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Completed

NCT Number: NCT01157845

Use of Methacetin Breath Test to Predict Liver Failure in Patients With Cirrhosis

The methacetin breath test (MBT) is a non-invasive liver function test which measures the ability of the liver to metabolize a tracer dose of a compound to carbon dioxide, which is exhaled. The study hypothesis is that measurement of the MBT will allow earlier detection of a decline in liver function in patients with cirrhosis who are awaiting liver transplantation.

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Key information

Conditions

Cirrhosis Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hadassah Medical Center, Jerusalem, Israel

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Being considered for placement or already on the liver transplantation waiting list
  • Cirrhosis caused by any cause of chronic liver disease.
  • Age > 18 years

Exclusion criteria

  • Known or suspected hepatocellular carcinoma
  • Prior TIPS placement
  • Severe congestive heart failure
  • Severe pulmonary hypertension
  • Uncontrolled diabetes mellitus (HBA1C >9.5%)
  • Any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication.
  • Previous surgical bypass surgery for morbid obesity (BMI >45)
  • Extensive small bowel resection
  • Patients currently receiving total parenteral nutrition if they have contraindications to oral drugs
  • Women who are pregnant
  • Patients who are allergic to acetaminophen/ paracetamol or any other related medications
  • Patients with an acute current exacerbation of chronic obstructive pulmonary disease or bronchial asthma.
  • Patients that are taking hepatotoxin drugs
  • Patient, based on the opinion of the investigator, should not be enrolled into this study
  • Patient is unable or unwilling to sign informed consent.
  • Patients that are participating in other clinical trials evaluating experimental treatments or procedures

Treatment and study plan

BreathID (Methacetin breath test)

Device

13C-labeled methacetin (75 mg) is given to the patient by mouth in a small volume of water, and expired 13C-labeled carbon dioxide is measured from a nasal cannula.

Other names: BreathID (Exalenz Bioscience LTD)

Primary outcomes

  1. Mortality From Liver Failure

    Time frame: 1 year

    Patient dies of liver-related causes within 1 year of study entry

Secondary outcomes

  1. Liver Transplantation

    Time frame: 1 year

    Patient experiences complications of liver failure within 1 year of study entry and undergoes liver transplantation

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • Meridian Bioscience, Inc.

Registry information

Official study title

Use of the BreathID Methacetin Breath Test to Assess Hepatic Metabolic Reserve and to Predict Hepatic Decompensation in Patients Awaiting Liver Transplantation

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jul 7, 2010
Registry last updated
May 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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