Noninvasive Biomarkers of Hepatic Fibrosis in Urea Cycle Disorders
Status: Active_not_recruiting
Location: See all (5) locations...
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 65
Healthy Volunteers: f
View:
• Age \> 6 years and \< 65 years
• Weight ≥ 11 kg at time of screening
• A molecular or biochemical diagnosis of OTCD, ASS1D, ASLD, or ARG1D.
Locations
United States
Colorado
Children's Hospital Colorado
Aurora
Washington, D.c.
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
Time Frame
Start Date: 2021-11-04
Completion Date: 2026-12-31
Participants
Target number of participants: 62
Authors
Related Therapeutic Areas
Sponsors
Collaborators: Children's National Research Institute, Children's Hospital Colorado, Seattle Children's Hospital, Children's Hospital of Philadelphia
Leads: Baylor College of Medicine