Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nonacog alfa · 1 trial · 1 indication
The annualized bleed rate (ABR) or the annualized number of bleeding episodes per year, will be derived for each participant for each treatment period by using the following formula: ABR = number of bleeds / (Days on treatment period / 365.25) The number of bleeds for the ABR calculation includes all bleeds requiring treatment with factor IX product during the time on treatment.
| Arm | Type | Description |
|---|---|---|
| BeneFIX | OTHER | - |
| Name | Type | Description |
|---|---|---|
| Nonacog alfa | BIOLOGICAL | Period 1: During on-demand period, dosing at the discretion of investigator. |
Inclusion Criteria: * Documented history of moderately-severe to severe hemophilia B (FIX activity \</=2%). * Male subjects, aged 12 years to 65 years. * Subjects with at least 100 exposure days (EDs) to factor IX products. * Subjects with a minimum of 12 bleeding episodes, 6 of which must be joint...
Nonacog alfa is a recombinant coagulation factor IX product used for the treatment of Hemophilia B. It is being developed by Pfizer, Inc. as a therapy for patients with moderately severe to severe Hemophilia B, and it is currently in Phase 3 clinical development.
Nonacog alfa targets and replaces coagulation factor IX, which is deficient or defective in patients with Hemophilia B. By providing functional factor IX, it helps restore the blood clotting process and reduce bleeding episodes in affected individuals.
Nonacog alfa is developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical trials to evaluate the safety and efficacy of Nonacog alfa for the treatment of Hemophilia B.
Nonacog alfa is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities and is still being studied in clinical trials to assess its safety and effectiveness for treating Hemophilia B.
Nonacog alfa has one completed Phase 3 clinical trial, identified as NCT01335061. This study compared on-demand treatment to a prophylaxis regimen of BeneFIX in subjects with moderately severe to severe Hemophilia B. The trial enrolled 25 male participants aged 12 years and older across multiple countries.
Nonacog alfa is the same as BeneFIX, as the clinical trial NCT01335061 refers to BeneFIX as the study drug. BeneFIX is a brand name for nonacog alfa, a recombinant factor IX product used for the management of Hemophilia B.