Trials / Terminated
TerminatedNCT02350816
An Extension Study to Determine Safety and Efficacy for Pediatric Patients With MPS Type IIIA Disease Who Participated in Study HGT-SAN-093.
An Open-Label Extension of Study HGT-SAN-093 Evaluating the Safety and Efficacy Study of HGT-1410 (Recombinant Human Heparan N Sulfatase) Administration Via an Intrathecal Drug Delivery Device in Pediatric Patients With Mucopolysaccharidosis Type IIIA Disease
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 17 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- 12 Months – 48 Months
- Healthy volunteers
- Not accepted
Summary
This extension study will allow participants to continue receiving treatment with HGT-1410 and to initiate treatment in patients who received no-treatment in Study HGT-SAN-093, and will evaluate the long-term safety and efficacy of the study drug.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HGT-1410 | HGT-1410 administered according to Patient Group assignment. |
Timeline
- Start date
- 2015-04-08
- Primary completion
- 2019-04-12
- Completion
- 2019-04-12
- First posted
- 2015-01-30
- Last updated
- 2021-06-11
- Results posted
- 2020-04-20
Locations
8 sites across 7 countries: United States, France, Germany, Italy, Netherlands, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT02350816. Inclusion in this directory is not an endorsement.