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NCT02110147 · ClinicalTrials.gov registry record · Phase 3
Open-Label Study of Uridine Triacetate in Pediatric Patients With Hereditary Orotic Aciduria
A Phase 3 study of Hereditary Orotic Aciduria, sponsored by Wellstat Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 4
- Enrollment target
- 2
- Study locations
NCT02110147 is a Phase 3 study of Hereditary Orotic Aciduria that has completed, run by Wellstat Therapeutics. The registered enrollment target is 4 participants. The trial reports 2 study locations across 2 states.
The verdict
NCT02110147, a Phase 3 study of Hereditary Orotic Aciduria, has completed, sponsored by Wellstat Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 4 participants
- Enrollment target
- 2
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG uridine triacetate
Study Locations (2)
Michigan
- Children's Hospital of Michigan - Specialty Center Detroit - Detroit
Pennsylvania
- Children's Hospital of Pittsburgh of UPMC - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2014-04 |
| Est. Completion | 2016-09-08 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02110147
The ClinicalTrials.gov registry entry for NCT02110147 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wellstat Therapeutics, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hereditary Orotic Aciduria appearing as the primary indexed condition, and to 1 intervention - of which uridine triacetate is the first listed.
NCT02110147 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Michigan, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02110147 about?
NCT02110147 is a clinical study titled "Open-Label Study of Uridine Triacetate in Pediatric Patients With Hereditary Orotic Aciduria". 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 administ...
What is the current status of trial NCT02110147?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 4 participants. The study started on 2014-04. Estimated completion is 2016-09-08.
What conditions does trial NCT02110147 study?
This clinical trial studies the following conditions: Hereditary Orotic Aciduria.
What interventions are being tested in trial NCT02110147?
The interventions under investigation include: uridine triacetate (DRUG).
Who is sponsoring clinical trial NCT02110147?
This trial is sponsored by Wellstat Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02110147 being conducted?
This trial has 2 study locations across Michigan, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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