Approval Probability
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Adjusted LOA
ML Risk
BAY94-9027 · 2 trials · 1 indication
Pharmacokinetics profile includes maximum concentration (Cmax), half-life (t1/2), area under the concentration versus time curve (AUC), mean residence time (MRT), volume of distribution at steady state (Vss), and clearance (CL)
Annualized number of total bleeds was defined as the annualized sum of spontaneous bleeds and trauma bleeds. A participant who had the one-time increase in dose frequency was regarded as rescued. A rescue bleed was a bleed that occured after the dose frequency was increased. Rescue bleeds and periods were not considered for the annualized bleeding rate (ABR).
| Arm | Type | Description |
|---|---|---|
| Main study | EXPERIMENTAL | Participants were treated and prophylaxis administered with BAY94-9027 at a dose of 25-60 international units/kilogram (IU/kg) twice per week or 45-60 IU/kg every 5 days or 60 IU/kg every 7 days as an intravenous (IV) infusion as per clinical needs of each subject up to at least 50 exposure days (EDs) and a minimum of at least 6 months. |
| Part 2 (Expansion group) | EXPERIMENTAL | Participants were administered with BAY94-9027 at a dose of 25-60 IU/kg twice per week for prophylaxis for 12 weeks. |
| Extension study | EXPERIMENTAL | Participants were treated and prophylaxis administered with BAY94-9027 at a dose of 25- 60 IU/kg twice per week or 45-60 IU/kg every 5 days or 60 IU/kg every 7 days as an IV infusion as per clinical needs of each subject for at least 50 EDs or until marketing authorization of the drug. |
| Arm 1 | EXPERIMENTAL | On-demand treatment of BAY94-9027 at individual dose and number of infusions based upon location and severity of bleeds |
| Arm 2 | EXPERIMENTAL | Prophylaxis treatment of BAY94-9027; 2 infusions per week over 10 weeks followed by 2 infusions per week over 26 weeks in the main trial; and at least 1 day per week in the extension for at least 100 ED |
| Arm 3 | EXPERIMENTAL | Prophylaxis treatment of BAY94-9027; 2 infusions per week over 10 weeks followed by infusion every 5 days over 26 weeks in the main trial; and at least 1 day per week in the extension for at least 100 ED |
| Arm 4 | EXPERIMENTAL | Prophylaxis treatment of BAY94-9027; 2 infusions per week over 10 weeks followed by infusion every 7 days over 26 weeks in the main trial; and at least 1 day per week in the extension for at least 100 ED |
| Name | Type | Description |
|---|---|---|
| BAY94-9027 | BIOLOGICAL | Study drug dosing was adjusted to the clinical needs of each subject in the range of 25-60 IU/kg/administration, intravenous infusion, at least 50 EDs and a minimum of at least 6 months |
Inclusion Criteria: * Males \< 12 years of age * Subjects with severe hemophilia A * Previously treated with FVIII for \> 50 exposure days Exclusion Criteria: * Subjects with current evidence of or history of inhibitors to FVIII * Any other inherited or acquired bleeding disorder * Platelet count...
BAY94-9027 is an investigational drug being developed for the treatment of hemophilia A, a bleeding disorder. It is a monoclonal antibody under evaluation in clinical trials for patients with this condition. The drug is not yet approved and remains in clinical development.
BAY94-9027 is being developed by Bayer AG, a pharmaceutical company. Bayer is conducting clinical trials to evaluate the safety and efficacy of this drug in patients with hemophilia A.
BAY94-9027 is in Phase 3 clinical development. It has completed Phase 2 and Phase 3 trials, including studies in adults and children with severe hemophilia A. The drug is investigational and has not been approved by regulatory authorities.
BAY94-9027 has been studied in two completed clinical trials. NCT01580293 was a Phase 2 trial in 145 patients with severe hemophilia A, and NCT01775618 was a Phase 3 trial in 73 previously treated male children with hemophilia A. Both trials are completed.
BAY94-9027 is a monoclonal antibody designed to target a specific pathway involved in blood clotting. By modulating this pathway, it aims to improve hemostasis in patients with hemophilia A, reducing the risk of bleeding episodes.