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. 2021 Jan 27;121(10):1326–1336. doi: 10.1055/a-1376-0970

Table 2. Agreements between the washout, 6-sampling time point, and the no-washout, single-clinic visit 2 time-point PK protocols for the PK parameters of clearance and terminal half-life generated using the ADVATE myPKFiT dosing tool and factor VIII:C levels a .

PK parameter One-stage assay Chromogenic assay
ICC (95% CI) ICC (95% CI)
All participants ( n  = 35) Cl (mL/h/kg) 0.73 (0.52, 0.85) 0.54 (0.25, 0.74)
t1/2 (h) 0.84 (0.70, 0.91) 0.80 (0.63, 0.89)
O blood group ( n  = 12) Cl (mL/h/kg) 0.52 (−0.04, 0.84) 0.35 (−0.25, 0.76)
t1/2 (h) 0.37 (−0.23, 0.76) 0.37 (−0.23, 0.77)
Non-O blood group ( n  = 20) Cl (mL/h/kg) 0.83 (0.63, 0.93) 0.50 (0.08, 0.76)
t1/2 (h) 0.93 (0.84, 0.97) 0.85 (0.66, 0.94)

Abbreviations: Cl, clearance; PK, pharmacokinetic; t 1/2 , terminal half-life.

Note: Data for 35/39 subjects were available for analysis: the ADVATE myPKFiT application was unable to generate PK parameters for the 2-point PKs of four subjects (two subjects had doses <10 IU/kg which is outside the allowable range of 10–100 IU/kg for the dosing tool, one subject had technical issues with the FVIII:C samples and one subject did not have adequate documentation of the FVIII infusion prior to the clinic visit for the 2-sampling time point PK study). Blood group status was not available for three subjects.

a

Factor VIII:C determinations done in central laboratory.