BreathID 13C-Methacetin Breath Test for Detecting Cirrhosis

Completed · Phase 3

Conditions studied: Chronic Liver Disease

In brief

This trial is a pivotal trial to validate the use of a 13 C labeled substrate called methacetin and the BreathID automatic breath testing system, for determination of cirrhosis in patients with chronic liver disease.

Key facts

Study ID

NCT00736840

Run by

Meridian Bioscience, Inc.

People needed

414

Starts

2008-08-01

Expected to finish

2009-09-01

Last updated by the study team

2023-01-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >18 with chronic liver disease

You may not qualify if…

• Patients that are taking hepatotoxin drug.
• Patient with severe congestive heart failure
• Patient with severe pulmonary hypertension
• Patient with uncontrolled diabetes mellitus
• Patient with previous surgical bypass surgery for morbid obesity
• Patient with extensive small bowel resection
• Patient currently receiving total parenteral nutrition
• Patient is a recipients of any organ transplant
• Patients that received any anti-viral treatment within the past year
• Women who are pregnant
• Patient allergic to acetaminophen (such as Tylenol or any other related medications)
• Patient with history of chronic obstructive pulmonary disease or symptomatic bronchial asthma
• Patients unable to sign informed consent
• Patients that based on the opinion of the investigator should not be enrolled into this study
• Patients that are participating in other clinical trials evaluating experimental treatments or procedures

Where it is running

• Cedars Sinai Medical Center — Los Angeles, California, United States
• Henry Ford Health Sytem — Detroit, Michigan, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University of Pennsylvania Health System — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• St Luke's Episcopal Hospital, Baylor College of Medicine — Houston, Texas, United States
• Inova Helath System — Falls Church, Virginia, United States
• Virginia Commonwealth University Medical Center — Richmond, Virginia, United States
• Soroka Medical Center — Beersheba, Israel
• Carmel Medical Center — Haifa, Israel
• Hadassah Medical Center — Jerusalem, Israel

Full record on ClinicalTrials.gov

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