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BRIDGE: PRX-102 Switch Study in Fabry Disease
NCT03018730Phase 3
Key facts
- Status
- Completed
- Start
- May 2017
- Primary completion
- Dec 2019
- Countries
- 7
- Sponsor
- Protalix BioTherapeutics
- Modality
- PEGylated Peptides, Replacement Enzymes
- Drugs
- pegunigalsidase alfa
- Conditions
- Fabry disease (FD)
01
Overview
Phase 3, open-label, single-arm trial of pegunigalsidase alfa in Fabry disease (FD), sponsored by Protalix BioTherapeutics. Primary endpoint: Number of Participants With Treatment-related Adverse Events at 12 months. Started May 2017; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
PRX-102
Switch from Agalsidase Alfa to PRX-102
03
Endpoints
Primary
Number of Participants With Treatment-related Adverse Events
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