Clinical trial
A Study Evaluating the Safety and Pharmacokinetics of Aldurazyme® (Laronidase)…
NCT00146757 · Genzyme, a Sanofi Company, Industry · Completed
Key facts
| NCT number | NCT00146757 |
|---|---|
| Title | A Study Evaluating the Safety and Pharmacokinetics of Aldurazyme® (Laronidase) in MPS I Patients Less Than 5 Years Old |
| Official title | A Phase II Open-Label Clinical Trial of Recombinant Human Alpha-L-iduronidase (Aldurazyme®) to Evaluate the Safety and Pharmacokinetics in Mucopolysaccharidosis I (MPS I) Patients Less Than 5 Years Old |
| Lead sponsor | Genzyme, a Sanofi Company, Industry |
| Collaborators | BioMarin/Genzyme LLC Industry |
| Status | Completed |
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Mucopolysaccharidosis I, Hurler Syndrome, Hurler-Scheie Syndrome, Scheie Syndrome |
| Intervention type | Biological |
| Interventions | Aldurazyme (Recombinant Human Alpha-L-Iduronidase) |
| Enrollment | 20 |
| Start date | Oct 1, 2002 |
| Primary completion | May 1, 2005 |
| Completion | May 1, 2005 |
| First posted | Sep 7, 2005 |
| Last update posted | Apr 3, 2015 |
| Countries | France, Germany, Netherlands, United Kingdom |
At a glance
- 1–9 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.
About ClinicalTrials.gov studies
ClinicalTrials.gov is the U.S. National Library of Medicine's registry of clinical studies conducted around the world. Contact and investigator details are not shown here.
Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: