NCT02084160

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 579 (actual)
• Sponsor: Meridian Bioscience, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Chronic Liver Disease

Timeline

• Start date: 2014-03-01
• Primary completion: 2018-10-01
• Completion: 2018-11-01
• First posted: 2014-03-11
• Last updated: 2022-12-20
• Results posted: 2019-09-27

Locations

4 sites across 2 countries: United States, Israel