Liver Disease in Urea Cycle Disorders

NCT04612764 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 62

Last updated 2026-04-27

No results posted yet for this 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.

Conditions

  • Urea Cycle Disorder
  • Ornithine Transcarbamylase Deficiency
  • Citrullinemia 1
  • ARGI Deficiency
  • ASL Deficiency
  • Argininosuccinic Aciduria
  • ASS Deficiency
  • Hyperargininemia

Sponsors & Collaborators

  • Children's National Research Institute

    collaborator OTHER
  • Seattle Children's Hospital

    collaborator OTHER
  • Children's Hospital Colorado

    collaborator OTHER
  • Children's Hospital of Philadelphia

    collaborator OTHER
  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Lindsay Burrage, MD, PhD · Baylor College of Medicine

Eligibility

Min Age
6 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-04
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04612764 on ClinicalTrials.gov