Chronic Liver Disease
Conditions
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.
Interventions
None listed
Sponsors
Meridian Bioscience, Inc.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All subjects that aere enrolled in the previous Exalenz trial HIS-EX-408 or PLT-BID-1108
Exclusion criteria
None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hepatic Decompensation Event | 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 |
Countries
Israel, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| CLD From HIS-EX-408/PLT-BID-1108 Chronic liver disease subjects from previous Exalenz trial HIS-EX-408 and PLT-BID1108 | 579 |
| Total | 579 |
Baseline characteristics
| Characteristic | CLD From HIS-EX-408/PLT-BID-1108 | — |
|---|---|---|
| Age, Continuous | 52.55 years STANDARD_DEVIATION 10.67 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Israel | 161 Participants | — |
| Region of Enrollment United States | 418 Participants | — |
| Sex: Female, Male Female | 237 Participants | — |
| Sex: Female, Male Male | 342 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Hepatic Decompensation Event
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
Time frame: 5 years
Population: Patients with advanced chronic liver disease
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CLD From HIS-EX-408/PLT-BID-1108 | Hepatic Decompensation Event | 324 number of events |