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)