BreathID 13C-Methacetin Breath Test for Detecting Cirrhosis (MBT)

December 19, 2022 updated by: Meridian Bioscience, Inc.

Pivotal Study to Evaluate the Efficacy and Safety of the BreathID® System for Detection of Cirrhosis Using the ¹³C-methacetin Breath Test(MBT)

This trial is a pivotal trial to validate the use of a 13 C labeled substrate called methacetin and the BreathID automatic breath testing system, for determination of cirrhosis in patients with chronic liver disease.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients with chronic liver disease who have a recent biopsy will be offered a breath test. Correlation will be shown between histology and breath test in determining cirrhosis.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
414

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Beer Sheba, Israel
        • Soroka Medical Center
      • Haifa, Israel
        • Carmel Medical Center
      • Jerusalem, Israel, 93000
        • Hadassah Medical Center
  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health Sytem
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Health System
    • South Carolina
      • Charleston, South Carolina, United States, 29435
        • Medical University of South Carolina
    • Texas
      • Houston, Texas, United States, 77030
        • St Luke's Episcopal Hospital, Baylor College of Medicine
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Helath System
      • Richmond, Virginia, United States, 23298-0341
        • Virginia Commonwealth University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age >18 with chronic liver disease

Exclusion Criteria:

  • Patients that are taking hepatotoxin drug.
  • Patient with severe congestive heart failure
  • Patient with severe pulmonary hypertension
  • Patient with uncontrolled diabetes mellitus
  • Patient with previous surgical bypass surgery for morbid obesity
  • Patient with extensive small bowel resection
  • Patient currently receiving total parenteral nutrition
  • Patient is a recipients of any organ transplant
  • Patients that received any anti-viral treatment within the past year
  • Women who are pregnant
  • Patient allergic to acetaminophen (such as Tylenol or any other related medications)
  • Patient with history of chronic obstructive pulmonary disease or symptomatic bronchial asthma
  • Patients unable to sign informed consent
  • Patients that based on the opinion of the investigator should not be enrolled into this study
  • Patients that are participating in other clinical trials evaluating experimental treatments or procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: CLD (chronic liver disease)
Chronic liver disease subjects with recent biopsy will be tested with a breath tests using a 13C enriched substrate metabolized by their liver
Device: c13 methacetin solution with breath analyzer
Carbon 13 methacetin 75mg dissolved in 150 ml is given to the subject and metabolism is measured by a breath analyzer after decomposed by the liver

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Subjects With Likelihood of Cirrhosis Based on "Hepatic Impairment Score" (HIS)
Time Frame: Study day 1 after a 1 hour test
"Hepatic Impairment Score" (HIS) is a score based on breath test parameters and demographic parameters of the subject being tested. A HIS value greater than 0.14 would mean that the subject is likely to be cirrhotic (based on biopsy result as the gold standard). The HIS is a probability score,i.e. ranges from 0 to 1, where 0 would mean the lowest probability of having liver cirrhosis and 1 would be the highest probability of having liver cirrhosis. This would be compared to the actual biopsy result of cirrhosis detection as the gold standard.
Study day 1 after a 1 hour test

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
AUC of ROC (Area Under Receiver Operating Characteristic Curve)
Time Frame: At study day 1 after 1 hour test
The AUC represents a summary measure of the ROC curve and is the accuracy of the HIS in detecting cirrhosis compared to the gold standard of biopsy.
At study day 1 after 1 hour test

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Meridian Bioscience, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Arun Sanyal, MD, Virginia Commonwealth University
  • Principal Investigator: Stuart Gordon, MD, Henry Ford Health System
  • Principal Investigator: Adrian Rueben, MD, Medical University of South Carolina
  • Principal Investigator: Fred Poordad, MD, Cedars Sinai Health System
  • Principal Investigator: K Rajender Reddy, MD, University of Pennsylvania Health System
  • Principal Investigator: Zobair Younossi, MD, Inova Health Care Services
  • Principal Investigator: Arthur McCullough, MD, The Cleveland Clinic
  • Principal Investigator: John Vierling, MD, St. Luke's Episcopal Hospital, Baylor College of Medicine
  • Principal Investigator: Alexander Fich, MD, Soroka University Medical Center
  • Principal Investigator: Eli Zuckerman, MD, Carmel Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 18, 2008

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HIS-EX-408

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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