Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-01-05 @ 1:33 AM
Study NCT ID:
NCT02084160
Status:
COMPLETED
Last Update Posted:
2022-12-20
First Post:
2014-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prediction Value of the BreathID 13C-Methacetin Breath Test for Hepatic Decompensation
Sponsor:
Meridian Bioscience, Inc.
Organization:
Study Overview
Official Title:
The Prediction Value of the BreathID 13C-Methacetin Breath Test for Hepatic Decompensation; a Retrospective Analysis
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: