Table 4.
Phase I/II studies | Estimates of D with trough = 0.15 IU/ml and tau = 12 h | Estimates of tau with trough = 0.15 IU/ml and D = 10 IU/kg/h | Ref. | ||||||
---|---|---|---|---|---|---|---|---|---|
FVIII concentrate | Trade name | Dose (IU/kg) | Clearance (ml/h/kg) | FVIII (IU/ml) | Tau (h) | Dose (IU/kg/12 h) | Tau (h) | Dose (IU/kg/tau) | |
Turoctocog alfa GP | NovoEight GP | 75 | 1.9 | 0.15 | 12 | 3.4 | 35 | 10 | Powell and colleagues43 |
Turoctocog alfa | NovoEight® | 50 | 4.17 | 0.15 | 12 | 7.5 | 16 | 10 | |
Octocog alfa | Advate® | 50 | 4.24 | 0.15 | 12 | 7.6 | 16 | 10 | |
Damoctocog alfa pegol | BAY 94-9027 | 25 | 1.6 | 0.15 | 12 | 2.9 | 42 | 10 | Collins and colleagues44 |
Octocog alfa-sucrose formulated | rFVIII-FS | 25 | 2.3 | 0.15 | 12 | 4.1 | 29 | 10 | |
Octocog alfa PEG | BAX 855 | 30 | 2.76 | 0.15 | 12 | 5.0 | 24 | 10 | Stidl and colleagues16 |
Octocog alfa | Advate® | 30 | 4.55 | 0.15 | 12 | 8.2 | 15 | 10 | |
Ionoctocog alfa | FVIII-SingleChain | 50 | 2.64 | 0.15 | 12 | 4.8 | 25 | 10 | Collins and colleagues49 |
Octocog alfa | Advate® | 50 | 3.68 | 0.15 | 12 | 6.6 | 18 | 10 | |
Efraloctocog alfa | Eloctate® | 25 | 1.68 | 0.15 | 12 | 3.0 | 40 | 10 | Santagostino and colleagues45 |
Octocog alfa | Advate® | 25 | 2.49 | 0.15 | 12 | 4.5 | 27 | 10 | |
Efraloctocog alfa | Eloctate® | 65 | 2.32 | 0.15 | 12 | 4.2 | 29 | 10 | |
Octocog alfa | Advate® | 65 | 3.61 | 0.15 | 12 | 6.5 | 18 | 10 | |
Simoctocog | Nuwiq® | 45 | 4.73 | 0.15 | 12 | 8.5 | 14 | 10 | Morfini46 |
ABR, annualized bleeding rate; EHL, extended half-life; PK, pharmacokinetics; rF, recombinant factor.