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Completed No phase listed Observational Accepts healthy volunteers Results available

PCORI Urea Cycle Disorder Study

ClinicalTrials.gov ID: NCT02740153

Public ClinicalTrials.gov record NCT02740153. 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 17, 2026, 12:55 PM EDT

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

Official title

Comparative Effectiveness of Therapy in Rare Diseases: Liver Transplantation vs. Conservative Management of Urea Cycle Disorders

Brief summary

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

Urea cycle disorders (UCD) are genetic disorders caused by the liver's inability to break down ammonia from proteins; ammonia then accumulates and is toxic to the brain. UCD cause brain damage and intellectual and developmental disabilities and even death. Treatment for UCD is either conservative management which involves a low-in-protein diet, drugs, and amino acid supplements or liver transplantation; each carries their own risks. This study aims to help patients to make the decision about different management alternatives by providing them with scientific information that is currently lacking. Aim 1 of this study will compare survival, neurocognitive function, and patient-reported quality of life.

Study identification

NCT ID
NCT02740153
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Enrollment
187 participants

Conditions and interventions

Interventions

Other

Eligibility (public fields only)

Age range
Up to 18 Years
Sex
All
Healthy volunteers
Accepts healthy volunteers

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

Study timeline

Start date
Mar 3, 2016
Primary completion
Jun 9, 2019
Completion
Jun 29, 2020
Last update posted
Jan 25, 2021

2016 – 2020

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Childrens Research Institute Washington D.C. District of Columbia 20010

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 NCT02740153, 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 Jan 25, 2021 · Synced Sep 17, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02740153 live on ClinicalTrials.gov.

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