drugset / Trial / NCT05843916
Switch Over Study of Biosimilar Agalsidase Beta for Fabry Disease
Phase 3
Completed
20 enrolled
Bio Sidus SA
Amsterdam UMC · collabIQVIA Pty Ltd · collabIQVIA RDS Inc. · collab
NaSingle-groupOpen-labelTreatment
Summary
BIO-AGA-Fase III-001 is a Phase III, prospective, multicenter, open-label, single-group, baseline-controlled, switch over clinical trial to evaluate the efficacy and safety of AGA BETA BS in patients with FD already treated and previously stabilized with Fabrazyme®.
Timeline
- Start
- 2022-12-13
- Primary completion
- 2024-09-19
- Completion
- 2025-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | agalsidase beta | Protein / enzyme biologic | 1 mg/kg | Intravenous |