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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

NCT04143958 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2023-04-07

No results posted yet for this study

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

Conditions

Interventions

DRUG

agalsidase beta (GZ419828)

Pharmaceutical form:Powder for concentrate for solution for infusion Route of administration: Intravenous (IV) infusion,

DRUG

agalsidase alfa

Pharmaceutical form:concentrate for solution for infusion Route of administration: Intravenous (IV) infusion

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-30
Primary Completion
2023-11-30
Completion
2023-11-30
FDA Drug
Yes

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04143958 on ClinicalTrials.gov