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NCT04908319 · ClinicalTrials.gov registry record
Hepatic Histopathology in Urea Cycle Disorders
A clinical trial of Urea Cycle Disorder and Ornithine Transcarbamylase Deficiency, sponsored by Baylor College of Medicine.
- Recruiting
- Registry status
- 70
- Enrollment target
- 2
- Study locations
NCT04908319: Recruiting study of Urea Cycle Disorder and Ornithine Transcarbamylase Deficiency, sponsored by Baylor College of Medicine.
NCT04908319 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 70 participants, above the 32-participant average among 4 other Urea Cycle Disorder trials with a reported enrollment target (119% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04908319, a study of Urea Cycle Disorder and Ornithine Transcarbamylase Deficiency, is actively recruiting participants, sponsored by Baylor College of Medicine.
- RECRUITING
- Registry status
- 70 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a multi-site, retrospective chart review as well as a prospective study to evaluate histopathologic findings in liver samples from individuals with any UCD diagnosis. This study will be conducted at all Urea Cycle Disorders Consortium (UCDC) sites: Baylor College of Medicine in Houston, TX and Children's National Medical Center in Washington D.C.
Primary Outcome
Staging of fibrosis from histopathology report from the liver biopsy or explant
Conditions Studied
Study Locations (2)
District of Columbia
- Children's National Medical Center - Washington D.C.
Texas
- Baylor College of Medicine - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2022-02-24 |
| Est. Completion | 2026-06-30 |
What NCT04908319 shows while recruiting
NCT04908319 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 70 participants, a relatively small participant target, above the 32-participant average among 4 other Urea Cycle Disorder trials with a reported enrollment target (119% higher).
The record links to 10 conditions, with Urea Cycle Disorder appearing as the primary indexed condition, and to 0 interventions.
NCT04908319 reports a single indexed study location in District of Columbia, Texas.
Frequently Asked Questions
What is clinical trial NCT04908319 about?
NCT04908319 is a clinical study titled "Hepatic Histopathology in Urea Cycle Disorders". This is a multi-site, retrospective chart review as well as a prospective study to evaluate histopathologic findings in liver samples from individuals with any UCD diagnosis. This study will be conducted at all Urea Cycle Disorders Consortium (UCDC) sites: Baylor College of Medicine in Houston, TX a...
What is the current status of trial NCT04908319?
This trial is currently recruiting. The enrollment target is 70 participants. The study started on 2022-02-24. Estimated completion is 2026-06-30.
What conditions does trial NCT04908319 study?
This clinical trial studies the following conditions: Urea Cycle Disorder, Ornithine Transcarbamylase Deficiency, Argininosuccinic Aciduria, Hyperargininemia, Citrullinemia 1.
Who is sponsoring clinical trial NCT04908319?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04908319 being conducted?
This trial has 2 study locations across District of Columbia, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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