Chronic Liver DiseasePhase 3MBTNCT00736840
BreathID 13C-Methacetin Breath Test for Detecting Cirrhosis
A Phase 3 study testing c13 methacetin solution with breath analyzer in people with Chronic Liver Disease, run by Meridian Bioscience, Inc. at 11 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Liver Disease
- What is being tested?
- c13 methacetin solution with breath analyzer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 414 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Aug 2008to Sep 2009
- Phase
- Phase 3
- 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
- Age >18 with chronic liver disease
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United States8 sites
Medical University of South Carolina
Charleston, South Carolina, 29435
Cleveland Clinic
Cleveland, Ohio, 44195
Henry Ford Health Sytem
Detroit, Michigan, 48202
Inova Helath System
Falls Church, Virginia, 22042
St Luke's Episcopal Hospital, Baylor College of Medicine
Houston, Texas, 77030
Cedars Sinai Medical Center
Los Angeles, California, 90048
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298-0341
Israel3 sites
Soroka Medical Center
Beersheba
Carmel Medical Center
Haifa
Hadassah Medical Center
Jerusalem, 93000
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Liver Disease
- Being tested
- c13 methacetin solution with breath analyzer
- Keywords
- Methacetin, Breath, Test, Cirrhosis
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
c13 methacetin solution with breath analyzerDevice
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
| Study group | Role | What they receive |
|---|---|---|
| CLD (chronic liver disease) | Other | Chronic liver disease subjects with recent biopsy will be tested with a breath tests using a 13C enriched substrate metabolized by their liver Receives: Device: c13 methacetin solution with breath analyzer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With Likelihood of Cirrhosis Based on "Hepatic Impairment Score" (HIS)
"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.
Measured: Study day 1 after a 1 hour test
Secondary outcomes (1)
AUC of ROC (Area Under Receiver Operating Characteristic Curve)
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.
Measured: At study day 1 after 1 hour test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionSep 2009
- Study completionSep 2009
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 Chronic Liver DiseaseStudies 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 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 414 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meridian Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stuart Gordon, MD, Principal investigator, Henry Ford Health SystemAdrian Rueben, MD, Principal investigator, Medical University of South CarolinaGadi Lalazar, MD, Principal investigator, Hadassah Medical OrganizationArun Sanyal, MD, Principal investigator, Virginia Commonwealth UniversityFred Poordad, MD, Principal investigator, Cedars Sinai Health SystemK Rajender Reddy, MD, Principal investigator, University of Pennsylvania Health SystemZobair Younossi, MD, Principal investigator, Inova Health Care ServicesArthur McCullough, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00736840
- Sponsor's protocol ID
- HIS-EX-408
- Acronym
- MBT
- Status last verified
- Dec 2022
- First submitted
- 14 Aug 2008
- Last updated
- 12 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pivotal Study to Evaluate the Efficacy and Safety of the BreathID® System for Detection of Cirrhosis Using the ¹³C-methacetin Breath Test(MBT)
- ClinicalTrials.gov ID
- NCT00736840
- Acronym / sponsor ID
- MBT / HIS-EX-408
- Conditions
- Chronic Liver Disease
- Keywords
- Methacetin, Breath, Test, Cirrhosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 414 participants (actual)
- Lead sponsor
- Meridian Bioscience, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 18 Aug 2008 (estimated)
- Results
- Posted 16 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CLD (chronic liver disease) | Other | Device: c13 methacetin solution with breath analyzerChronic liver disease subjects with recent biopsy will be tested with a breath tests using a 13C enriched substrate metabolized by their liver |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age >18 with chronic liver disease
Key exclusion criteria (15 listed)
- 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
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 |
|---|---|---|
| c13 methacetin solution with breath analyzerCarbon 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 | Device | CLD (chronic liver disease) |
Primary outcome
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.
1 secondary outcome
AUC of ROC (Area Under Receiver Operating Characteristic Curve)
Time frame: At study day 1 after 1 hour test
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
- 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.
Stuart Gordon, MD principal investigator
Henry Ford Health System
Adrian Rueben, MD principal investigator
Medical University of South Carolina
Gadi Lalazar, MD principal investigator
Hadassah Medical Organization
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing c13 methacetin solution with breath analyzer in people with Chronic Liver Disease, run by Meridian Bioscience, Inc. at 11 sites in 2 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 1 inclusion and 15 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 12 Jan 2023. 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, Israel. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 16 Mar 2012). 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 Subjects With Likelihood of Cirrhosis Based on "Hepatic Impairment Score" (HIS) (time frame: Study day 1 after a 1 hour test). 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 12 Jan 2023.