Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:10 PM
Study NCT ID:
NCT04143958
Status:
WITHDRAWN
Last Update Posted:
2023-04-07
First Post:
2019-10-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Sanofi
Organization:
Study Overview
Official Title:
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
Status:
WITHDRAWN
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The Sponsor terminated the study due to recruitment infeasibility without having enrolled any patient.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BCLEAR1
Brief 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
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
Detailed Description:
The study will have a screening period of up to 9 weeks. Eligible participants will be randomized to switch to agalsidase beta or to continue agalsidase alfa in a 1:1 ratio for a period of 12 months (52 weeks).
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: