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Prevalence of Liver Disease in Patients Dependent on Parenteral Nutrition

NCT05011370 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2023-10-03

No results posted yet for this study

Summary

This is a multi-center prospective cross-sectional observational study that will assess the prevalence of liver disease in patients dependent on parenteral nutrition (PN) for 4 or more days per week. Liver disease will be determined by the presence of choline deficiency, cholestasis (confirmed by elevated serum alkaline phosphatase (ALP) liver isoenzyme level), and steatosis (confirmed by magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF).

The objective of this study is to investigate the presence/prevalence of liver disease in patients dependent on PN (≥4 days a week).

Conditions

  • Intestinal Failure-associated Liver Disease

Sponsors & Collaborators

  • Protara Therapeutics

    lead INDUSTRY

Principal Investigators

  • Chief Scientific Operations Officer · Protara Therapeutics

Eligibility

Min Age
12 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-23
Primary Completion
2023-06-29
Completion
2023-06-29

Countries

  • United States
  • Denmark
  • Italy
  • United Kingdom

Study Locations

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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 NCT05011370 on ClinicalTrials.gov