drugset / Trial / NCT01650779

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

NCT01650779

Phase 4 Completed 15 enrolled Genzyme, a Sanofi Company
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2012-04
Primary completion
2013-03
Completion
2013-03

Drugs

EvaluationDrugModalityDoseRoute
Subject agalsidase beta Protein / enzyme biologic 1 mg/kg Intravenous

Indications