Table 1.

Participant disposition, demographics, and baseline clinical characteristics

Characteristic	Cohort 1 (50 IU/kg efanesoctocog alfa)	Cohort 2 (65 IU/kg efanesoctocog alfa)
Enrolled, n	10	14
Included in safety analysis*	10 (100)	14 (100)
Included in pharmacokinetic analysis†	9 (90)	14 (100)
Completed study‡	10 (100)	14 (100)
Age, mean (range), y	35 (25-55)	41 (24-58)
Weight, mean (range), kg	79.3 (51.0-113.0)	95.3 (53.0-130.9)
White race	10 (100)	14 (100)
Ongoing or resolved medical/surgical history §
Hepatic	7 (70)	13 (92.9)
Musculoskeletal	9 (90)	11 (78.6)
Cardiovascular	1 (10)	8 (57.1)
Gastrointestinal	2 (20)	2 (14.3)
Other	0 (0)	2 (14.3)
Time since hemophilia diagnosis, mean (SD), y	34.1 (9.9)	38.8 (9.7)
No. of bleeds in past 12 mo, median (range)	48 (1-65)	48 (3-96)
Prestudy FVIII regimen ¶
On demand	8 (80)	13 (92.9)
Prophylaxis	2 (20)	1 (7.1)

Unless otherwise noted, data are n (%).

SD, standard deviation.

^*The safety analysis included participants who received ≥1 dose of efanesoctocog.

^†The PK analysis included participants who had adequate blood samples for PK assessments, as determined by the sponsor.

^‡Defined as participants who did not discontinue early.

^§Includes conditions present in >10% of participants in either group.

^¶The most recent regimen that the participant was receiving prior to the study.