Pharmacokinetic data for rVWF and rVWF:rFVIII
| . | Mean (SD) . | |||||
|---|---|---|---|---|---|---|
| 95% CI of mean . | ||||||
| 50 IU VWF:RCo/kg . | 80 IU rVWF VWF:RCo/kg . | |||||
| PK1 (N = 15) . | PK2 (N = 13) . | Type 3 VWD only . | ||||
| rVWF:rFVIII (N = 16) . | rVWF (N = 14) . | PK1 (N = 11) . | PK2 (N = 10) . | |||
| T1/2 (h) | 22.5 (9.6) | 22.6 (5.3) | 19.1 (4.3) | 21.0 (5.7) | 19.1 (4.9) | 20.5 (4.7) |
| 17.4-27.6 | 19.5-25.7 | 16.7-21.5 | 17.6-24.5 | 15.8-22.4 | 17.1-23.9 | |
| AUC0-∞/dose ([h*U/dL]/[U VWF:RCo/kg]) | 41.7 (14.8) | 42.1 (8.3) | 36.8 (9.0) | 38.2 (9.1) | 38.4 (7.1) | 38.2 (10.3) |
| 33.8-49.6 | 37.3-46.9 | 31.8-41.8 | 32.8-43.7 | 33.6-43.2 | 30.8-45.5 | |
| Cmax (U/dL) | 95.9 (27.6) | 93.6 (21.0) | 155.7 (31.6) | 150.2 (34.5) | 161.8 (32.3) | 152.5 (30.6) |
| 81.2-110.6 | 81.5-105.8 | 138.2-173.2 | 129.4-171.1 | 140.1-183.5 | 130.6-174.4 | |
| IR at Cmax ([U/dL]/[U VWF:RCo/kg]) | 1.9 (0.5) | 1.9 (0.4) | 2.0 (0.4) | 1.9 (0.4) | 2.0 (0.4) | 1.9 (0.4) |
| 1.6-2.2 | 1.6-2.1 | 1.7-2.2 | 1.6-2.1 | 1.8-2.3 | 1.6-2.2 | |
| CL (dL/kg/h) | 0.027 (0.010) | 0.025 (0.005) | 0.029 (0.009) | 0.028 (0.007) | 0.027 (0.007) | 0.028 (0.008) |
| 0.022-0.032 | 0.022-0.028 | 0.024-0.034 | 0.023-0.032 | 0.023-0.032 | 0.022-0.034 | |
| Vss (dL/kg) | 0.79 (0.27) | 0.77 (0.15) | 0.75 (0.22) | 0.79 (0.26) | 0.71 (0.21) | 0.76 (0.17) |
| 0.64-0.93 | 0.68-0.86 | 0.62-0.87 | 0.63-0.95 | 0.56-0.85 | 0.64-0.88 | |
| MRT (h) | 32.2 (14.5) | 31.9 (7.5) | 26.1 (6.0) | 29.3 (9.8) | 26.3 (6.9) | 28.2 (7.6) |
| 24.4-39.9 | 27.6-36.3 | 22.8-29.5 | 23.4-35.3 | 21.7-30.9 | 22.7-33.6 | |
| . | Mean (SD) . | |||||
|---|---|---|---|---|---|---|
| 95% CI of mean . | ||||||
| 50 IU VWF:RCo/kg . | 80 IU rVWF VWF:RCo/kg . | |||||
| PK1 (N = 15) . | PK2 (N = 13) . | Type 3 VWD only . | ||||
| rVWF:rFVIII (N = 16) . | rVWF (N = 14) . | PK1 (N = 11) . | PK2 (N = 10) . | |||
| T1/2 (h) | 22.5 (9.6) | 22.6 (5.3) | 19.1 (4.3) | 21.0 (5.7) | 19.1 (4.9) | 20.5 (4.7) |
| 17.4-27.6 | 19.5-25.7 | 16.7-21.5 | 17.6-24.5 | 15.8-22.4 | 17.1-23.9 | |
| AUC0-∞/dose ([h*U/dL]/[U VWF:RCo/kg]) | 41.7 (14.8) | 42.1 (8.3) | 36.8 (9.0) | 38.2 (9.1) | 38.4 (7.1) | 38.2 (10.3) |
| 33.8-49.6 | 37.3-46.9 | 31.8-41.8 | 32.8-43.7 | 33.6-43.2 | 30.8-45.5 | |
| Cmax (U/dL) | 95.9 (27.6) | 93.6 (21.0) | 155.7 (31.6) | 150.2 (34.5) | 161.8 (32.3) | 152.5 (30.6) |
| 81.2-110.6 | 81.5-105.8 | 138.2-173.2 | 129.4-171.1 | 140.1-183.5 | 130.6-174.4 | |
| IR at Cmax ([U/dL]/[U VWF:RCo/kg]) | 1.9 (0.5) | 1.9 (0.4) | 2.0 (0.4) | 1.9 (0.4) | 2.0 (0.4) | 1.9 (0.4) |
| 1.6-2.2 | 1.6-2.1 | 1.7-2.2 | 1.6-2.1 | 1.8-2.3 | 1.6-2.2 | |
| CL (dL/kg/h) | 0.027 (0.010) | 0.025 (0.005) | 0.029 (0.009) | 0.028 (0.007) | 0.027 (0.007) | 0.028 (0.008) |
| 0.022-0.032 | 0.022-0.028 | 0.024-0.034 | 0.023-0.032 | 0.023-0.032 | 0.022-0.034 | |
| Vss (dL/kg) | 0.79 (0.27) | 0.77 (0.15) | 0.75 (0.22) | 0.79 (0.26) | 0.71 (0.21) | 0.76 (0.17) |
| 0.64-0.93 | 0.68-0.86 | 0.62-0.87 | 0.63-0.95 | 0.56-0.85 | 0.64-0.88 | |
| MRT (h) | 32.2 (14.5) | 31.9 (7.5) | 26.1 (6.0) | 29.3 (9.8) | 26.3 (6.9) | 28.2 (7.6) |
| 24.4-39.9 | 27.6-36.3 | 22.8-29.5 | 23.4-35.3 | 21.7-30.9 | 22.7-33.6 | |
Cmax, maximum concentration; PK1, initial PK assessment; PK2, PK assessment 6 mo after initial PK; SD, standard deviation.