Hepatitis CPhase 2NCT00350714
BreathID Multi-center HCV Liver Breath Test Study
A Phase 2 study testing MBT and BreathID in people with Hepatitis C, run by Meridian Bioscience, Inc. at 5 sites in 2 countries.
Trial summary
The goal of this study is to validate the BreathID 13C-methacetin breath test (MBT) as a non-invasive simple-to-use metabolic test, which could be utilized to detect severe liver fibrosis (>2 in METAVIR) in patients with chronic HCV liver disease.The test is a breath-test using a free-standing device (BreathID®) that… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- MBT and BreathID
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Jul 2006to Feb 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Patients with a confirmed diagnosis of Chronic HCV only : ii. Patients for whom a liver biopsy has been performed within the last 90 days or who will undergo a liver biopsy within the time frame of the study.
Who cannot join
- Severe congestive heart failure. ii. Severe pulmonary hypertension. iii.Chronic renal insufficiency defined by a serum creatinine above the limits of normal. iv. Uncontrolled diabetes mellitus (need definition).v.Any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication. vi.Proven or suspected hepatocellular carcinoma. vii. Previous surgical bypass surgery for morbid obesity viii.Extensive small bowel resection. ix.Patients currently receiving total parenteral nutrition x.Recipients of any organ transplant. xi.Other co-existent liver disease.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Baylor College of Medicine
Houston, Texas, 77030
Mount Sinai School of Medicine
New York, New York, 10029-6574
U.S. Dept. of Veteran Affairs, Hunter Holmes McGuire Medical Center
Richmond, Virginia, 23249-0001
Virginia Commonwealth Univeristy
Richmond, Virginia, 23284
About this study
Official title: Validation of a Breath Test for Assessment of Liver Fibrosis in Patients With Chronic Hepatitis C Viral Infection
The goal of this study is to validate the BreathID 13C-methacetin breath test (MBT) as a non-invasive simple-to-use metabolic test, which could be utilized to detect severe liver fibrosis (>2 in METAVIR) in patients with chronic HCV liver disease.The test is a breath-test using a free-standing device (BreathID®) that measures metabolization of a 13C-labeled substrate (13C-methacetin) in real time.
Read the detailed description
Percutaneous liver biopsy has been utilized for decades to assess the severity of chronic HCV liver disease. During this procedure a core sample of liver is obtained and examined histologically for the presence of inflammation, fibrosis and other features characteristic of specific liver disorders. Several grading systems have been developed over the past 2 decades to quantify the overall severity of the liver biopsy specimen. Although liver biopsy is the gold standard by which to assess liver disease severity, the procedure has significant limitations. Liver biopsy is a costly, invasive procedure with risks for morbidity and mortality and may cause some discomfort to the patient. Percutaneous liver biopsy is associated with potential complications, including bleeding (1%-3%), pain (20%-30%), bile peritonitis (<1%), pneumothorax (<1%), punctured viscera (<1%), and death. In addition, liver biopsy and examination of liver histology is subject to sampling variation and the manner by which these findings are evaluated and reported by individual pathologists.
Breath testing with 13C-labeled substrates provide a safe, non-invasive means for evaluating hepatic metabolism that is correlated with liver histology. 13C is a stable, non-radioactive isotope, which can by incorporated into a specific location within a test substrate so that it would be released when the compound is metabolized by the liver. Ideally, the 13C-compound would need to be administered orally, rapidly absorbed, exclusively metabolized by the liver metabolism and 13C would be measured in exhaled breath within 20-30 minutes. Hepatic metabolism of the compound is assessed by measuring the ratio of 13C/12C in exhaled breath. The ability to detect, differentiate and quantify 13C and 12C in exhaled CO2 has been greatly facilitated by the recent development of the BreathID® collection system and analyzer unit.
The compound selected for this study will be 13C-methacetin. Methacetin meets all of the qualifications for an excellent substrate for liver breath tests. It is a non-toxic small molecule. 13C can be synthesized into a key location within this agent. It can be administered orally in solution. It is rapidly absorbed and metabolized by hepatic microsomes and this process releases CO2 as a by-product in exhaled breath. No reports of any complications or side effects using this substance have been reported.
