Clinical Study of the BreathID® System to Train the Algorithm for the ¹³C-Octanoate Breath Test With or Without the ¹³C-Methacetin Breath Test (OBT and MBT Respectively) for Correlation With Histological Findings Associated With Non-Alcoholic Steatohepatitis (NASH) and Other Liver Diseases
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Non-Alcoholic Steatohepatitis
- Sponsor
- Meridian Bioscience, Inc.
- Enrollment
- 140
- Locations
- 11
- Primary Endpoint
- Number of Participants With Biopsy Proven Non-Alcoholic Steatohepatitis
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This study's aim is to develop an algorithm for the ¹³C-Octanoate Breath Test with or without the ¹³C-Methacetin Breath Test (OBT and MBT respectively) for correlation with histological findings associated with of Non-Alcoholic Steatohepatitis (NASH) and other liver diseases using the BreathID® System
Detailed Description
Non-Alcoholic Steatohepatitis (NASH) is a growing epidemic in the western world due to the contemporary eating habits and life styles.NASH can lead to cirrhosis, hepatic carcinoma and other liver complications. There are currently some treatments available. The only definitive way of detecting NASH in patients with advanced liver disease is by liver biopsy. However, liver biopsy has disadvantages, such as sampling errors, chance of complications and does not lend itself to following up after treatment. A non-invasive test that could potentially replace biopsy and aid in NASH detection and treatment monitoring, would improve management of suspected NASH patients without the need for biopsy. This protocol will obtain the results of one or two different breath tests to provide an accurate evaluation of the liver status in patients at high risk for NASH.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult men or women (≥18 years of age)
- •Liver biopsy, indicating NAFLD/NASH, performed within 6 months prior to both breath tests OR undergoing liver biopsy to rule-out or confrim NAFLD/NASH. NOTE:The samples obtained meet defined quality criteria. (In Appendix II of protocol)
- •Any elevation of liver enzymes above the upper limit of normal (any or all of the following: AST, ALT, GGT, Alkaline phosphatase) for at least 3 months
- •No other known co-existent liver disease, excluded by appropriate serologic / other testing
- •Imaging - US / CT / MRI (if available) with the typical image of Fatty Liver or suggestive of NASH.
- •Patient (or legal guardian) able and willing to sign an Informed Consent Form
- •Can tolerate an overnight (8-hour) fast
Exclusion Criteria
- •Positive studies for any of the following within three years prior to biopsy:
- •Anti HCV positive
- •Anti HB core antibody positive
- •Iron saturation \> 60% + gene test for hereditary hemochromatosis or iron overload as defined by presence of 3+ or 4+ stainable iron on liver biopsy
- •Antinuclear antibody at a titer \> 1: 160 along with hypergammaglobulinemia and 5 times ALT normal levels
- •Alpha-1-antitrypsin level below lower limit of normal (\< 150 mg/dl) or no PAS diastase resistant globules on biopsy.
- •Primary biliary cirrhosis as defined by elevation of alkaline phosphatase greater than upper limit of normal and anti-mitochondrial antibody (AMA) of greater than 1:80 and consistent liver histology
- •Low level of ceruloplasmin
- •Drug-induced liver disease as defined on the basis of typical exposure and history
- •Patients known to have chronic liver disease other than NAFLD as routinely diagnosed by the investigator
Outcomes
Primary Outcomes
Number of Participants With Biopsy Proven Non-Alcoholic Steatohepatitis
Time Frame: 30 days
Non-Alcoholic Steatohepatitis (NASH) as determined by liver biopsy histology will be the comparator
Liver Decompensation as Measured by Area Under Receiver Operating Curve
Time Frame: 36 months
Observe if breath tests correlate to clinical outcome of liver decompensation, including ascites, variceal bleeding, hepatic encephalopathy and spontaneous bacterial peritonitis.