N/A
N=579
Prediction Value of the BreathID 13C-Methacetin Breath Test for Hepatic Decompensation
Chronic Liver Disease
Bottom Line
View on ClinicalTrials.gov: NCT02084160 ↗Enrolled (actual)
579
Serious AEs
—
Results posted
Sep 2019
Primary outcome: Primary: Hepatic Decompensation Event — 324 number of events
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Meridian Bioscience, Inc.
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hepatic Decompensation Event |
324 | — |
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.
Eligibility Criteria
Inclusion Criteria
All subjects that aere enrolled in the previous Exalenz trial HIS-EX-408 or PLT-BID-1108
Exclusion Criteria
None
Data sourced from ClinicalTrials.gov (NCT02084160). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.