Hepatic Histopathology in Urea Cycle Disorders

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Baylor College of Medicine
Study ID
NCT04908319
Status
Recruiting
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Conditions

  • ARGI Deficiency
  • ASL Deficiency
  • ASS Deficiency
  • Argininosuccinic Aciduria
  • Carbamyl Phosphate Synthetase Deficiency
  • Citrullinemia 1
  • Hyperargininemia
  • NAGS Deficiency
  • Ornithine Transcarbamylase Deficiency
  • Urea Cycle Disorder

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Feb 24, 2022
Status verified
Jul 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
70 participants (estimated)

Primary Outcome Measure

Hepatic fibrosis [ Time Frame: Day 1 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Children's National Medical CenterWashington D.C.District of Columbia20010
Kara Simpson, MS, CGC
[email protected]
202-476-6216
Nicholas A Mew, MD (PRINCIPAL_INVESTIGATOR)
Baylor College of MedicineHoustonTexas77030
Saima Ali
[email protected]
832-822-4183
Lindsay Burrage, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
Children's National Medical Center· Washington D.C., DCBaylor College of Medicine· Houston, TX

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