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NCT01579162 · ClinicalTrials.gov registry record · NA
Intra-Individual Reproducibility of the Non-Invasive Assessment of the Portal Circulation
A NA study of Non-alcoholic Fatty Liver Disease and Hepatitis C, Chronic, sponsored by HepQuant.
- Completed
- Registry status
- NA
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT01579162: Completed NA study of Non-alcoholic Fatty Liver Disease and Hepatitis C, Chronic, sponsored by HepQuant.
NCT01579162 is a NA study of Non-alcoholic Fatty Liver Disease and Hepatitis C, Chronic that has completed, run by HepQuant. The registered enrollment target is 48 participants, below the 176-participant average among 57 other Non-alcoholic Fatty Liver Disease trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01579162, a NA study of Non-alcoholic Fatty Liver Disease and Hepatitis C, Chronic, has completed, sponsored by HepQuant.
- COMPLETED
- Registry status
- NA
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The Cholate Shunt Test result is defined as the ratio of the IV Cholate Clearance to the Oral Cholate Clearance and is expressed as a percentage. The higher the SHUNT percentage, the more the blood flow is shunting around the liver, the more severe the liver disease. The average of the SHUNT test results (ratio of IV Cholate Clearance to Oral Cholate Clearance) from all three time points (3 visits within 30 days) for each participant was used in the calculation of the group SHUNT Test results.
Conditions Studied
Interventions
- DEVICE Cholate-24-13C (IND 65121) & Cholate-2,2,4,4-d4 (IND 65123)
Study Locations (1)
Colorado
- University of Colorado Hospital - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2012-01 |
| Est. Completion | 2015-04 |
| Phase | NA |
What the finished NCT01579162 record still lists
NCT01579162 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 176-participant average among 57 other Non-alcoholic Fatty Liver Disease trials with a reported enrollment target (73% lower).
The record links to 2 conditions, with Non-alcoholic Fatty Liver Disease appearing as the primary indexed condition, and to 1 intervention - of which Cholate-24-13C (IND 65121) & Cholate-2,2,4,4-d4 (IND 65123) is the first listed.
NCT01579162 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT01579162 about?
NCT01579162 is a clinical study titled "Intra-Individual Reproducibility of the Non-Invasive Assessment of the Portal Circulation". 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 ...
What is the current status of trial NCT01579162?
This trial is currently completed. It is a NA study. The enrollment target is 48 participants. The study started on 2012-01. Estimated completion is 2015-04.
What conditions does trial NCT01579162 study?
This clinical trial studies the following conditions: Non-alcoholic Fatty Liver Disease, Hepatitis C, Chronic.
What interventions are being tested in trial NCT01579162?
The interventions under investigation include: Cholate-24-13C (IND 65121) & Cholate-2,2,4,4-d4 (IND 65123) (DEVICE).
Who is sponsoring clinical trial NCT01579162?
This trial is sponsored by HepQuant, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01579162 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT01579162's enrollment target sits among peer trials
48 35th of 57 higher than 22 of 57 other Non-alcoholic Fatty Liver Disease trials
participants (enrollment target), bucketed by value
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