Trials / Terminated
TerminatedNCT02599961
Study to Assess the Long Term Safety and Efficacy of UX007 in Participants With Glucose Type 1 Deficiency Syndrome (Glut1 DS)
An Open-label Extension Study to Assess the Long-term Safety and Efficacy of UX007 in Subjects With Glucose Transporter Type 1 Deficiency Syndrome
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Ultragenyx Pharmaceutical Inc · Industry
- Sex
- All
- Age
- 1 Year
- Healthy volunteers
- Not accepted
Summary
The primary objective of the study is to evaluate the long-term safety of UX007 in Glut1 DS participants.
Detailed description
The study will enroll up to 40 pediatric, adolescent and adult Glut 1 DS participants who have completed the UX007G-CL201 (NCT019933186) study and, at the discretion of the Sponsor, additional participants from other clinical studies, investigator sponsored trials (ISTs), or expanded access/compassionate use treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | UX007 | UX007 is a liquid intended for oral (PO) administration. |
Timeline
- Start date
- 2015-09-10
- Primary completion
- 2019-10-22
- Completion
- 2019-10-22
- First posted
- 2015-11-09
- Last updated
- 2020-06-11
- Results posted
- 2020-04-30
Locations
9 sites across 5 countries: United States, Australia, Denmark, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT02599961. Inclusion in this directory is not an endorsement.