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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2015-04-30

Brief Summary

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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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Detailed Description

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Conditions

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Hepatitis C, Chronic Non-Alcoholic Fatty Liver Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Healthy Controls

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.

Group Type EXPERIMENTAL

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

Intervention Type 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

chronic HCV patients with F0-F2 fibrosis

Group Type EXPERIMENTAL

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

Intervention Type 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

chronic HCV patients with F3-F4 fibrosis

Group Type EXPERIMENTAL

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

Intervention Type 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

NASH patients with F0-F2 fibrosis

Group Type EXPERIMENTAL

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

Intervention Type 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

NASH patients with F3-F4 fibrosis

Group Type EXPERIMENTAL

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

Intervention Type 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

Interventions

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

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

Intervention Type DEVICE

Other Intervention Names

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Cholic acid-24-13C Cholic acid-2,2,4,4-d4

Eligibility Criteria

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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

Minimum Eligible Age

22 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes