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

NCT02314026 | Completed Phase 2 Results

• 1 other identifier: NASH-EX-1114
• Study Type: interventional
• Target: 140
• Locations: 4 countries
• Sites: 11

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

Conditions

Non-Alcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Biopsy Proven Non-Alcoholic Steatohepatitis

  Non-Alcoholic Steatohepatitis (NASH) as determined by liver biopsy histology will be the comparator

  30 days

• Liver Decompensation as Measured by Area Under Receiver Operating Curve

  Observe if breath tests correlate to clinical outcome of liver decompensation, including ascites, variceal bleeding, hepatic encephalopathy and spontaneous bacterial peritonitis.

  36 months

Other Outcomes (1)

• Number of Participants With Adverse Events

  48 hours from last breath test

Study Arms (1)

Suspected NASH

EXPERIMENTAL

13C-Octanoate, 13C-Methacetin

Device: Suspected NASH BreathID test with 13C-Octanoate; Device: Suspected NASH Breath test with 13C Methacetin

Interventions

Suspected NASH BreathID test with 13C-Octanoate DEVICE

Subject will have breath measured before and after ingestion of solution of 100 mg 13C Octanoate dissolved in 150 cc of water

Also known as: Sodium Octanoate breath test

Suspected NASH

Suspected NASH Breath test with 13C Methacetin DEVICE

Subject will have breath measured before and after ingestion of solution of 75 mg 13C Methacetin dissolved in 150 cc of water

Suspected NASH

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Concurrent acute hepatic condition other than NAFLD
• Alcohol consumption \> 20 gm/day (0.71 oz/day) for women and \> 30 gm/day (1.06 oz/day) for men
• 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
• 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
• Patients that have had more than 10% weight change between biopsy and enrollment.

Sponsors & Collaborators

• Meridian Bioscience, Inc.: lead

Study Sites (11)

Northwestern University, Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

San Antonio Military Medical Center

Forts Sam Houston, Texas, 78234, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Liver Associates

Houston, Texas, 77030, United States

Location

Texas Liver Institute

San Antonio, Texas, 78215, United States

Location

Mary Immaculate Hospital

Newport News, Virginia, 23602, United States

Location

St. Mary's Hospital

Richmond, Virginia, 23226, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Antwerp University Hospital (UZA)

Edegem, B-2650, Belgium

Location

Hôpital Pitié Salpêtrière

Paris, 75013, France

Location

Freeman Hospital

Newcastle, NE7 7DN, United Kingdom

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Clinical trial manager
• Organization: Exalenz Bioscience

avrahamh@exalenz.com

97289737513

Study Officials

• Yaron Ilan, M.D.

  Hadassah Medical Organization

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2014
• First Posted: December 10, 2014
• Study Start: March 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: December 20, 2022
• Results First Posted: March 19, 2019

Record last verified: 2019-02

Locations

GB (1); US (8); BE (1); FR (1)