Clinical trial
Phase 3 Extension Study of the Safety and Efficacy of Aldurazyme® (Laronidase)…
NCT00146770 · Genzyme, a Sanofi Company, Industry · Completed
Key facts
| NCT number | NCT00146770 |
|---|---|
| Title | Phase 3 Extension Study of the Safety and Efficacy of Aldurazyme® (Laronidase) in Mucopolysaccharidosis I (MPS I) Patients |
| Official title | A Multicenter, Multinational, Open-Label Extension Study of the Safety and Efficacy of Aldurazyme® (Laronidase) in Patients With Mucopolysaccharidosis I |
| Lead sponsor | Genzyme, a Sanofi Company, Industry |
| Collaborators | BioMarin/Genzyme LLC Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Mucopolysaccharidosis I, Hurler's Syndrome, Hurler-Scheie Syndrome, Scheie Syndrome |
| Intervention type | Biological |
| Interventions | Aldurazyme, placebo |
| Enrollment | 45 |
| Start date | May 1, 2001 |
| Primary completion | Mar 1, 2005 |
| Completion | Mar 1, 2005 |
| First posted | Sep 7, 2005 |
| Last update posted | Apr 3, 2015 |
| Countries | Brazil, Canada, Germany, Italy, Netherlands, United Kingdom, United States |
At a glance
- 10–99 Study sites
- 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: