A Study Evaluating Glycosphingolipid Clearance in Patients Treated With Agalsidase Alfa Who Switch to Agalsidase Beta

Completed · Phase 4

Conditions studied: Fabry Disease

In brief

This is an exploratory study to evaluate changes in glycosphingolipid levels and other (exploratory) Fabry disease parameters in male Fabry disease participants who were previously treated with agalsidase alfa (Replagal®) 0.2 milligram per kilogram (mg/kg) every two weeks (q2w) and who are being switched to agalsidase beta (Fabrazyme®) 1.0 mg/kg q2w.

Key facts

Study ID

NCT01650779

Run by

Genzyme, a Sanofi Company

People needed

15

Starts

2012-04-01

Expected to finish

2013-03-01

Last updated by the study team

2014-07-10

Who can join

Age: any. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• The participant and/or his parent/legal guardian is willing and able to provide signed informed consent, and the participant, if less than (<) 18 years of age, is willing to provide assent if deemed able to do so
• Participant is male and has been treated with agalsidase alfa at 0.2 mg/kg q2w for the 12 months prior to switching to agalsidase beta
• The participant has a confirmed diagnosis of Fabry disease by alfa-galactosidase A (alfa-GAL) activity and/or genotyping per local standards
• The participant when switched to agalsidase beta receives the labeled dose, that is, 0.9 to 1.1 mg/kg (1 mg/kg) q2w, and must be willing to maintain the labeled dose for the duration of the study

You may not qualify if…

• The participant is on dialysis or is post renal transplantation
• The participant is in end-stage cardiac failure
• The participant and/or his parent or legal guardian, in the opinion of the investigator, is unable to adhere to the requirements of the study
• The participant has been switched from agalsidase alfa to agalsidase beta and does not have historical blood and urine samples

Where it is running

• Study site — Coral Springs, Florida, United States
• Study site — Decatur, Georgia, United States
• Study site — Baltimore, Maryland, United States
• Study site — Grand Rapids, Michigan, United States
• Study site — Hellertown, Pennsylvania, United States
• Study site — Fairfax, Virginia, United States

Full record on ClinicalTrials.gov

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