Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Antihemophilic Factor (Recombinant), Antihemophilic Factor
Antihemophilic factor, recombinant, manufactured protein-free · 4 trials · 1 indication
Terminal phase half-life of rAHF-PFM was to be determined using the biphasic linear regression model.
Area under the factor VIII (FVIII) plasma concentration versus time curve (AUC) from 0 to 48 hours estimated using the linear trapezoidal method
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | ADVATE reconstituted in 2 mL sterile water for infusion |
| 2 | ACTIVE_COMPARATOR | ADVATE reconstituted in 5 mL sterile water for infusion |
| Name | Type | Description |
|---|---|---|
| Antihemophilic factor, recombinant, manufactured protein-free | DRUG | - |
| Antihemophilic factor, recombinant, manufactured protein-free (rAHF-PFM). (Antihemophilic factor is also known as Factor VIII) | BIOLOGICAL | Subjects are randomized to receive an infusion of rAHF-PFM reconstituted in 2 mL sterile water for infusion (SWFI) followed (after a wash-out period) by rAHF-PFM reconstituted in 5 mL SWFI or in 5 mL then 2 mL SWFI(cross-over design). Each subject will receive 2 infusions. |
Inclusion Criteria: * Subject is less than 6 years of age * Severe or moderately-severe hemophilia A as defined by a baseline factor VIII level \<= 2%, documented at screening or on the basis of historical data (e.g., at hemophilia diagnosis) * Documented medical history of at least 50 exposure day...