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NCT04612764 · ClinicalTrials.gov registry record
Liver Disease in Urea Cycle Disorders
A clinical trial of Urea Cycle Disorder and Ornithine Transcarbamylase Deficiency, sponsored by Baylor College of Medicine.
- Recruiting
- Registry status
- 62
- Enrollment target
- 5
- Study locations
NCT04612764: Recruiting study of Urea Cycle Disorder and Ornithine Transcarbamylase Deficiency, sponsored by Baylor College of Medicine.
NCT04612764 is a study of Urea Cycle Disorder and Ornithine Transcarbamylase Deficiency that is actively recruiting participants, run by Baylor College of Medicine. The registered enrollment target is 62 participants, above the 34-participant average among 4 other Urea Cycle Disorder trials with a reported enrollment target (82% higher). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04612764, a study of Urea Cycle Disorder and Ornithine Transcarbamylase Deficiency, is actively recruiting participants, sponsored by Baylor College of Medicine.
- RECRUITING
- Registry status
- 62 participants
- Enrollment target
- 5
- Study locations
Study Summary
This is a multi-center, cross-sectional study to assess risk for liver fibrosis and hepatic injury in individuals with urea cycle disorders (UCDs) using serum biomarkers, Fibroscan, and MRE. This study will be conducted at 5 sites of the Urea Cycle Disorders Consortium: Baylor College of Medicine in Houston, TX, Seattle Children's Hospital in Seattle, WA, Children's Hospital Colorado in Aurora, CO, Children's Hospital of Philadelphia in Philadelphia, PA, and Children's National Medical Center in Washington D.C.
Primary Outcome
Fibrotest(TM)
Conditions Studied
Study Locations (5)
Colorado
- Children's Hospital Colorado - Aurora
District of Columbia
- Children's National Medical Center - Washington D.C.
Pennsylvania
- The Children's Hospital of Philadelphia - Philadelphia
Texas
- Baylor College of Medicine - Houston
Washington
- Seattle Children's Hospital - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2021-11-04 |
| Est. Completion | 2025-12-31 |
What NCT04612764 shows while recruiting
NCT04612764 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 62 participants, a relatively small participant target, above the 34-participant average among 4 other Urea Cycle Disorder trials with a reported enrollment target (82% higher).
The record links to 8 conditions, with Urea Cycle Disorder appearing as the primary indexed condition, and to 0 interventions.
NCT04612764 lists 5 locations in 5 states (Colorado, District of Columbia, Pennsylvania).
Frequently Asked Questions
What is clinical trial NCT04612764 about?
NCT04612764 is a clinical study titled "Liver Disease in Urea Cycle Disorders". This is a multi-center, cross-sectional study to assess risk for liver fibrosis and hepatic injury in individuals with urea cycle disorders (UCDs) using serum biomarkers, Fibroscan, and MRE. This study will be conducted at 5 sites of the Urea Cycle Disorders Consortium: Baylor College of Medicine in...
What is the current status of trial NCT04612764?
This trial is currently recruiting. The enrollment target is 62 participants. The study started on 2021-11-04. Estimated completion is 2025-12-31.
What conditions does trial NCT04612764 study?
This clinical trial studies the following conditions: Urea Cycle Disorder, Ornithine Transcarbamylase Deficiency, Argininosuccinic Aciduria, Hyperargininemia, Citrullinemia 1.
Who is sponsoring clinical trial NCT04612764?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04612764 being conducted?
This trial has 5 study locations across Colorado, District of Columbia, Pennsylvania, Texas, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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