Trials / Completed
CompletedNCT02597114
Extension Study of AGT-181-102 to Evaluate Long Term Safety and Activity of AGT-181
An Extension Study of AGT-181-102 Evaluating Safety and Glycosaminoglycans (GAGs) in Adult Patients With Hurler-Scheie or Scheie Syndrome Who Have Completed 8-Weeks of Dosing With AGT-181 in Study AGT-181-102
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- ArmaGen, Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
AGT-181 is a fusion protein containing alpha-L-Iduronidase that is intended to deliver the enzyme peripherally and to the brain, when administered intravenously. This study is an extension of a safety and dose ranging study to obtain long term safety and exposure data, as well as information on the biological activity of the investigational drug
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AGT-181 | intravenous infusion over 3-4 hours |
Timeline
- Start date
- 2015-11-01
- Primary completion
- 2018-03-19
- Completion
- 2018-08-02
- First posted
- 2015-11-05
- Last updated
- 2018-09-25
Source: ClinicalTrials.gov record NCT02597114. Inclusion in this directory is not an endorsement.