Clinical trial
rhGAA in Patients With Infantile-onset Glycogen Storage Disease-II (Pompe…
NCT00053573 · Genzyme, a Sanofi Company, Industry · Completed
Key facts
| NCT number | NCT00053573 |
|---|---|
| Title | rhGAA in Patients With Infantile-onset Glycogen Storage Disease-II (Pompe Disease) |
| Official title | An Open-Label, Multicenter, Multinational, Study of the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of rhGAA Treatment in Patients Greater Than 6 Months and Less Than or Equal to 36 Months Old With Infantile-Onset GSD-II |
| Lead sponsor | Genzyme, a Sanofi Company, Industry |
| Status | Completed |
| Phase | Phase 1/Phase 2 |
| Study type | Interventional |
| Conditions | Glycogen Storage Disease Type II, Pompe Disease, Acid Maltase Deficiency Disease, Glycogenosis 2 |
| Intervention type | Biological |
| Interventions | Myozyme |
| Enrollment | 20 |
| Start date | Feb 1, 2003 |
| Primary completion | Jul 1, 2006 |
| Completion | Nov 1, 2006 |
| First posted | Feb 3, 2003 |
| Last update posted | Feb 5, 2014 |
| Countries | France, Israel, United Kingdom, United States |
At a glance
- 1–9 Study sites
- No 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: