Clinical trial NCT01579162: Intra-Individual Reproducibility of the Non-Invasive Assessment of the Portal Circulation
Official title: Intra-Individual Reproducibility of the Non-Invasive Assessment of the Portal Circulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C, Chronic
Non-Alcoholic Fatty Liver Disease
Keywords: Hepatitis
Fatty Liver
Lead sponsor: HepQuant, LLC
Sponsor class: INDUSTRY
First posted: 2012-04-17
Enrollment: 48
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Cholate Shunt Test
timeFrame: Average of all three study visits performed within 30 days
Secondary outcomes:
measure: Intra-individual Reproducibility of the Cholate SHUNT Test Across All Subjects
timeFrame: All three study visits within 30 days
measure: Intra-class Reproducibility of the Disease Severity Index (DSI) by Histological Fibrosis Stage
timeFrame: Average of DSIs obtained from all three study visits within 30 days
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado School of Medicine
name: James R Burton, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Everson GT, Shiffman ML, Hoefs JC, Morgan TR, Sterling RK, Wagner DA, Lauriski S, Curto TM, Stoddard A, Wright EC; HALT-C Trial Group. Quantitative liver function tests improve the prediction of clinical outcomes in chronic hepatitis C: results from the Hepatitis C Antiviral Long-term Treatment Against Cirrhosis Trial. Hepatology. 2012 Apr;55(4):1019-29. doi: 10.1002/hep.24752. Epub 2012 Mar 1.
citation: Everson GT, Shiffman ML, Hoefs JC, Morgan TR, Sterling RK, Wagner DA, Desanto JL, Curto TM, Wright EC; HALT-C Trial Group. Quantitative tests of liver function measure hepatic improvement after sustained virological response: results from the HALT-C trial. Aliment Pharmacol Ther. 2009 Mar 1;29(5):589-601. doi: 10.1111/j.1365-2036.2008.03908.x. Epub 2008 Dec 1.
citation: Everson GT, Shiffman ML, Morgan TR, Hoefs JC, Sterling RK, Wagner DA, Kulig CC, Curto TM, Wright EC; Halt-C Trial Group. The spectrum of hepatic functional impairment in compensated chronic hepatitis C: results from the Hepatitis C Anti-viral Long-term Treatment against Cirrhosis Trial. Aliment Pharmacol Ther. 2008 May;27(9):798-809. doi: 10.1111/j.1365-2036.2008.03639.x. Epub 2008 Feb 7.
citation: Everson GT, Martucci MA, Shiffman ML, Sterling RK, Morgan TR, Hoefs JC; HALT-C trial group. Portal-systemic shunting in patients with fibrosis or cirrhosis due to chronic hepatitis C: the minimal model for measuring cholate clearances and shunt. Aliment Pharmacol Ther. 2007 Aug 1;26(3):401-10. doi: 10.1111/j.1365-2036.2007.03389.x.