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Completed Phase 3 Interventional Results available

Open-Label Study of Uridine Triacetate in Pediatric Patients With Hereditary Orotic Aciduria

ClinicalTrials.gov ID: NCT02110147

Public ClinicalTrials.gov record NCT02110147. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 12, 2026, 2:18 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT02110147
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Wellstat Therapeutics
Industry
Enrollment
4 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
6 Months to 19 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 31, 2014
Primary completion
Nov 30, 2014
Completion
Sep 7, 2016
Last update posted
Jul 30, 2017

2014 – 2016

United States locations

U.S. sites
2
U.S. states
2
U.S. cities
2
Facility City State ZIP Site status
Children's Hospital of Michigan - Specialty Center Detroit Detroit Michigan 48201
Children's Hospital of Pittsburgh of UPMC Pittsburgh Pennsylvania 15224

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02110147, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 30, 2017 · Synced Sep 12, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02110147 live on ClinicalTrials.gov.

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