HepQuant Begins Its First Clinical Study
A New Clinical Study
A new clinical study has been initiated to study the reproducibility of HepQuant testing and the ability of testing to measure liver function in healthy controls and patients with chronic liver disease. Patients will have either chronic HCV or a serious form of fatty liver disease, known as non-alcoholic steatohepatitis (NASH). This is the first clinical study to be carried out with HepQuant as the primary sponsor.
Study Title
Intra-Individual Reproducibility of the Non-Invasive Assessment of the Portal Circulation
Hypothesis
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 correlate with the histological assessment of liver fibrosis.
Specific Aims
1. To define the reproducibility of the HepQuant tests in healthy control individuals (n=8), chronic HCV patients with moderate fibrosis (n=8), chronic HCV patients with extensive fibrosis (n=8), NASH patients with moderate fibrosis (n=8), and NASH patients with extensive fibrosis (n=8), by comparison of the test results from three studies performed within 30 days.
2. In HCV and NASH patients, to correlate the HepQuant test results with the histological assessment of liver fibrosis from biopsies done within 2 years of enrollment.
Study Subjects
Patients with chronic HCV infection or NASH will be recruited from the Hepatology Clinics of the University of Colorado Hospital (UCH). Inclusion criteria will include having had a liver biopsy within the last 2 years. Healthy control individuals will be recruited from the general population of the Denver metropolitan area. Previously it was observed that some people who were apparently healthy by standard liver tests but who were overweight or obese had lower liver function by HepQuant testing. It is possible that HepQuant testing had detected undiagnosed fatty liver disease. Therefore only healthy individuals of normal weight, defined as BMI 18-25, will be recruited as controls. All subjects, patients and healthy controls will be paid as partial compensation for their time. Subjects will be paid $20 for the 1st visit, $30 for the 2nd visit, and $40 for the 3rd visit, to encourage the subjects to come for all 3 testing visits.
Study Procedures
Subjects will be asked to fast overnight and report to the UCH Clinical Translational Research Center (CTRC). An intravenous catheter will be placed in the subjects arm for the infusion of the 1st test compound. A 2nd test compound will be dissolved in water and juice for the subject to drink at the same time as the infusion. Small blood samples will then be drawn through the catheter at 5, 20, 45, 60, and 90 minutes later. The subject can then leave and return to work or home. The blood samples will be analyzed for the test compounds to calculate the liver function HepQuant test results.
