Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAX326 · 3 trials · 1 indication
Possibly or probably related adverse events that occurred during or after first BAX326 infusion.
Computed using the linear trapezoidal method. The concentration at 72 hours was interpolated from the two nearest sampling time points or extrapolated using the last quantifiable concentration and the terminal rate constant λz. λz was estimated from the slope of natural log-linear fitting to latter quantifiable concentrations, with largest adjusted R\^2.
| Arm | Type | Description |
|---|---|---|
| BAX 326 | EXPERIMENTAL | - |
| BeneFIX | ACTIVE_COMPARATOR | Recombinant Factor IX (rFIX) |
| BAX326 < 6 years of age | EXPERIMENTAL | - |
| BAX326 6 to <12 years of age | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| BAX 326 (Recombinant factor IX) | BIOLOGICAL | The treatment with BAX 326 will be at the discretion of the investigator and will consist of either twice weekly prophylactic treatment with 50 IU/kg, modified prophylaxis, or on-demand treatment. |
| BAX 326 | BIOLOGICAL | * Study Part 1: Pharmacokinetic (PK) Crossover with BAX326 and BeneFIX * Study Part 2: Open-label evaluation of prophylaxis and on-demand BAX326 only * Study Part 3: Open-label repeat of PK evaluation (repeat Study Part 1) with BAX326 only and same study participants as Study Part 1 |
| BeneFIX | BIOLOGICAL | * Study Part 1: Pharmacokinetic (PK) Crossover with BAX326 and BeneFIX. * BeneFIX only used in Part 1 of this study. * Study Part 2 and 3 only utilized BAX326 |
| BAX326 | BIOLOGICAL | All participants underwent a pharmacokinetic evaluation with BAX326 (recombinant Factor IX) followed by twice weekly prophylactic treatment for 6 months or for at least 50 exposure days, whichever occurred last. |
Main Inclusion Criteria: * Subject and/or legal representative has/have voluntarily provided signed informed consent * Subject has completed Baxter clinical study 250901 (pivotal study) or Baxter clinical study 251101 (pediatric study) * Subject was 12 to 65 years old at the time of screening for S...
BAX326 is an investigational therapy for hemophilia B, a bleeding disorder caused by a deficiency in clotting factor IX. It is being developed as a recombinant factor IX replacement to control and prevent bleeding episodes in patients with this condition. The drug is currently in clinical development and has not been approved by regulatory authorities.
BAX326 is being developed by Takeda Pharmaceutical Company Limited, a global biopharmaceutical company listed on the Tokyo Stock Exchange under the ticker TAK. Takeda is conducting clinical trials to evaluate the safety and efficacy of BAX326 in patients with hemophilia B.
BAX326 is in Phase 3 clinical development for hemophilia B. It has completed three clinical trials, including a pivotal Phase 3 study, a continuation study, and a pediatric study. The drug remains investigational and is not yet approved for commercial use.
BAX326 has completed three clinical trials: NCT01174446, a pivotal Phase 3 study in hemophilia B patients; NCT01286779, a continuation study; and NCT01488994, a pediatric study. All trials are completed, with a total enrollment of 226 participants across multiple countries.
BAX326 is also known as rFIX, which stands for recombinant factor IX. It is a form of clotting factor IX produced through recombinant DNA technology. This alternative name is used in clinical trial titles and medical literature to describe the same investigational therapy for hemophilia B.