Cirrhosis
Conditions
Brief 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. 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.
Interventions
DEVICEBreathID (Methacetin breath test)
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.
Sponsors
Meridian Bioscience, Inc.
Virginia Commonwealth University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Being considered for placement or already on the liver transplantation waiting list 2. Cirrhosis caused by any cause of chronic liver disease. 3. Age \> 18 years
Exclusion criteria
1. Known or suspected hepatocellular carcinoma 2. Prior TIPS placement 3. Severe congestive heart failure 4. Severe pulmonary hypertension 5. Uncontrolled diabetes mellitus (HBA1C \>9.5%) 6. Any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication. 7. Previous surgical bypass surgery for morbid obesity (BMI \>45) 8. Extensive small bowel resection 9. Patients currently receiving total parenteral nutrition if they have contraindications to oral drugs 10. Women who are pregnant 11. Patients who are allergic to acetaminophen/ paracetamol or any other related medications 12. Patients with an acute current exacerbation of chronic obstructive pulmonary disease or bronchial asthma. 13. Patients that are taking hepatotoxin drugs 14. Patient, based on the opinion of the investigator, should not be enrolled into this study 15. Patient is unable or unwilling to sign informed consent. 16. Patients that are participating in other clinical trials evaluating experimental treatments or procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality From Liver Failure | 1 year | Patient dies of liver-related causes within 1 year of study entry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Liver Transplantation | 1 year | Patient experiences complications of liver failure within 1 year of study entry and undergoes liver transplantation |
Countries
Israel, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Laboratory Assay BreathID (Methacetin breath test): 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. | 165 |
| Total | 165 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Device malfunction | 1 |
| Overall Study | Lost to Follow-up | 5 |
| Overall Study | Physician Decision | 3 |
| Overall Study | Protocol Violation | 13 |
| Overall Study | Study was ended | 1 |
| Overall Study | Withdrawal by Subject | 12 |
Baseline characteristics
| Characteristic | Laboratory Assay |
|---|---|
| Age, Continuous | 55.7 years STANDARD_DEVIATION 10.43 |
| Chronic Liver Disease Etiology Alcoholic Liver Disease | 22 participants |
| Chronic Liver Disease Etiology Cholestatic | 16 participants |
| Chronic Liver Disease Etiology Cryptogenic cirrhosis | 17 participants |
| Chronic Liver Disease Etiology Fatty LIver | 19 participants |
| Chronic Liver Disease Etiology Hepatitis B | 5 participants |
| Chronic Liver Disease Etiology Hepatitis C | 75 participants |
| Chronic Liver Disease Etiology Other | 11 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 163 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment Israel | 66 participants |
| Region of Enrollment United States | 99 participants |
| Sex: Female, Male Female | 59 Participants |
| Sex: Female, Male Male | 106 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 92 / 165 |
| serious Total, serious adverse events | 107 / 165 |
Outcome results
Primary
Mortality From Liver Failure
Patient dies of liver-related causes within 1 year of study entry
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Laboratory Assay | Mortality From Liver Failure | 11 participants |
Secondary
Liver Transplantation
Patient experiences complications of liver failure within 1 year of study entry and undergoes liver transplantation
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Laboratory Assay | Liver Transplantation | 34 participants |