Non-Alcoholic SteatohepatitisPhase 2NCT02314026
BREATHID Octanoate Breath Test With or Without Methacetin Breath Test for Correlation With Biopsy in NASH
A Phase 2 study testing Suspected NASH BreathID test with 13C-Octanoate and Suspected NASH Breath test with 13C Methacetin in people with Non-Alcoholic Steatohepatitis, run by Meridian Bioscience, Inc. at 11 sites in 4 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Alcoholic Steatohepatitis
- What is being tested?
- Suspected NASH BreathID test with 13C-Octanoate and Suspected NASH Breath test with 13C Methacetin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 11 sitesin 4 countries
- Study dates
- Mar 2015to Jun 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
- Hypersensitivity to any of the study substrates; i.e. Octanoate or Methacetin respectively
- 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%)
- Previous surgical GI bypass surgery
- Extensive small bowel resection (>100 cm)
- Known uncontrolled malabsorption or diarrhea
- Concurrent total parenteral nutrition
- Any organ transplant
- 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
- Pregnant or breast feeding
- Patients and/or legal guardian unable or refusing to sign informed consent
- Patients that, based on the opinion of the investigator, should not be enrolled into this study due to safety / adherence reasons.
- Patients participating in other clinical trials and already receiving experimental treatments or procedures
- Patients with suspected or documented hepatocellular carcinoma by ultra-sound or other imaging modality
- 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.
Trial locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
United States8 sites
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, 60611
San Antonio Military Medical Center
Forts Sam Houston, Texas, 78234
Baylor College of Medicine
Houston, Texas, 77030
Liver Associates
Houston, Texas, 77030
Mary Immaculate Hospital
Newport News, Virginia, 23602
St. Mary's Hospital
Richmond, Virginia, 23226
Virginia Commonwealth University
Richmond, Virginia, 23298
Texas Liver Institute
San Antonio, Texas, 78215
About this study
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
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
Read the 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.
- Conditions
- Non-Alcoholic Steatohepatitis
- Being tested
- Suspected NASH BreathID test with 13C-Octanoate, Suspected NASH Breath test with 13C Methacetin
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suspected NASH BreathID test with 13C-OctanoateDevice
Also called Sodium Octanoate breath test
Subject will have breath measured before and after ingestion of solution of 100 mg 13C Octanoate dissolved in 150 cc of water
Suspected NASH Breath test with 13C MethacetinDevice
Subject will have breath measured before and after ingestion of solution of 75 mg 13C Methacetin dissolved in 150 cc of water
| Study group | Role | What they receive |
|---|---|---|
| Suspected NASH | Experimental | 13C-Octanoate, 13C-Methacetin Receives: Device: Suspected NASH BreathID test with 13C-Octanoate; Device: Suspected NASH Breath test with 13C Methacetin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Biopsy Proven Non-Alcoholic Steatohepatitis
Non-Alcoholic Steatohepatitis (NASH) as determined by liver biopsy histology will be the comparator
Measured: 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.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2014 (estimated)
- Study startMar 2015
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-Alcoholic SteatohepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meridian Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yaron Ilan, M.D., Study director, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02314026
- Sponsor's protocol ID
- NASH-EX-1114
- Status last verified
- Feb 2019
- First submitted
- 4 Dec 2014
- Last updated
- 20 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02314026
- Acronym / sponsor ID
- NASH-EX-1114
- Conditions
- Non-Alcoholic Steatohepatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Meridian Bioscience, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 10 Dec 2014 (estimated)
- Results
- Posted 19 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspected NASH | Experimental | Device: Suspected NASH BreathID test with 13C-Octanoate, Device: Suspected NASH Breath test with 13C Methacetin13C-Octanoate, 13C-Methacetin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (29 listed)
- Positive studies for any of the following within three years prior to biopsy:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Suspected NASH BreathID test with 13C-OctanoateAlso: Sodium Octanoate breath testSubject will have breath measured before and after ingestion of solution of 100 mg 13C Octanoate dissolved in 150 cc of water | Device | Suspected NASH |
| Suspected NASH Breath test with 13C MethacetinSubject will have breath measured before and after ingestion of solution of 75 mg 13C Methacetin dissolved in 150 cc of water | Device | Suspected NASH |
Primary outcome
Number of Participants With Biopsy Proven Non-Alcoholic Steatohepatitis
Time frame: 30 days
Non-Alcoholic Steatohepatitis (NASH) as determined by liver biopsy histology will be the comparator
Liver Decompensation as Measured by Area Under Receiver Operating Curve
Time frame: 36 months
Observe if breath tests correlate to clinical outcome of liver decompensation, including ascites, variceal bleeding, hepatic encephalopathy and spontaneous bacterial peritonitis.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yaron Ilan, M.D. study director
Hadassah Medical Organization
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Suspected NASH BreathID test with 13C-Octanoate and Suspected NASH Breath test with 13C Methacetin in people with Non-Alcoholic Steatohepatitis, run by Meridian Bioscience, Inc. at 11 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Belgium, France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Biopsy Proven Non-Alcoholic Steatohepatitis (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.