Intra-Individual Reproducibility of the Non-Invasive Assessment of the Portal Circulation
This study is currently recruiting participants.
Verified January 2013 by HepQuant, LLC
Sponsor:
HepQuant, LLC
Information provided by (Responsible Party):
HepQuant, LLC
ClinicalTrials.gov Identifier:
NCT01579162
First received: February 9, 2012
Last updated: January 22, 2013
Last verified: January 2013
| Tracking Information | |||||||||
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| First Received Date ICMJE | February 9, 2012 | ||||||||
| Last Updated Date | January 22, 2013 | ||||||||
| Start Date ICMJE | January 2012 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Cholate Shunt Test [ Time Frame: 9 months ] [ Designated as safety issue: No ] The Cholate Shunt Test result is defined as the ratio of the IV Cholate Clearance Test result to the Oral Cholate Clearance Test result and is expressed as a percentage. The IV Cholate Clearance Test result = (dose cholate-24-13C/AUC cholate-24-13C)/subject weight and is expressed as mL/min/kg. The Oral Cholate Clearance Test result = (dose cholate-2,2,4,4-d4/AUC cholate-2,2,4,4-d4)/subject weight and is expressed as mL/min/kg. The AUC cholate-24-13C and AUC cholate-2,2,4,4-d4 are calculated from LCMS analysis of serum samples collected at 0, 5, 20, 45, 60, 90 minutes post-dose. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01579162 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Intra-Individual Reproducibility of the Non-Invasive Assessment of the Portal Circulation | ||||||||
| Official Title ICMJE | Intra-Individual Reproducibility of the Non-Invasive Assessment of the Portal Circulation | ||||||||
| Brief 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE |
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| Intervention ICMJE | Device: 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 Other Names:
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 40 | ||||||||
| Estimated Completion Date | December 2013 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 22 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01579162 | ||||||||
| Other Study ID Numbers ICMJE | HepQuant-001 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | HepQuant, LLC | ||||||||
| Study Sponsor ICMJE | HepQuant, LLC | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | HepQuant, LLC | ||||||||
| Verification Date | January 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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