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

The Prediction Value of the BreathID 13C-Methacetin Breath Test for Hepatic Decompensation; a Retrospective Analysis

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.

Study Overview

• Status: Completed
• Conditions: Chronic Liver Disease

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 Type: Observational
• Enrollment (Actual): 579

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel
    • Hadassah Medical Origanzation
• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Virginia
    • Richmond, Virginia, United States
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Chronic liver disease subjects from previous Exalenz trial "HIS-EX-408"

Description

Inclusion Criteria:

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

Exclusion Criteria:

None

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
CLD from HIS-EX-408/PLT-BID-1108; Chronic liver disease subjects from previous Exalenz trial "HIS-EX-408" and PLT-BID1108

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: Death (liver related); Transplantation (cadaveric and living donors); Ascites; HE (Hepatic Encephalopathy); Newly diagnosed varices or variceal bleeding; SBP (spontaneous bacterial peritonitis); HRS (Hepatorenal syndrome); HCC (hepatocellular carcinoma); Increase in CTP (Child Turcotte Pugh) Score by 3 points; Increase in MELD score by 5 points	5 years

Collaborators and Investigators

• Sponsor: Meridian Bioscience, Inc.
• Investigators: Principal Investigator: Taufick Chori, MD, Hadassah Medical Organization

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2014
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: March 9, 2014
• First Submitted That Met QC Criteria: March 9, 2014
• First Posted (Estimate): March 11, 2014

Study Record Updates

• Last Update Posted (Actual): December 20, 2022
• Last Update Submitted That Met QC Criteria: December 19, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: HIS-FU-EX-1213