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

Meridian Bioscience

Status: Completed

Conditions: Chronic Liver Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT02084160

HIS-FU-EX-1213

Details and patient eligibility

About

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.

Full 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.

Enrollment: 579 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

None

Trial design

579 participants in 1 patient group

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

Description:

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