Clinical trial
A Study of the Safety and Efficacy of rhGAA in Patients With Infantile-onset…
NCT00059280 · Genzyme, a Sanofi Company, Industry · Completed
Key facts
| NCT number | NCT00059280 |
|---|---|
| Title | A Study of the Safety and Efficacy of rhGAA in Patients With Infantile-onset Pompe Disease |
| Official title | An Open-label, Multicenter, Multinational Study of the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Recombinant Human Acid Alpha-glucosidase Treatment in Patients Less Than 6 Months Old With Infantile-onset Pompe Disease |
| Lead sponsor | Genzyme, a Sanofi Company, Industry |
| Status | Completed |
| Phase | Phase 2/Phase 3 |
| Study type | Interventional |
| Conditions | Glycogen Storage Disease Type II |
| Intervention type | Biological |
| Interventions | Myozyme |
| Enrollment | 16 |
| Start date | Apr 1, 2003 |
| Primary completion | Jun 1, 2005 |
| Completion | Sep 1, 2005 |
| First posted | Apr 23, 2003 |
| Last update posted | Feb 5, 2014 |
| Countries | France, Israel, Taiwan, 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: