CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 187 enrolled
Drug / intervention
No Intervention Givenother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02740153
NCT02740153N/ACompleted

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

Children's National Research Institute·observational·Posted Apr 15, 2016·Updated Jan 26, 2021

In Brief

An observational study evaluating No Intervention Given for Urea Cycle Disorders. Completed, enrolled 187 participants across 1 site.

Detailed 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.

Study Details

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 15, 2016
Enrollment StartMar 4, 2016
Primary CompletionJun 10, 2019
Study CompletionJun 30, 2020
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 10.2 years ago

Interventions

No Intervention Givenother