Clinical trial
Iduronate-2-sulfatase Enzyme Replacement Therapy in Mucopolysaccharidosis II…
NCT00069641 · Shire, Industry · Completed
Key facts
| NCT number | NCT00069641 |
|---|---|
| Title | Iduronate-2-sulfatase Enzyme Replacement Therapy in Mucopolysaccharidosis II (MPS II) |
| Official title | A Phase II/III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Weekly and Every Other Week Dosing Regimens of Iduronate-2-Sulfatase Enzyme Replacement Therapy in Patients With MPS II |
| Lead sponsor | Shire, Industry |
| Status | Completed |
| Phase | Phase 2/Phase 3 |
| Study type | Interventional |
| Conditions | Mucopolysaccharidosis II |
| Intervention type | Biological |
| Interventions | Iduronate-2-sulfatase enzyme replacement therapy, iduronate-2-sulfatase enzyme replacement therapy, Placebo |
| Enrollment | 96 |
| Start date | Sep 18, 2003 |
| Primary completion | Mar 16, 2005 |
| Completion | Mar 16, 2005 |
| First posted | Oct 1, 2003 |
| Last update posted | Jun 10, 2021 |
| Countries | Brazil, Germany, United Kingdom, United States |
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.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: