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

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.

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Key information

Conditions

Hepatitis C, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Fatty Liver Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Non-Alcoholic Fatty Liver Disease Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

22 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholate-24-13C (IND 65121) & Cholate-2,2,4,4-d4 (IND 65123)

Device

The FDA has indicated that liver function diagnostic testing with stable isotope labeled cholates would be considered a drug/device combination product. The drugs administered at each test visit will be:

20 mg Cholate-24-13C, IV (in the vein), dissolved in NaHCO3 and mixed with albumin.

40 mg Cholate-2,2,4,4-d4, oral, dissolved in NaHCO3 and mixed with juice.

The 3 test visits will be on separate days within a span of 30 days

Other names: Cholic acid-24-13C, Cholic acid-2,2,4,4-d4

Primary outcomes

Cholate Shunt Test

Time frame: Average of all three study visits performed within 30 days

The Cholate Shunt Test result is defined as the ratio of the IV Cholate Clearance to the Oral Cholate Clearance and is expressed as a percentage. The higher the SHUNT percentage, the more the blood flow is shunting around the liver, the more severe the liver disease.

The average of the SHUNT test results (ratio of IV Cholate Clearance to Oral Cholate Clearance) from all three time points (3 visits within 30 days) for each participant was used in the calculation of the group SHUNT Test results.

Secondary outcomes

Intra-individual Reproducibility of the Cholate SHUNT Test Across All Subjects

Time frame: All three study visits within 30 days

The intra-individual reproducibility of the Cholate Shunt Test (SHUNT %), will be defined by its average Coefficient of Variation (CV) and its Intra-Class Correlation (ICC). Each subject will be tested at baseline and then twice more on separate days within the span of one month. The CV of each subject's three replicate tests will be used to calculate the average CV for each type of test. All test results for each type of test will be used to calculate its ICC.
Intra-class Reproducibility of the Disease Severity Index (DSI) by Histological Fibrosis Stage

Time frame: Average of DSIs obtained from all three study visits within 30 days

The intra-class correlation coefficients (ICCs) for reproducibility of the Disease Severity Index (DSI, an index value measuring severity of liver disease that can be calculated using the SHUNT Test results) were obtained by stage of liver fibrosis by liver biopsy.

The DSI is a score on a scale from 0 (healthy) to 50 (severe liver disease), so the higher the DSI, the more severe the liver disease. Fibrosis scores increase with disease severity as well, so subjects with F0-F2 fibrosis have less severe liver disease than subjects with F3-F4 fibrosis.

Sponsors and collaborators

Lead sponsor

HepQuant, LLC

Industry

Registry information

Acronym: Repro

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2015
First posted: Apr 17, 2012
Registry last updated: Jul 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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