Study aiming at finding a formula which will allow the BreathID system to provide information similar to the ones provided by the analysis of a liver biopsy, on the disease called Non-Alcoholic Fatty Liver Disease.

Phase 1

• Conditions: Patients with Non-Alcoholic Fatty Liver Disease; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2014-005411-16-ES
• Lead Sponsor: Exalenz Bioscience Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-25
• Last Update Posted: 24 October 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

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.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

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
3.Concurrent acute hepatic condition other than NAFLD
4.Alcohol consumption > 20 gm/day (0.71 oz/day) for women and > 30 gm/day (1.06 oz/day) for men
5.Drugs that may interfere with octanoate metabolism or that can also cause NAFLD independent of the metabolic syndrome, including: corticosteroids, amiodarone, tetracycline, valproic acid, methotrexate, stavudine, zidovudine
6.When MBT is performed, subject should not have taken any of the following at least 48 hours prior to the breath test: Acyclovir , allopurinol, carbamazepine, cimetidine, ciprofloxacin, daidzein, (herbal) disulfiram, echinacea, enoxacin, famotidine, fluvoxamine, methoxsalen, mexiletine, montelukast, norfloxacin, phenylpropanolamine, phenytoin, propafenone, rifampin, terbinafine, ticlopidine, thiabendazole, verapamil, zileuton or oral contraceptives or any medication that might interfere with Methacetin metabolism or might affect CYP 1A2
7.Patients that have had more than 10% weight change between biopsy and enrollment.
8.Hypersensitivity to any of the study substrates: Octanoate or Methacetin and their metabolites, i.e. paracetamol, acetaminophen
9.Known extra-hepatic diseases including but not limited to: severe congestive heart failure (NIHA>2), known severe pulmonary hypertension (>35 mmHg), history of chronic obstructive pulmonary disease or uncontrolled symptomatic bronchial asthma or uncontrolled diabetes mellitus (HA1c>9.5%)
10.Previous surgical GI bypass surgery
11.Extensive small bowel resection (>100 cm)
12.Known uncontrolled malabsorption or diarrhea
13.Concurrent total parenteral nutrition
14.Any organ transplant
15.Patients receiving any anti-viral treatment or any other liver directed therapy, procedure or surgery between the time of the biopsy and the breath test
16.Pregnant or breast feeding
17.Patients unable or refusing to sign informed consent
18.Patients that, based on the opinion of the investigator, should not be enrolled into this study due to safety / adherence reasons.
19.Patients participating in other clinical trials and already receiving experimental treatments or procedures
20.Patients with suspected or documented hepatocellular carcinoma by ultra-sound or other imaging modality.
21.Patients diagnosed with partial / complete portal venous occlusion, hepatic venous occlusion, previous PHT surgery, or placement of a trans-jugular intrahepatic porto-systemic shunt (TIPS) according to initial imaging studies.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified