Development of a Breath Test for Monitoring Patients With Liver Disease

NCT00244569 | Completed Phase 3

• 1 other identifier: OBID-2005-VCU
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fatty Liver; Cirrhosis

Keywords

Nonalcoholic Fatty Liver Disease; Nonalcoholic Steatohepatitis; Liver Function; Metabolism; Cirrhosis; Fibrosis; Liver

Outcome Measures

Primary Outcomes (2)

• The mean and standards of results obtained from the Breath ID system for each of the 3 groups of patients with nonalcoholic fatty liver disease/nonalcoholic steatohepatitis (NAFLD/NASH) will be compared by chi squared analysis.

• A p value of 0.05 or less will be considered significant.

Secondary Outcomes (1)

• Receiver-operator curves will be developed to compare the results of the Breath ID to each histologic group of patients studied. A p value of 0.05 will be considered significant.

Interventions

13C-Methacetin DRUG

Breath ID Machine DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Oridion: collaborator

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

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MeSH Terms

Conditions

Fatty Liver; Fibrosis; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mitchell L. Shiffman, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2005
• First Posted: October 26, 2005
• Study Start: September 1, 2005
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: March 20, 2017

Record last verified: 2017-03

Locations

US (1)