13C-methacetin is rapidly absorbed and metabolized by healthy liver cells into acetaminophen and 13CO2. The resultant CO2 can be measured in the exhaled breath. The amount of metabolized methacetin indicates the capability of the liver to accomplish one of its main physiological tasks and has been shown to correlate with liver fibrosis and cirrhosis.
- Conditions
- Hepatitis C
- Being tested
- MBT and BreathID
- Keywords
- HCV (Hepatitis C Virus), MBT (Methacetin Breath Test), Hepatitis C Virus Patients
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBT and BreathIDOther
75 mg methacetin (c13 labelled) dissolved in 150 cc water ingested and breath collected before and after ingestion.
| Study group | Role | What they receive |
|---|---|---|
| MBT | Experimental | C13 methacetin dissolved in water to be ingested after breath baseline collected. Metabolism to measured in real time. Receives: Other: MBT and BreathID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of Breath Test (MBT) to Fibrosis
13 C Lebeled substrate is metabolized by Liver and reflects liver function. It is hypothesized that this correlated to liver fibrosis
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2006 (estimated)
- Study startJul 2006
- Primary completionFeb 2007
- Study completionFeb 2007
Why it stopped: Due to FDA comments, protocol changed; new trial will be proposed shortly
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meridian Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Icahn School of Medicine at Mount Sinai, Baylor College of Medicine, Virginia Commonwealth University, Hadassah Medical Organization, US Department of Veterans Affairs
- Investigators
- Doug Dieterich, MD, Principal investigator, Icahn School of Medicine at Mount SinaiJohn M Vierling, MD, Principal investigator, Baylor College of MedicineMitchell Shiffman, MD, Principal investigator, Virginia Commonwealth UniversityMaya Margalit, MD, Principal investigator, Hadassah Medical OrganizationDouglas M. Heuman, M.D., Principal investigator, U.S. Dept. of Veteran Affairs, Hunter Holmes McGuire Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00350714
- Sponsor's protocol ID
- MBVH-0706
- Status last verified
- Dec 2022
- First submitted
- 10 Jul 2006
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
O. Goetze; N. Selzner; A. Grau; M. Fried; T. Gerlach; B. Muellhaupt 13C-Methacetin Breath Test by Online Molecular Correlation Spectroscopy Compared to APRI and Liver Biopsy for the Assessment of Fibrosis in Chronic Hepatitis C , S1047. Abstarct presented at DDW 2006
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
- Validation of a Breath Test for Assessment of Liver Fibrosis in Patients With Chronic Hepatitis C Viral Infection
- ClinicalTrials.gov ID
- NCT00350714
- Acronym / sponsor ID
- MBVH-0706
- Conditions
- Hepatitis C
- Keywords
- HCV (Hepatitis C Virus), MBT (Methacetin Breath Test), Hepatitis C Virus Patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to FDA comments, protocol changed; new trial will be proposed shortly
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Meridian Bioscience, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Icahn School of Medicine at Mount Sinai, Baylor College of Medicine, Virginia Commonwealth University, Hadassah Medical Organization, US Department of Veterans Affairs
- Study start
- Jul 2006
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 11 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to validate the BreathID 13C-methacetin breath test (MBT) as a non-invasive simple-to-use metabolic test, which could be utilized to detect severe liver fibrosis (>2 in METAVIR) in patients with chronic HCV liver disease.The test is a breath-test using a free-standing device (BreathID®) that measures metabolization of a 13C-labeled substrate (13C-methacetin) in real time.
Detailed description
Percutaneous liver biopsy has been utilized for decades to assess the severity of chronic HCV liver disease. During this procedure a core sample of liver is obtained and examined histologically for the presence of inflammation, fibrosis and other features characteristic of specific liver disorders. Several grading systems have been developed over the past 2 decades to quantify the overall severity of the liver biopsy specimen. Although liver biopsy is the gold standard by which to assess liver disease severity, the procedure has significant limitations. Liver biopsy is a costly, invasive procedure with risks for morbidity and mortality and may cause some discomfort to the patient. Percutaneous liver biopsy is associated with potential complications, including bleeding (1%-3%), pain (20%-30%), bile peritonitis (<1%), pneumothorax (<1%), punctured viscera (<1%), and death. In addition, liver biopsy and examination of liver histology is subject to sampling variation and the manner by which these findings are evaluated and reported by individual pathologists.
