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

HepQuant

Status: Completed

Conditions: Hepatitis C, Chronic; Non-Alcoholic Fatty Liver Disease

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01579162

HepQuant-001

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 22 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 5 patient groups

Healthy Controls

Experimental group

Description:

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.

Treatment:

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

chronic HCV patients with F0-F2 fibrosis

Experimental group

Treatment:

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

chronic HCV patients with F3-F4 fibrosis

Experimental group

Treatment:

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

NASH patients with F0-F2 fibrosis

Experimental group

Treatment:

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

NASH patients with F3-F4 fibrosis

Experimental group

Treatment:

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