PK parameters by one-stage clotting (aPTT) assay for rFVIIIFc and rFVIII per dose group
| Parameter . | 25 IU/kg (N = 6) . | 65 IU/kg (N = 9) . | ||||
|---|---|---|---|---|---|---|
| rFVIII geometric mean (95% CI) . | rFVIIIFc geometric mean (95% CI) . | Geometric mean ratio (95% CI) . | rFVIII geometric mean (95% CI) . | rFVIIIFc geometric mean (95% CI) . | Geometric mean ratio (95% CI) . | |
| Cmax, IU/dL | 63.6 (59.1-68.3) | 60.5 (53.1-69.0) | 0.952 (0.819-1.11) | 133 (105-168) | 119 (103-136) | 0.895 (0.795-1.01) |
| P | .440 | .061 | ||||
| AUCINF, h × IU/dL | 994 (723-1370) | 1480 (1160-1880) | 1.48 (1.26-1.76) | 1800 (1350-2400) | 2800 (1980-3970) | 1.56 (1.33-1.83) |
| P | .002 | < .001 | ||||
| t1/2, h | 12.2 (9.14-16.3) | 18.8 (14.8-23.8) | 1.54 (1.40-1.69) | 11.0 (8.76-13.9) | 18.8 (14.3-24.5) | 1.70 (1.54-1.89) |
| P | < .001 | < .001 | ||||
| MRT, h | 17.5 (13.1-23.4) | 27.0 (21.3-34.2) | 1.54 (1.40-1.69) | 15.8 (12.6-19.9) | 27.0 (20.6-35.3) | 1.71 (1.54-1.89) |
| P | < .001 | < .001 | ||||
| CL, mL/h/kg | 2.49 (1.80-3.45) | 1.68 (1.31-2.15) | 0.673 (0.569-0.796) | 3.61 (2.71-4.83) | 2.32 (1.64-3.29) | 0.642 (0.547-0.753) |
| P | .002 | < .001 | ||||
| Vss, mL/kg | 43.9 (39.3-49.0) | 45.4 (39.3-52.5) | 1.04 (0.947-1.13) | 57.4 (48.3-68.3) | 62.8 (55.2-71.5) | 1.09 (0.976-1.22) |
| P | .357 | .107 | ||||
| Incremental recovery, IU/dL per IU/kg | 2.56 (2.36-2.78) | 2.44 (2.12-2.81) | 0.952 (0.819-1.11) | 2.04 (1.61-2.59) | 1.83 (1.59-2.10) | 0.894 (0.795-1.01) |
| P | .444 | .060 | ||||
| Parameter . | 25 IU/kg (N = 6) . | 65 IU/kg (N = 9) . | ||||
|---|---|---|---|---|---|---|
| rFVIII geometric mean (95% CI) . | rFVIIIFc geometric mean (95% CI) . | Geometric mean ratio (95% CI) . | rFVIII geometric mean (95% CI) . | rFVIIIFc geometric mean (95% CI) . | Geometric mean ratio (95% CI) . | |
| Cmax, IU/dL | 63.6 (59.1-68.3) | 60.5 (53.1-69.0) | 0.952 (0.819-1.11) | 133 (105-168) | 119 (103-136) | 0.895 (0.795-1.01) |
| P | .440 | .061 | ||||
| AUCINF, h × IU/dL | 994 (723-1370) | 1480 (1160-1880) | 1.48 (1.26-1.76) | 1800 (1350-2400) | 2800 (1980-3970) | 1.56 (1.33-1.83) |
| P | .002 | < .001 | ||||
| t1/2, h | 12.2 (9.14-16.3) | 18.8 (14.8-23.8) | 1.54 (1.40-1.69) | 11.0 (8.76-13.9) | 18.8 (14.3-24.5) | 1.70 (1.54-1.89) |
| P | < .001 | < .001 | ||||
| MRT, h | 17.5 (13.1-23.4) | 27.0 (21.3-34.2) | 1.54 (1.40-1.69) | 15.8 (12.6-19.9) | 27.0 (20.6-35.3) | 1.71 (1.54-1.89) |
| P | < .001 | < .001 | ||||
| CL, mL/h/kg | 2.49 (1.80-3.45) | 1.68 (1.31-2.15) | 0.673 (0.569-0.796) | 3.61 (2.71-4.83) | 2.32 (1.64-3.29) | 0.642 (0.547-0.753) |
| P | .002 | < .001 | ||||
| Vss, mL/kg | 43.9 (39.3-49.0) | 45.4 (39.3-52.5) | 1.04 (0.947-1.13) | 57.4 (48.3-68.3) | 62.8 (55.2-71.5) | 1.09 (0.976-1.22) |
| P | .357 | .107 | ||||
| Incremental recovery, IU/dL per IU/kg | 2.56 (2.36-2.78) | 2.44 (2.12-2.81) | 0.952 (0.819-1.11) | 2.04 (1.61-2.59) | 1.83 (1.59-2.10) | 0.894 (0.795-1.01) |
| P | .444 | .060 | ||||
Estimated means, 95% CI for means, and mean differences were transformed to obtain estimated geometric means, 95% CI for geometric means, and geometric mean ratios, respectively.
CI indicates confidence interval.