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

Chronic Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02084160
• Other study ID #: HIS-FU-EX-1213
• Status: Completed
• Start date: March 2014
• Est. completion date: November 2018

Study information

• Verified date: December 2022
• Source: Meridian Bioscience, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 579
• Est. completion date: November 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

None

Related Conditions & MeSH terms

• Chronic Liver Disease
• Liver Diseases

Locations

Country	Name	City	State
Israel	Hadassah Medical Origanzation	Jerusalem
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Henry Ford Health System	Detroit	Michigan
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Meridian Bioscience, Inc.

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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: 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