Development of a Breath Test for Monitoring Patients With Liver Disease

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the safety and efficacy of the Oridion Breath ID machine in monitoring liver metabolic functions.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virginia Commonwealth University
• Collaborator: Oridion

Criteria

Inclusion Criteria:

• Adult men and women (age 18+)

• Liver histology consistent with NAFLD/NASH performed within the past 24 months

• Patients with cirrhosis must have ultrasound, computed tomography (CT) scan, or magnetic resonance imaging (MRI) examination of liver performed within the previous 6 months demonstrating no evidence for hepatocellular carcinoma

Exclusion Criteria:

• Any liver disease beyond NAFLD/NASH

• Severe congestive heart failure

• Severe pulmonary hypertension

• Chronic renal insufficiency defined by a serum creatinine above normal

• Uncontrolled diabetes mellitus

• Any autoimmune disorder which is currently being treated with immune suppressive medication

• Proven or suspected hepatocellular carcinoma

• Previous surgical bypass surgery for morbid obesity

• Extensive small bowel resection

• Patients currently receiving total parenteral nutrition

• Recipients of any organ transplant

• Women who are pregnant

• Patients who, in the opinion of the investigator, should not be enrolled in this study