Prediction Value of the BreathID 13C-Methacetin Breath Test for Hepatic Decompensation

Completed

• Conditions: Chronic Liver Disease

• Registration Number: NCT02084160
• Lead Sponsor: Meridian Bioscience, Inc.

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.

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-03-09
• Study First Submitted QC: 2014-03-09
• Study First Posted: 2014-03-11
• Primary Completion: 2018-10
• Study Completion: 2018-11
• Results First Submitted: 2019-08-26
• Results First Submitted QC: 2019-09-26
• Results First Posted: 2019-09-27
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-19
• Last Update Posted: 2022-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 579

Inclusion Criteria

All subjects that aere enrolled in the previous Exalenz trial HIS-EX-408 or PLT-BID-1108

Exclusion Criteria

None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

Hadassah Medical Origanzation; 🇮🇱 Jerusalem, Israel

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States