Status:
COMPLETED
Use of Methacetin Breath Test to Predict Liver Failure in Patients With Cirrhosis
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
Meridian Bioscience, Inc.
Conditions:
Cirrhosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Being considered for placement or already on the liver transplantation waiting list
- Cirrhosis caused by any cause of chronic liver disease.
- Age \> 18 years
- Exclusion criteria:
- 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.
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT01157845
Start Date
March 1 2010
End Date
July 1 2012
Last Update
May 16 2014
Active Locations (4)
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1
Henry Ford Health System
Detroit, Michigan, United States, 48202
2
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
3
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States, 23298
4
Hadassah Medical Center
Jerusalem, Israel, Israel, 91120