EUCTR2014-005411-16-GB
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 enrollmentApril 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
- 7 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 both breath\-tests
- •NOTE: The samples obtained must meet pre\-defined quality criteria as an inclusion criterion. (See Appendix II for biopsy quality requirements)
- •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
- •F.1\.2\.1 Number of subjects for this age range 150
Exclusion Criteria
- •1\.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
- •2\.Patients known to have chronic liver disease other than NAFLD as routinely diagnosed by the investigator
Outcomes
Primary Outcomes
Not specified
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