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

NCT02084160 | Completed Results

• 1 other identifier: HIS-FU-EX-1213
• Study Type: observational
• Target: 579
• Locations: 2 countries
• Sites: 4

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.

Conditions

Chronic Liver Disease

Outcome Measures

Primary Outcomes (1)

• 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: 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

  5 years

Study Arms (1)

CLD from HIS-EX-408/PLT-BID-1108

Chronic liver disease subjects from previous Exalenz trial "HIS-EX-408" and PLT-BID1108

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Meridian Bioscience, Inc.: lead

Study Sites (4)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Virginia Commonwealth University

Richmond, Virginia, United States

Location

Hadassah Medical Origanzation

Jerusalem, Israel

Location

Results Point of Contact

• Title: Avrahm Hershkowitz/ Clinical Trial Manager
• Organization: Exalenz

avrahamh@exalenz.com

972-8-9737500

Study Officials

• Taufick Chori, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2014
• First Posted: March 11, 2014
• Study Start: March 1, 2014
• Primary Completion: October 1, 2018
• Study Completion: November 1, 2018
• Last Updated: December 20, 2022
• Results First Posted: September 27, 2019

Record last verified: 2022-12

Locations

IL (1); US (3)