Overview

To Assess the Glycosphingolipid Clearance and Clinical Effects of Switching to Agalsidase Beta (Fabrazyme) Versus Continuing on Agalsidase Alfa (Replagal) in Male Patients With Classic Fabry Disease

Status:
Withdrawn
Trial end date:
2023-11-01
Target enrollment:
Participant gender:
Summary
Primary Objective: To assess reduction of plasma lyso-GL3 level after switch to agalsidase beta from agalsidase alfa Secondary Objectives: - To assess reduction of kidney podocyte GL3 content after switch to agalsidase beta from agalsidase alfa - To assess reduction of GL3 content in endothelial skin cells after switch to agalsidase beta from agalsidase alfa - To assess change in renal function after switch to agalsidase beta from agalsidase alfa - To assess disease severity and clinical changes after switch to agalsidase beta from agalsidase alfa - To assess improvement in symptoms of Fabry disease after switch to agalsidase beta from agalsidase alfa
Phase:
Phase 4
Details
Lead Sponsor:
Sanofi