Intra-Individual Reproducibility of the Non-Invasive Assessment of the Portal Circulation

Completed · Not applicable

Conditions studied: Hepatitis C, Chronic, Non-Alcoholic Fatty Liver Disease

In brief

HepQuant tests are new liver tests that are being developed to accurately measure liver function with sensitivity and specificity while being safe and non-invasive. The primary goal of this study is to define the intra-individual reproducibility of the HepQuant tests, that is, to see if a person is given the tests several times that the test results are essentially the same each time. Subjects for this study will include healthy controls and patients with chronic liver diseases. The chronic liver diseases will include hepatitis C virus (HCV) infection and a serious form of fatty liver disease, known as non-alcoholic steatohepatitis (NASH). The HCV and NASH patients will include men and women, and those with early stage and late stage liver disease as defined by the amount of fibrosis observed in their liver biopsies. Once a subject has been enrolled in the study they will be given the HepQuant tests on three separate days within the span of one month. The hypothesis of this study is that HepQuant tests will reproducibly report liver function in healthy controls and patients with all stages of chronic HCV and NASH liver disease and that liver function will decrease as the amount of liver fibrosis increases in the chronic liver disease patients.

Key facts

Study ID

NCT01579162

Run by

HepQuant, LLC

People needed

48

Starts

2012-01-01

Expected to finish

2015-04-01

Last updated by the study team

2021-07-15

Who can join

Age: 22 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Diagnosis of chronic HCV or NASH
• Liver biopsy within 2 years of enrollment
• Compensated liver disease

You may not qualify if…

• Decompensated liver disease
• Currently being treated with beta blockers, ACE inhibitors, or other agents affecting FMD
• Malignancy diagnosed within 5 years of study enrollment without demonstrated clearance
• History of congestive heart failure
• Renal insufficiency with chronic kidney disease stage 4 or 5 (GFR < 30 mL/min/1.73m2)
• Crohn's disease or any active intestinal inflammatory condition
• Having an ileal resection
• Diabetic Gastroparesis
• Pregnancy or intent to become pregnant. Urine pregnancy tests will be performed at each visit.
• Inability to consent for one's self

Where it is running

• University of Colorado Hospital — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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