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Clinical trial

A Phase 3/4, Prospective, Multinational, Open-label, Noninferiority Study of Alglucosidase Alfa Manufactured at the 160 L and 4000 L Scales in Treatment Naïve Patients With Infantile-Onset Pompe Disease

NCT01597596 is registered in ClinicalTrials.gov with Genzyme, a Sanofi Company as lead sponsor.

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Registry record

As filed in ClinicalTrials.gov.

Title
A Phase 3/4, Prospective, Multinational, Open-label, Noninferiority Study of Alglucosidase Alfa Manufactured at the 160 L and 4000 L Scales in Treatment Naïve Patients With Infantile-Onset Pompe Disease
Lead sponsor
Genzyme, a Sanofi Company
Phase
Phase 4
Overall status
Terminated
Start date
August 31, 2012
Completion date
December 31, 2014
Enrollment
4 (actual)
Sites
17

Conditions

As the registry lists them; a condition with its own page is linked.

acid maltase deficiency, glycogen storage disease type ii (gsd ii), glycogenosis 2, pompe disease (infantile-onset)