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NCT02740153 · ClinicalTrials.gov registry record
PCORI Urea Cycle Disorder Study
A clinical trial, sponsored by Children's National Research Institute.
- Completed
- Registry status
- 187
- Enrollment target
NCT02740153: Completed study, sponsored by Children's National Research Institute.
NCT02740153 is a clinical trial that has completed, run by Children's National Research Institute. The registered enrollment target is 187 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02740153 has completed, sponsored by Children's National Research Institute.
- COMPLETED
- Registry status
- 187 participants
- Enrollment target
Study Summary
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.
Primary Outcome
This aspect of Aim 1 is prospective by design based on selection by exposure (liver transplant or medical managed) evaluating the clinical outcomes of subjects with urea cycle disorders.
Interventions
- OTHER No Intervention Given
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 187 participants |
| Start Date | 2016-03-04 |
| Est. Completion | 2020-06-30 |
What the finished NCT02740153 record still lists
NCT02740153 is an observational study that tracks outcomes without assigning an intervention. The registered 187 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which No Intervention Given is the first listed.
NCT02740153 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02740153 about?
NCT02740153 is a clinical study titled "PCORI Urea Cycle Disorder Study". 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 m...
What is the current status of trial NCT02740153?
This trial is currently completed. The enrollment target is 187 participants. The study started on 2016-03-04. Estimated completion is 2020-06-30.
What interventions are being tested in trial NCT02740153?
The interventions under investigation include: No Intervention Given (OTHER).
Who is sponsoring clinical trial NCT02740153?
This trial is sponsored by Children's National Research Institute, which has 92 total clinical trials registered on ClinicalTrials.gov.
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