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Completed

NCT Number: NCT02084160

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

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.

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Key information

Conditions

Chronic Liver Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hadassah Medical Origanzation, Jerusalem, Israel

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

None

Treatment and study plan

Primary outcomes

  1. Hepatic Decompensation Event

    Time frame: 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:

    • 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

Sponsors and collaborators

Lead sponsor

Meridian Bioscience, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Mar 11, 2014
Registry last updated
Dec 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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