Breath testing with 13C-labeled substrates provide a safe, non-invasive means for evaluating hepatic metabolism that is correlated with liver histology. 13C is a stable, non-radioactive isotope, which can by incorporated into a specific location within a test substrate so that it would be released when the compound is metabolized by the liver. Ideally, the 13C-compound would need to be administered orally, rapidly absorbed, exclusively metabolized by the liver metabolism and 13C would be measured in exhaled breath within 20-30 minutes. Hepatic metabolism of the compound is assessed by measuring the ratio of 13C/12C in exhaled breath. The ability to detect, differentiate and quantify 13C and 12C in exhaled CO2 has been greatly facilitated by the recent development of the BreathID® collection system and analyzer unit.
The compound selected for this study will be 13C-methacetin. Methacetin meets all of the qualifications for an excellent substrate for liver breath tests. It is a non-toxic small molecule. 13C can be synthesized into a key location within this agent. It can be administered orally in solution. It is rapidly absorbed and metabolized by hepatic microsomes and this process releases CO2 as a by-product in exhaled breath. No reports of any complications or side effects using this substance have been reported.
13C-methacetin is rapidly absorbed and metabolized by healthy liver cells into acetaminophen and 13CO2. The resultant CO2 can be measured in the exhaled breath. The amount of metabolized methacetin indicates the capability of the liver to accomplish one of its main physiological tasks and has been shown to correlate with liver fibrosis and cirrhosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MBT | Experimental | Other: MBT and BreathIDC13 methacetin dissolved in water to be ingested after breath baseline collected. Metabolism to measured in real time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with a confirmed diagnosis of Chronic HCV only : ii. Patients for whom a liver biopsy has been performed within the last 90 days or who will undergo a liver biopsy within the time frame of the study.
Key exclusion criteria (1 listed)
- Severe congestive heart failure. ii. Severe pulmonary hypertension. iii.Chronic renal insufficiency defined by a serum creatinine above the limits of normal. iv. Uncontrolled diabetes mellitus (need definition).v.Any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication. vi.Proven or suspected hepatocellular carcinoma. vii. Previous surgical bypass surgery for morbid obesity viii.Extensive small bowel resection. ix.Patients currently receiving total parenteral nutrition x.Recipients of any organ transplant. xi.Other co-existent liver disease.
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 |
|---|---|---|
| MBT and BreathID75 mg methacetin (c13 labelled) dissolved in 150 cc water ingested and breath collected before and after ingestion. | Other | MBT |
Primary outcome
Correlation of Breath Test (MBT) to Fibrosis
Time frame: 12 months
13 C Lebeled substrate is metabolized by Liver and reflects liver function. It is hypothesized that this correlated to liver fibrosis
Results and safety
The study was stopped early (reason given: Due to FDA comments, protocol changed; new trial will be proposed shortly). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Results publicationO. Goetze; N. Selzner; A. Grau; M. Fried; T. Gerlach; B. Muellhaupt 13C-Methacetin Breath Test by Online Molecular Correlation Spectroscopy Compared to APRI and Liver Biopsy for the Assessment of Fibrosis in Chronic Hepatitis C , S1047. Abstarct presented at DDW 2006
- Website of BreathID whose device will be used in this studyLink provided by the sponsor.
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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.
Doug Dieterich, MD principal investigator
Icahn School of Medicine at Mount Sinai
John M Vierling, MD principal investigator
Baylor College of Medicine
Mitchell Shiffman, MD principal investigator
Virginia Commonwealth University
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MBT and BreathID in people with Hepatitis C, run by Meridian Bioscience, Inc. at 5 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 1 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: stopped early, 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 5 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 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?
The study was stopped early (reason given: Due to FDA comments, protocol changed; new trial will be proposed shortly). Results are not available in the source record.
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?
Correlation of Breath Test (MBT) to Fibrosis (time frame: 12 months). 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 NCT00350714, 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 20 Dec 2022.