drugset / Trial / NCT03566017
Open Label Extension Study of 1 mg/kg Pegunigalsidase Alfa Every 2 Weeks in Patients With Fabry Disease
NaSingle-groupOpen-labelTreatment
Summary
The objective of CLI-06657AA1-04 (formerly PB-102-F60) was to evaluate the long-term safety, tolerability, and efficacy parameters of 1 mg/kg pegunigalsidase alfa administered intravenously every other week in adult Fabry patients who had successfully completed studies PB-102-F20, PB-102-F30, or at least 48 months in study PB-102-F03.
Timeline
- Start
- 2018-09-16
- Primary completion
- 2025-01-21
- Completion
- 2025-01-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | pegunigalsidase alfa | Protein / enzyme biologic | 1 mg/kg | Intravenous |