A Randomized, Open-label, Active Comparator, 2-arm, Prospective Study 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 (BCLEAR1)

NCT04143958 Phase 4 WITHDRAWN

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

Details

Lead sponsor	Sanofi
Phase	Phase 4
Status	WITHDRAWN
Start date	2020-09
Completion	2023-11

Conditions

• Fabry Disease

Interventions

• agalsidase beta (GZ419828)
• agalsidase alfa

Primary outcomes

• Change in Plasma globotriaosylsphingosine (lyso-GL3) level — Baseline, 12 months (week 52)
  Change from baseline to 12 months (week 52) for plasma lyso-GL3 level