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BREATHID Octanoate Breath Test With or Without Methacetin Breath Test for Correlation With Biopsy in NASH

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Exalenz Bioscience LTD.
ClinicalTrials.gov Identifier:
NCT02314026
First received: December 4, 2014
Last updated: June 11, 2017
Last verified: January 2017
  Purpose
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

Condition Intervention Phase
Non-Alcoholic Steatohepatitis Device: Suspected NASH BreathID test with 13C-Octanoate Device: Suspected NASH Breath test with 13C Methacetin Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Exalenz Bioscience LTD.:

Primary Outcome Measures:
  • NASH (biopsy proven) [ Time Frame: 30 days ]
    Liver biopsy determining NASH will be the comparator


Secondary Outcome Measures:
  • Liver decompensation [ Time Frame: 36 months ]
    Observe if breath tests correlate to clinical outcome of liver decompensation


Other Outcome Measures:
  • Safety outcome-Adverse events [ Time Frame: 48 hours from last breath test ]
    A phone call will be made to the subject 48 hours after the last breath test to confirm that no adverse events related to breath test have been experienced.


Enrollment: 140
Actual Study Start Date: March 2015
Study Completion Date: June 2017
Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Suspected NASH
13C-Octanoate, 13C-Methacetin
Device: Suspected NASH BreathID test with 13C-Octanoate
Subject will have breath measured before and after ingestion of solution of 100 mg 13C Octanoate dissolved in 150 cc of water
Other Name: Sodium Octanoate breath test
Device: Suspected NASH Breath test with 13C Methacetin
Subject will have breath measured before and after ingestion of solution of 75 mg 13C Methacetin dissolved in 150 cc of water

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult men or women (≥18 years of age)
  2. 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)
  3. 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
  4. No other known co-existent liver disease, excluded by appropriate serologic / other testing
  5. Imaging - US / CT / MRI (if available) with the typical image of Fatty Liver or suggestive of NASH.
  6. Patient (or legal guardian) able and willing to sign an Informed Consent Form
  7. Can tolerate an overnight (8-hour) fast

Exclusion Criteria:

  1. Positive studies for any of the following within three years prior to biopsy:

    1. Anti HCV positive
    2. Anti HB core antibody positive
    3. Iron saturation > 60% + gene test for hereditary hemochromatosis or iron overload as defined by presence of 3+ or 4+ stainable iron on liver biopsy
    4. Antinuclear antibody at a titer > 1: 160 along with hypergammaglobulinemia and 5 times ALT normal levels
    5. Alpha-1-antitrypsin level below lower limit of normal (< 150 mg/dl) or no PAS diastase resistant globules on biopsy.
    6. 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
    7. Low level of ceruloplasmin
    8. 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 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 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; i.e. Octanoate or Methacetin respectively
  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 and/or legal guardian 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 transjugular intrahepatic portosystemic shunt (TIPS) according to initial imaging studies.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02314026

Locations
United States, Illinois
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, United States, 60611
United States, Texas
San Antonio Military Medical Center
Fort Sam Houston, Texas, United States, 78234
Baylor College of Medicine
Houston, Texas, United States, 77030
Liver Associates
Houston, Texas, United States, 77030
Texas Liver Institute
San Antonio, Texas, United States, 78215
United States, Virginia
Mary Immaculate Hospital
Newport News, Virginia, United States, 23602
St. Mary's Hospital
Richmond, Virginia, United States, 23226
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Belgium
Antwerp University Hospital (UZA)
Edegem, Belgium, B-2650
France
Hôpital Pitié Salpêtrière
Paris, France, 75013
United Kingdom
Freeman Hospital
New Castle, United Kingdom, NE7 7DN
Sponsors and Collaborators
Exalenz Bioscience LTD.
Investigators
Study Director: Yaron Ilan, M.D. Hadassah Medical Organization
  More Information

Responsible Party: Exalenz Bioscience LTD.
ClinicalTrials.gov Identifier: NCT02314026     History of Changes
Other Study ID Numbers: NASH-EX-1114
Study First Received: December 4, 2014
Last Updated: June 11, 2017

Additional relevant MeSH terms:
Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 19, 2017