Prevalence of Liver Disease in Patients Dependent on Parenteral Nutrition

Completed

Conditions studied: Intestinal Failure-associated Liver Disease

In brief

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).

Key facts

Study ID

NCT05011370

Run by

Protara Therapeutics

People needed

80

Starts

2021-08-23

Expected to finish

2023-06-29

Last updated by the study team

2023-10-03

Who can join

Age: 12 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The participant and/or their parent/Legally Authorized Representative is willing and able to provide signed informed consent or assent as appropriate
• Male or female adults 18 to 80 years of age, or adolescents 12 to 17 years of age
• Patients dependent on parenteral nutrition (PN) that receive PN for an average ≥ 4 days a week for 10 weeks or longer prior to screening to meet nutritional, caloric, fluid, and/or electrolyte needs
• The Investigator expects no changes in the lipid, dextrose, amino acid, or vitamin regimen to be medically necessary during the participant's participation in the study
• Willingness of participant to maintain his/her current habitual oral diet and fluids regimen for the study duration

You may not qualify if…

• Participants taking steatogenic medications for ≥12 weeks in the past 12 months (e.g., amiodarone, tamoxifen, methotrexate, tetracycline, glucocorticoids, anabolic steroids, over the usual dose of estrogen for hormone replacement therapy, and valproate); those taking any medicine (e.g., metformin, thiazolidinediones, ursodeoxycholic acid, pentoxifylline, S-adenosyl-L-Methionine, and betaine) that could affect the measurement of IFALD within 12 weeks prior to study entry
• Participants taking potential hepatotoxic medications that in the judgement of the Investigator is causing hepatic abnormalities
• Participants with a cardiac pacemaker, intravascular stents, other metallic devices, and claustrophobia which are contraindicated to magnetic resonance imaging
• Participants who took choline supplements or choline-containing multivitamins within 14 days of screening
• History of major organ transplant (e.g., heart, kidney, liver, etc.)
• For more information on eligibility criteria, please contact the sponsor.

Where it is running

• Ronald Reagan Medical Center of UCLA — Los Angeles, California, United States
• IHS Health — Kissimmee, Florida, United States
• The University of Chicago — Chicago, Illinois, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Cincinnati Children's Hospital — Cincinnati, Ohio, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• Seattle Children's — Seattle, Washington, United States
• Rigshospitalet — Copenhagen, Denmark
• Center for Chronic Intestinal Failure, St. Orsola Hospital Dept of Medical and Surgical Sciences, University of Bologna — Bologna, Italy
• St. Mark's Hospital — Harrow, England, United Kingdom
• University College London Hospitals — London, England, United Kingdom
• Northern Care Alliance NHS Foundation — Salford, England, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.