Safety Study of Replagal® Therapy in Children With Fabry Disease

Status Completed

Clinical Trial Summary

The purpose of this study is to assess the safety of Replagal in children with Fabry disease who who have not previously been treated with enzyme replacement therapy (ERT).

Clinical Trial Description

In 2008, a change in the agalsidase alfa drug substance manufacturing process was made. There are no changes to the drug product formulation, manufacturing site, manufacturing process, or container closure. An agalsidase alfa bioreactor manufacturing process (agalAF1) utilizing animal component-free media replaced the previous roller bottle (RB) process. This study will evaluate the safety of Replagal AF, manufactured using the new bioreactor process at a dose of 0.2 mg/kg infused IV over 40 minutes, every other week (EOW) in children with Fabry disease who are 7 years to less than 18 years of age and who are naive to ERT. ;

Study Design

Related Conditions & MeSH terms

Fabry Disease

Clinical Trial Details

NCT number	NCT01363492
Study type	Interventional
Source	Takeda
Contact
Status	Completed
Phase	Phase 2
Start date	May 12, 2011
Completion date	April 17, 2013

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See also
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