Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01286779 | BAX 326 (rFIX) Continuation Study | PHASE3 | COMPLETED | 117 | — | — | Apr 12, 2011 | Jun 29, 2017 | May 20, 2021 | 42 | Argentina, Brazil +15 |
| NCT01174446 | Pivotal Study (Pharmacokinetics, Efficacy, Safety) of BAX 326 (rFIX) in Hemophilia B Patients | PHASE3 | COMPLETED | 86 | — | — | Jul 29, 2010 | May 3, 2012 | May 20, 2021 | 25 | Argentina, Brazil +12 |
| NCT01488994 | BAX 326 Pediatric Study | PHASE2 | COMPLETED | 23 | — | — | Dec 20, 2011 | May 14, 2013 | May 20, 2021 | 11 | India, Poland +4 |
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...