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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00364182 | Study Comparing On-Demand Treatment With Two Prophylaxis Regimens Of BeneFIX In Patients With Severe Hemophilia B | PHASE3 | COMPLETED | 50 | — | — | May 1, 2007 | Oct 1, 2010 | Oct 4, 2011 | 19 | United States, Canada +7 |
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...