CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 48 enrolled
Drug / intervention
Cholate-24-13C (IND 65121) & Cholate-2,2,4,4-d4 (IND 65123)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01579162
NCT01579162N/ACompleted

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

HepQuant, LLC·interventional·Posted Apr 17, 2012·Updated Jul 15, 2021

In Brief

A clinical study evaluating Cholate-24-13C (IND 65121) & Cholate-2,2,4,4-d4 (IND 65123) for Hepatitis C, Chronic and Non-Alcoholic Fatty Liver Disease. Completed, enrolled 48 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 17, 2012
Enrollment StartJan 1, 2012
Primary CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 14.2 years ago

Interventions

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