Overview

This trial is active, not recruiting.

Conditions hepatitis c, chronic, non-alcoholic fatty liver disease
Treatment cholate-24-13c (ind 65121) & cholate-2,2,4,4-d4 (ind 65123)
Sponsor HepQuant, LLC
Start date January 2012
End date June 2016
Trial size 40 participants
Trial identifier NCT01579162, HepQuant-001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
Arm
(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.
cholate-24-13c (ind 65121) & cholate-2,2,4,4-d4 (ind 65123) Cholic acid-24-13C
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
(Experimental)
cholate-24-13c (ind 65121) & cholate-2,2,4,4-d4 (ind 65123) Cholic acid-24-13C
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
(Experimental)
cholate-24-13c (ind 65121) & cholate-2,2,4,4-d4 (ind 65123) Cholic acid-24-13C
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
(Experimental)
cholate-24-13c (ind 65121) & cholate-2,2,4,4-d4 (ind 65123) Cholic acid-24-13C
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
(Experimental)
cholate-24-13c (ind 65121) & cholate-2,2,4,4-d4 (ind 65123) Cholic acid-24-13C
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

Primary Outcomes

Measure
Cholate Shunt Test
time frame: 9 months

Secondary Outcomes

Measure
Intra-individual Reproducibility of the Cholate Tests
time frame: 9 months
Correlation of Cholate Tests with Histological Fibrosis Stage
time frame: 9 months

Eligibility Criteria

Male or female participants from 22 years up to 65 years old.

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

Additional Information

Official title Intra-Individual Reproducibility of the Non-Invasive Assessment of the Portal Circulation
Principal investigator James R Burton, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by HepQuant, LLC.