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.
Factor VIII:C determinations done in central laboratory.