Clinical trial
High Dose or High Dose Frequency Study of Alglucosidase Alfa
NCT00483379 · Genzyme, a Sanofi Company, Industry · Completed
Key facts
| NCT number | NCT00483379 |
|---|---|
| Title | High Dose or High Dose Frequency Study of Alglucosidase Alfa |
| Official title | An Exploratory, Open-Label Study of the Safety and Efficacy of High Dose or High Dosing Frequency Alglucosidase Alfa Treatment in Patients With Pompe Disease Who Do Not Have an Optimal Response to the Standard Dose Regimen |
| Lead sponsor | Genzyme, a Sanofi Company, Industry |
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional |
| Conditions | Pompe Disease, Glycogen Storage Disease Type II (GSD-II), Glycogenesis 2 Acid Maltase Deficiency |
| Intervention type | Biological |
| Interventions | alglucosidase alfa |
| Enrollment | 13 |
| Start date | May 1, 2007 |
| Primary completion | Dec 1, 2009 |
| Completion | Jul 1, 2010 |
| First posted | Jun 7, 2007 |
| Last update posted | Mar 7, 2014 |
| Countries | Australia, Canada, United States |
At a glance
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: