Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study of Hereditary Orotic Aciduria, sponsored by Wellstat Therapeutics.
NCT02110147 is a Phase 3 study of Hereditary Orotic Aciduria that has completed, run by Wellstat Therapeutics. The registered enrollment target is 4 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Hereditary orotic aciduria patients will be taking uridine triacetate as replacement therapy for uridine. The primary outcome measure will be based on predetermined principal hematologic parameter(s) based on the patient's response(s) to oral uridine when dosing is switched from oral uridine to oral uridine triacetate. The primary outcome measure in patients not previously receiving uridine replacement therapy will be improvement in the patient's principal affected hematologic parameter(s) on Da
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 |
What the finished NCT02110147 record still lists
NCT02110147 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02110147's enrollment target sits among peer trials
4 1998th of 2000 higher than 2 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia