Open-Label Study of Uridine Triacetate in Pediatric Patients With Hereditary Orotic Aciduria
Completed · Phase 3
Conditions studied: Hereditary Orotic Aciduria
In brief
This protocol has two parts - the Main Study which is 42 days in length and the Treatment Extension which allows the patients who complete the Main Study to continue receiving treatment with uridine triacetate. The purpose of this study is to replace oral administration of uridine with oral administration of uridine triacetate in patients with hereditary orotic aciduria who have received (or would reasonably be expected to receive) clinical benefit from treatment with exogenous uridine. It is also to document the continued clinical benefit of exogenous uridine when patients are switched from oral administration of uridine to oral administration of uridine triacetate.
Key facts
- Study ID
- NCT02110147
- Run by
- Wellstat Therapeutics
- People needed
- 4
- Starts
- 2014-04-01
- Expected to finish
- 2016-09-08
- Last updated by the study team
- 2017-07-31
Who can join
Age: 1 and older, up to 19. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Children's Hospital of Michigan - Specialty Center Detroit — Detroit, Michigan, United States
- Children's Hospital of Pittsburgh of UPMC — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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