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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01945593 | BAX 855 Continuation | PHASE3 | COMPLETED | 218 | — | — | Oct 15, 2013 | Mar 2, 2018 | May 24, 2021 | 89 | United States, Australia +21 |
Inhibitory antibodies to Factor VIII were measured by the Nijmegen modification of the Bethesda assay. Inhibitors had to be confirmed by 2 separate assessments within a 2 to 4 week period from the central laboratory.
The ABR was assessed based upon each individual bleeding episode. A bleeding episode was defined as subjective (pain consistent with a joint bleed) or objective evidence of bleeding which may or may not require treatment with FVIII. The ABR of spontaneous bleeds was reported separately for twice weekly, PK-t R, each of the every 5 days and every 7 days treatment regimens at the time of bleed.
| Arm | Type | Description |
|---|---|---|
| Fixed BAX855 prophylaxis | EXPERIMENTAL | 45-80 IU/kg twice weekly to once per week. |
| Pharmacokinetic (PK)-tailored BAX 855 prophylaxis | EXPERIMENTAL | PK-tailored prophylactic BAX855 regimen based on participant's individual PK profile to maintain a Factor VIII (FVIII) trough level |
| Name | Type | Description |
|---|---|---|
| BAX855 | BIOLOGICAL | Antihemophilic Factor (Recombinant), PEGylated |
INCLUSION CRITERIA Participants Transitioning from Other BAX 855 Studies: Participants transitioning from other BAX 855 studies can be provided with the continuation study informed consent form (ICF) prior to the end of study visit to review and consider participation in this continuation study. T...