CirrhosisPhase 3NCT01157845
Use of Methacetin Breath Test to Predict Liver Failure in Patients With Cirrhosis
A Phase 3 study testing BreathID (Methacetin breath test) in people with Cirrhosis, run by Virginia Commonwealth University at 4 sites in 2 countries.
Trial summary
The methacetin breath test (MBT) is a non-invasive liver function test which measures the ability of the liver to metabolize a tracer dose of a compound to carbon dioxide, which is exhaled. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis
- What is being tested?
- BreathID (Methacetin breath test)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Mar 2010to Jul 2012
- 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
- Being considered for placement or already on the liver transplantation waiting list
- Cirrhosis caused by any cause of chronic liver disease.
- Age > 18 years
Who cannot join
- Known or suspected hepatocellular carcinoma
- Prior TIPS placement
- Severe congestive heart failure
- Severe pulmonary hypertension
- Uncontrolled diabetes mellitus (HBA1C >9.5%)
- Any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication.
Show all 16Show fewer
- Previous surgical bypass surgery for morbid obesity (BMI >45)
- Extensive small bowel resection
- Patients currently receiving total parenteral nutrition if they have contraindications to oral drugs
- Women who are pregnant
- Patients who are allergic to acetaminophen/ paracetamol or any other related medications
- Patients with an acute current exacerbation of chronic obstructive pulmonary disease or bronchial asthma.
- Patients that are taking hepatotoxin drugs
- Patient, based on the opinion of the investigator, should not be enrolled into this study
- Patient is unable or unwilling to sign informed consent.
- Patients that are participating in other clinical trials evaluating experimental treatments or procedures
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
Henry Ford Health System
Detroit, Michigan, 48202
Virginia Commonwealth University Medical Center
Richmond, Virginia, 23298
About this study
Official title: Use of the BreathID Methacetin Breath Test to Assess Hepatic Metabolic Reserve and to Predict Hepatic Decompensation in Patients Awaiting Liver Transplantation
The methacetin breath test (MBT) is a non-invasive liver function test which measures the ability of the liver to metabolize a tracer dose of a compound to carbon dioxide, which is exhaled. The study hypothesis is that measurement of the MBT will allow earlier detection of a decline in liver function in patients with cirrhosis who are awaiting liver transplantation.
- Conditions
- Cirrhosis
- Being tested
- BreathID (Methacetin breath test)
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BreathID (Methacetin breath test)Device
Also called BreathID (Exalenz Bioscience LTD)
13C-labeled methacetin (75 mg) is given to the patient by mouth in a small volume of water, and expired 13C-labeled carbon dioxide is measured from a nasal cannula.
| Study group | Role | What they receive |
|---|---|---|
| Laboratory assay | Experimental | Not described Receives: Device: BreathID (Methacetin breath test) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality From Liver Failure
Patient dies of liver-related causes within 1 year of study entry
Measured: 1 year
Secondary outcomes (1)
Liver Transplantation
Patient experiences complications of liver failure within 1 year of study entry and undergoes liver transplantation
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2010 (estimated)
- Study startMar 2010
- Primary completionJul 2012
- Study completionJul 2012
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- Meridian Bioscience, Inc.
- Responsible party
- Sponsor
- Investigators
- Richard T Stravitz, MD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01157845
- Sponsor's protocol ID
- VirginiaCU HM12041
- Status last verified
- Apr 2014
- First submitted
- 2 Jul 2010
- Last updated
- 16 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Braden B, Faust D, Sarrazin U, Zeuzem S, Dietrich CF, Caspary WF, Sarrazin C. 13C-methacetin breath test as liver function test in patients with chronic hepatitis C virus infection. Aliment Pharmacol Ther. 2005 Jan 15;21(2):179-85. doi: 10.1111/j.1365-2036.2005.02317.x.
PubMed 15679768
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the BreathID Methacetin Breath Test to Assess Hepatic Metabolic Reserve and to Predict Hepatic Decompensation in Patients Awaiting Liver Transplantation
- ClinicalTrials.gov ID
- NCT01157845
- Acronym / sponsor ID
- VirginiaCU HM12041
- Conditions
- Cirrhosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- Meridian Bioscience, Inc.
- Study start
- Mar 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 7 Jul 2010 (estimated)
- Results
- Posted 4 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The methacetin breath test (MBT) is a non-invasive liver function test which measures the ability of the liver to metabolize a tracer dose of a compound to carbon dioxide, which is exhaled. The study hypothesis is that measurement of the MBT will allow earlier detection of a decline in liver function in patients with cirrhosis who are awaiting liver transplantation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laboratory assay | Experimental | Device: BreathID (Methacetin breath test) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being considered for placement or already on the liver transplantation waiting list
- Cirrhosis caused by any cause of chronic liver disease.
- Age > 18 years
Key exclusion criteria (16 listed)
- Known or suspected hepatocellular carcinoma
- Prior TIPS placement
- Severe congestive heart failure
- Severe pulmonary hypertension
- Uncontrolled diabetes mellitus (HBA1C >9.5%)
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 |
|---|---|---|
| BreathID (Methacetin breath test)Also: BreathID (Exalenz Bioscience LTD)13C-labeled methacetin (75 mg) is given to the patient by mouth in a small volume of water, and expired 13C-labeled carbon dioxide is measured from a nasal cannula. | Device | Laboratory assay |
Primary outcome
Mortality From Liver Failure
Time frame: 1 year
Patient dies of liver-related causes within 1 year of study entry
1 secondary outcome
Liver Transplantation
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15679768Braden B, Faust D, Sarrazin U, Zeuzem S, Dietrich CF, Caspary WF, Sarrazin C. 13C-methacetin breath test as liver function test in patients with chronic hepatitis C virus infection. Aliment Pharmacol Ther. 2005 Jan 15;21(2):179-85. doi: 10.1111/j.1365-2036.2005.02317.x.
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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.
Richard T Stravitz, MD principal investigator
Virginia Commonwealth University
4 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 BreathID (Methacetin breath test) in people with Cirrhosis, run by Virginia Commonwealth University at 4 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 3 inclusion and 16 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 16 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 4 Mar 2014). 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?
Mortality From Liver Failure (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01157845, which also lists 1 linked publication.
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 16 May 2014.