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

Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01157845
• Other study ID #: VirginiaCU HM12041
• Status: Completed
• Phase: Phase 3
• First received: July 2, 2010
• Last updated: April 29, 2014
• Start date: March 2010
• Est. completion date: July 2012

Study information

• Verified date: April 2014
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

1. Being considered for placement or already on the liver transplantation waiting list

2. Cirrhosis caused by any cause of chronic liver disease.

3. Age > 18 years

Exclusion criteria:

1. Known or suspected hepatocellular carcinoma

2. Prior TIPS placement

3. Severe congestive heart failure

4. Severe pulmonary hypertension

5. Uncontrolled diabetes mellitus (HBA1C >9.5%)

6. Any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication.

7. Previous surgical bypass surgery for morbid obesity (BMI >45)

8. Extensive small bowel resection

9. Patients currently receiving total parenteral nutrition if they have contraindications to oral drugs

10. Women who are pregnant

11. Patients who are allergic to acetaminophen/ paracetamol or any other related medications

12. Patients with an acute current exacerbation of chronic obstructive pulmonary disease or bronchial asthma.

13. Patients that are taking hepatotoxin drugs

14. Patient, based on the opinion of the investigator, should not be enrolled into this study

15. Patient is unable or unwilling to sign informed consent.

16. Patients that are participating in other clinical trials evaluating experimental treatments or procedures

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cirrhosis
• Liver Cirrhosis

Intervention

Device:
• BreathID (Methacetin breath test)
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.

Locations

Country	Name	City	State
Israel	Hadassah Medical Center	Jerusalem
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Henry Ford Health System	Detroit	Michigan
United States	Virginia Commonwealth University Medical Center	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	Exalenz Bioscience LTD.

Countries where clinical trial is conducted

United States,  Israel, 

References & Publications (1)

Braden B, Faust D, Sarrazin U, Zeuzem S, Dietrich CF, Caspary WF, Sarrazin C. 13C-methacetin breath test as liver function test in patients with chronic hepatitis C virus infection. Aliment Pharmacol Ther. 2005 Jan 15;21(2):179-85. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality From Liver Failure	Patient dies of liver-related causes within 1 year of study entry	1 year	No
Secondary	Liver Transplantation	Patient experiences complications of liver failure within 1 year of study entry and undergoes liver transplantation	1 year	No