46.15)
Number of FIX EDs prior to enrollment,a n (%)
0 days	0 (0)
1–20 days	2 (15.38)
21–50 days	2 (15.38)
51–150 days	2 (15.38)
>150 days	7 (53.85)
FIX level (%) at enrollment,b mean ± SD	1.92 ± 1.57

Notes: ^aNo patients reported signs of proteinuria. ^bA value <1% was recorded as 1% in 7 patients.

Abbreviations: ED, exposure day; FIX, factor IX; ITT, intent to treat; SD, standard deviation.