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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for not_applicable

Timeline

Completed

Started Jan 2012

Longer than P75 for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3.2 years study duration

Study Start

First participant enrolled

January 1, 2012

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

February 9, 2012

Completed

2 months until next milestone

First Posted

Study publicly available on registry

April 17, 2012

Completed

3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed

6.3 years until next milestone

Results Posted

Study results publicly available

July 15, 2021

Completed

Last Updated

July 15, 2021

Status Verified

June 1, 2021

Enrollment Period

3.2 years

First QC Date

February 9, 2012

Results QC Date

April 30, 2021

Last Update Submit

June 24, 2021

Conditions

Hepatitis C, Chronic Non-Alcoholic Fatty Liver Disease

Keywords

HepatitisFatty Liver

Outcome Measures

Primary Outcomes (1)

Cholate Shunt Test
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.
Average of all three study visits performed within 30 days

Secondary Outcomes (2)

Intra-individual Reproducibility of the Cholate SHUNT Test Across All Subjects
All three study visits within 30 days
Intra-class Reproducibility of the Disease Severity Index (DSI) by Histological Fibrosis Stage
Average of DSIs obtained from all three study visits within 30 days

Study Arms (5)

Healthy Controls

EXPERIMENTAL

Healthy controls will be recruited to have approximately equal numbers of men and women. Controls will be of healthy weight as defined by a BMI 18-25 and without liver disease or risk factors for liver disease.