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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03018730 | Safety and Efficacy of PRX-102 in Patients With Fabry Disease Currently Treated With REPLAGAL® (Agalsidase Alfa) | PHASE3 | COMPLETED | 22 | — | — | May 1, 2017 | Jan 1, 2020 | Sep 12, 2023 | - | — |
| NCT02795676 | Study of the Safety and Efficacy of PRX-102 Compared to Agalsidase Beta on Renal Function | PHASE3 | COMPLETED | 78 | — | — | Jun 1, 2016 | Jul 1, 2022 | Sep 12, 2023 | - | — |
| NCT01981720 | Extension Study of PRX-102 for up to 60 Months | PHASE1/PHASE2 | COMPLETED | 15 | — | — | Jan 1, 2014 | Nov 1, 2021 | Sep 12, 2023 | - | — |
| NCT01678898 | Dose-ranging Study of PRX-102 in Adult Fabry Disease Patients | PHASE1/PHASE2 | COMPLETED | 18 | — | — | Oct 1, 2012 | Mar 1, 2016 | Sep 12, 2023 | - | — |
| Name | Type | Description |
|---|---|---|
| PRX-102 (pegunigalsidase alfa) | BIOLOGICAL | PRX-102 1 mg/kg every 2 weeks |
| agalsidase beta | BIOLOGICAL | agalsidase beta 1 mg/kg every 2 weeks |
| PRX-102 | DRUG | - |