The Prediction Value of the BreathID 13C-Methacetin Breath Test for Hepatic Decompensation; a Retrospective Analysis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Liver Disease
- Sponsor
- Meridian Bioscience, Inc.
- Enrollment
- 579
- Locations
- 4
- Primary Endpoint
- Hepatic Decompensation Event
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The objectives of this study are:
- To evaluate the ability of the Methacetin Breath Test (MBT) to detect hepatic decompensation events
- To evaluate the relationship between liver Biopsy and clinical outcome and show that the MBT has a better predictive ability of clinical outcome than liver biopsy.
- To evaluate the ability of the MBT to predict each of the individual liver related complications.
Detailed Description
Exalenz has previously gathered information in a previous study on patients with chronic liver disease including the methacetin breath test. Several years later, the company wishes to investigate this group of subjects and see retrospectively if the breath test was a predictor of complications related to their liver disease.
Investigators
Eligibility Criteria
Inclusion Criteria
- •All subjects that aere enrolled in the previous Exalenz trial HIS-EX-408 or PLT-BID-1108
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Hepatic Decompensation Event
Time Frame: 5 years
Hepatic decompensation is defined as the occurrence of at least one of the following events in the time frame between the last 13C Methacetin Breath Test (MBT) to the time of data collection: 1. Death (liver related) 2. Transplantation (cadaveric and living donors) 3. Ascites 4. HE (Hepatic Encephalopathy) 5. Newly diagnosed varices or variceal bleeding 6. SBP (spontaneous bacterial peritonitis) 7. HRS (Hepatorenal syndrome) 8. HCC (hepatocellular carcinoma) 9. Increase in CTP (Child Turcotte Pugh) Score by 3 points 10. Increase in MELD score by 5 points