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

Status:	Completed
Conditions:	Gastrointestinal
Therapuetic Areas:	Gastroenterology
Healthy:	No
Age Range:	18 - Any
Updated:	11/30/2018
Start Date:	March 2014
End Date:	November 2018

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.

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.

Inclusion Criteria:

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

Exclusion Criteria:

We found this trial at

sites

Virginia Commonwealth University

Richmond, Virginia 23298

(804) 828-0100