Immune Response in Subjects With Fabry Disease Who Are Switching From Agalsidase Alfa to Agalsidase Beta

Completed

Conditions studied: Fabry Disease

In brief

This study is a prospective active comparator study to assess the immune response elicited by human recombinant agalsidase therapy in subjects who are switching from agalsidase alfa to agalsidase beta with Fabry disease. Fabry disease is an X-linked lysosomal storage disorder, due to deficient alpha-galactosidase A activity. The progressive accumulation of globotriaosylceramide (GL-3) in the lysosomes of the vascular endothelial cells of multiple organ systems like the kidneys, heart, skin, and brain, leads to a microvascular disease. In Fabry disease, nephropathy dominates and renal function impairment occurs as a result of accumulation of GL-3 in renal cells

Key facts

Study ID

NCT01745185

Run by

O & O Alpan LLC

People needed

30

Starts

2012-06-01

Expected to finish

2016-08-07

Last updated by the study team

2017-04-04

Who can join

Age: 7 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed diagnosis of Fabry disease
• Have been treated with ERT using recombinant human agalsidase A.

You may not qualify if…

• If the diagnosis of Fabry disease is not confirmed
• If the subject or guardian is not able to provide consent
• Any chronic immunosuppressive state or therapy such as patients on dialysis or post-transplantation immunosuppressive therapy.

Where it is running

• O&O Alpan — Fairfax, Virginia, United States

Full record on ClinicalTrials.gov

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