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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01335061 | Study To Compare On-Demand Treatment To A Prophylaxis Regimen Of BeneFIX In Subjects With Moderately Severe to Severe Hemophilia B | PHASE3 | COMPLETED | 25 | — | — | Sep 1, 2011 | Apr 1, 2014 | Jun 8, 2015 | 17 | Bulgaria, Canada +7 |
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...