Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
moroctocog alfa · 2 trials · 1 indication
ABR for each participant was calculated as the number of bleeds requiring administration of moroctocog alfa (AF-CC) divided by the total therapy duration (in days), then multiplied by 365.25 (days in a year).
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | On-Demand therapy for 6 months, followed by Routine Prophylaxis treatment for 1 year. |
| 2 | EXPERIMENTAL | Routine Prophylaxis Crossover |
| Sequence 1 | EXPERIMENTAL | Subjects randomized to receive Treatment A during Period 1, then Treatment B during Period 2. |
| Sequence 2 | EXPERIMENTAL | Subjects randomized to receive Treatment B during Period 1, then Treatment B during Period 2. |
| Name | Type | Description |
|---|---|---|
| Moroctocog alfa (AF-CC) | BIOLOGICAL | On-demand therapy for 6 months, followed by routine prophylaxis 25 IU/kg, administered every other day for 1 year. |
Inclusion Criteria: * Male subjects, aged less than 6 years, with moderately severe to severe hemophilia A. * A negative FVIII inhibitor titer at screening, and a medical history negative for a past FVIII inhibitor. * At least 20 exposure days to any FVIII replacement product. * Adequate hepatic an...
Moroctocog alfa is used for hemophilia A, a bleeding disorder caused by a deficiency in clotting factor VIII. It is being developed by Pfizer, Inc. as a treatment for this condition. The drug is currently in clinical development and has completed Phase 3 trials.
Moroctocog alfa targets factor VIII, the clotting protein that is deficient or defective in people with hemophilia A. By replacing this missing factor, the drug aims to restore normal blood clotting and reduce bleeding episodes in patients.
Moroctocog alfa is developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. Pfizer is conducting clinical trials to evaluate the drug's safety and efficacy in treating hemophilia A.
Moroctocog alfa is in Phase 3 clinical development for hemophilia A. It has completed two clinical trials, including a Phase 3 study and a Phase 1 study. The drug is investigational and has not been approved by regulatory authorities.
Moroctocog alfa has been studied in two completed clinical trials. NCT00543439 was a Phase 3 study evaluating prophylaxis treatment and characterizing efficacy, safety, and pharmacokinetics of B-domain deleted recombinant FVIII in 66 male patients with hemophilia A. NCT01579903 was a Phase 1 study assessing the relative bioavailability of two formulations of moroctocog alfa in 16 male patients.
Moroctocog alfa is a B-domain deleted recombinant factor VIII, as indicated in the Phase 3 trial title. This means it is a modified version of factor VIII that lacks the B-domain, which is not required for clotting activity. This modification may affect the drug's production and stability.