EUCTR2014-005411-16-BE
Active, not recruiting
Phase 1
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 of Non-Alcoholic Fatty Liver Disease (NAFLD). - NASH-EX-1114
Exalenz Bioscience Ltd.0 sites200 target enrollmentSeptember 8, 2015
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients with Non-Alcoholic Fatty Liver Disease
- Sponsor
- Exalenz Bioscience Ltd.
- Enrollment
- 200
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Adult men or women (\=18 years of age)
- •2\.Liver biopsy, indicated to rule\-out or confirm NAFLD, performed within 6 months prior to or 1 month after both breath\-tests
- •NOTE: The samples obtained must meet pre\-defined quality criteria as an inclusion criterion. (See Appendix II for biopsy quality requirements)
- •OR: Undergoing Liver biopsy to rule\-out or confirm NAFLD/NASH.
- •3\.No other known co\-existent liver disease, excluded by appropriate serologic / other testing
- •4\.Patient able and willing to sign an Informed Consent Form
- •5\.Can tolerate an overnight (8\-hour) fast
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •1\.Positive studies for any of the following within three years prior to biopsy:
- •\*Anti HCV positive
- •\*Anti HBsAg 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 (\< 10 gn/mL)
- •\*Drug\-induced liver disease as defined on the basis of typical exposure and history
- •Note: These studies do not need to be performed if they are not available, as it is assumed that if they are not on file, the condition does not exist
Outcomes
Primary Outcomes
Not specified
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