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

NCT ID: NCT02084160

Last Updated: 2022-12-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

579 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2018-11-30

Brief Summary

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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

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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.

Conditions

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Chronic Liver Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meridian Bioscience, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Taufick Chori, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

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Henry Ford Health System

Detroit, Michigan, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Hadassah Medical Origanzation

Jerusalem, , Israel

Site Status

Countries

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United States Israel

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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HIS-FU-EX-1213

Identifier Type: -

Identifier Source: org_study_id