Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Recombinant Coagulation Factor IX · 1 trial · 1 indication
Annualized bleed rate (ABR) or number of bleeds per year derived for each participant for each treatment regimen by using the following formula: ABR = number of bleeds / (days on treatment regimen / 365.25)
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | - |
| B | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Recombinant Coagulation Factor IX (BeneFIX) | DRUG | 100 IU/kg once weekly then crossover to 50 IU/kg twice weekly |
Inclusion Criteria: * Documented history of moderately severe or severe hemophilia B (FIX:C less than or equal to 2%) * Male subjects, aged 6 years to 65 years. * Subjects with a minimum of 12 bleeding episodes, 6 of which must be joint bleeds, in the 12 months before screening. Exclusion Criteria...
Recombinant Coagulation Factor IX is used for the treatment of Hemophilia B, a bleeding disorder. It is being studied in patients with severe Hemophilia B to compare on-demand treatment with two prophylaxis regimens. The drug is currently in Phase 3 clinical development and is being developed by Pfizer, Inc.
Recombinant Coagulation Factor IX targets and replaces the missing or deficient clotting factor IX in patients with Hemophilia B. By providing the functional factor IX protein, it helps restore the blood's ability to clot properly, reducing the risk of bleeding episodes in affected individuals.
Recombinant Coagulation Factor IX is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 3 clinical trials for the treatment of Hemophilia B.
Recombinant Coagulation Factor IX is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 3 trial is studying its use in patients with severe Hemophilia B, comparing on-demand treatment with two prophylaxis regimens.
Recombinant Coagulation Factor IX is being studied in a Phase 3 clinical trial with the identifier NCT00364182. This completed trial enrolled 50 male patients with severe Hemophilia B and compared on-demand treatment with two prophylaxis regimens. The study was conducted in multiple countries, including the United States, Canada, and several European nations.