Clinical Trial: Pharmacokinetics of Alglucosidase Alfa in Patients With Pompe Disease

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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Official Title: A Phase 3/4 Prospective Study to Characterize the Pharmacokinetics of Alglucosidase Alfa in Patients With Pompe Disease

Brief Summary:

• The primary objective of this study is to characterize the pharmacokinetics of alglucosidase alfa manufactured at the 4000 L scale in patients who have a confirmed diagnosis of Pompe disease.
• A secondary objective of this study is to evaluate and explore the relationship between anti-rhGAA antibody titers and the pharmacokinetics of alglucosidase alfa.