Summary of pharmacokinetic analysis in 11 patients with type 3 von Willebrand disease
| Parameter . | Plasma VWF:RCof . | Plasma FVIII:C . | Plasma VWF:Ag . | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Mean ± SD . | Mean ± SD . | Mean ± SD . | |||||||
| A-SD . | A-SD/HT . | P . | A-SD . | A-SD/HT . | P . | A-SD . | A-SD/HT . | P . | |
| AUCINF | 1295 ± 568 | 1403 ± 918 | .82 | 4995 ± 1843 | 5054 ± 1600 | .95 | 3972 ± 988 | 4369 ± 1442 | .42 |
| CL | 0.05 ± 0.025 | 0.06 ± 0.028 | .84 | 0.01 ± 0.005 | 0.01 ± 0.004 | .78 | 0.02 ± 0.004 | 0.02 ± 0.005 | .63 |
| Vss | 0.50 ± 0.139 | 0.51 ± 0.269 | .92 | 0.38 ± 0.095 | 0.43 ± 0.115 | .32 | 0.28 ± 0.052 | 0.27 ± 0.086 | .97 |
| T1/2 | 7.1 ± 2.89 | 6.5 ± 2.41 | .65 | 20.9 ± 6.68 | 23.8 ± 6.15 | .23 | 12.4 ± 2.13 | 12.9 ± 2.06 | .60 |
| Cmax | 152 ± 44.4 | 180 ± 85.8 | .37 | 192 ± 40.9 | 175 ± 56.3 | .35 | 272 ± 67.2 | 281 ± 96.5 | .90 |
| Tmax | 0.39 ± 0.30 | 0.32 ± 0.23 | .30 | 0.3 ± 0.2 | 0.4 ± 0.3 | .30 | 0.32 ± 0.23 | 0.32 ± 0.23 | .90 |
| Incremental in vivo recovery | 2.5 ± 0.7 | 2.9 ± 1.3 | .32 | 2.04 ± 0.38 | 2.11 ± 0.44 | .58 | ND | ND | — |
| Parameter . | Plasma VWF:RCof . | Plasma FVIII:C . | Plasma VWF:Ag . | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Mean ± SD . | Mean ± SD . | Mean ± SD . | |||||||
| A-SD . | A-SD/HT . | P . | A-SD . | A-SD/HT . | P . | A-SD . | A-SD/HT . | P . | |
| AUCINF | 1295 ± 568 | 1403 ± 918 | .82 | 4995 ± 1843 | 5054 ± 1600 | .95 | 3972 ± 988 | 4369 ± 1442 | .42 |
| CL | 0.05 ± 0.025 | 0.06 ± 0.028 | .84 | 0.01 ± 0.005 | 0.01 ± 0.004 | .78 | 0.02 ± 0.004 | 0.02 ± 0.005 | .63 |
| Vss | 0.50 ± 0.139 | 0.51 ± 0.269 | .92 | 0.38 ± 0.095 | 0.43 ± 0.115 | .32 | 0.28 ± 0.052 | 0.27 ± 0.086 | .97 |
| T1/2 | 7.1 ± 2.89 | 6.5 ± 2.41 | .65 | 20.9 ± 6.68 | 23.8 ± 6.15 | .23 | 12.4 ± 2.13 | 12.9 ± 2.06 | .60 |
| Cmax | 152 ± 44.4 | 180 ± 85.8 | .37 | 192 ± 40.9 | 175 ± 56.3 | .35 | 272 ± 67.2 | 281 ± 96.5 | .90 |
| Tmax | 0.39 ± 0.30 | 0.32 ± 0.23 | .30 | 0.3 ± 0.2 | 0.4 ± 0.3 | .30 | 0.32 ± 0.23 | 0.32 ± 0.23 | .90 |
| Incremental in vivo recovery | 2.5 ± 0.7 | 2.9 ± 1.3 | .32 | 2.04 ± 0.38 | 2.11 ± 0.44 | .58 | ND | ND | — |
AUCINF indicates area under the plasma concentration curve from zero to infinity (% h); CL, clearance (U/kg)/(% h); Vss, volume at steady state (μm/kg per percentage); T1/2, half-life (h); Cmax, maximum concentration (%); Tmax, time to maximum concentration (h); incremental in vivo recovery, % IU/kg; ND, not done.
Patients with type 3 VWD were administered, in random order, 1 infusion of either A-SD or A-SD/HT at a dose of 60 IU/kg WF:RCof, followed 7 or more days later by an identical infusion of the other preparation.P values are from a repeated-measures mixed model with treatment, sequence, and period effects comparing A-SD and A-SD/HT, based on the actual data (no transformations).