Clinical trial
Randomized, Controlled, Open-label, Multicenter, Safety and Efficacy Study of…
NCT02060526 · Shire, Industry · Completed
Key facts
| NCT number | NCT02060526 |
|---|---|
| Title | Randomized, Controlled, Open-label, Multicenter, Safety and Efficacy Study of rhHNS Administration Via an IDDD in Pediatric Patients With Early Stage MPS IIIA Disease |
| Official title | A Randomized, Controlled, Open-label, Multicenter, Phase IIb Safety and Efficacy Study of rhHNS (Recombinant Human Heparan N Sulfatase) Administration Via an Intrathecal Drug Delivery Device in Pediatric Patients With Early Stage Mucopolysaccharidosis Type IIIA Disease |
| Lead sponsor | Shire, Industry |
| Status | Completed |
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Sanfilippo Syndrome |
| Intervention type | Drug |
| Interventions | Recombinant human heparan N-sulfatase [rhHNS] |
| Enrollment | 21 |
| Start date | Feb 26, 2014 |
| Primary completion | Jun 1, 2016 |
| Completion | Jun 1, 2016 |
| First posted | Feb 12, 2014 |
| Last update posted | Jun 8, 2021 |
| Countries | Argentina, France, Germany, Italy, Netherlands, Spain, 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: