| Company Name | Sanofi |
|---|---|
| Protocol Number | OBS17349 |
| Title of Study | An Observational Study of Enzyme Replacement Therapy-Naïve and Agalsidase beta-Treated Fabry Disease Patients with GLA IVS4+919 G>A Mutation in Taiwan |
| Primary Objective | Cohort 1 (C1) To assess change from baseline for a key cardiac outcome in Fabry disease patients who bear GLA IVS4 and have received agalsidase beta treatment. Cohort 2 (C2) To assess change from baseline for a key cardiac outcome in Fabry disease patients who bear GLA IVS4 and will initiate agalsidase beta treatment. |
| Number of Sites | 5 |
| Period of Study | From：2023/03/10 to：2027/02/25 |
| Number of Patients | 100人 |
| IRB Approval Date | NTUH: 7/25/2023 TPVGH: 8/30/2023 MMH: 9/26/2023 TCVGH: 7/26/2023 NCKUH: 8/1/2023 |
| Publication Plan / Date | Unknown |
