NCT01157845

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2010

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 7, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

March 4, 2014

Completed
Last Updated

May 16, 2014

Status Verified

April 1, 2014

Enrollment Period

2.3 years

First QC Date

July 2, 2010

Results QC Date

January 17, 2014

Last Update Submit

April 29, 2014

Conditions

Cirrhosis

Outcome Measures

Primary Outcomes (1)

  • Mortality From Liver Failure

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

    1 year

Secondary Outcomes (1)

  • Liver Transplantation

    1 year

Study Arms (1)

Laboratory assay

EXPERIMENTAL
Device: BreathID (Methacetin breath test)

Interventions

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.

Also known as: BreathID (Exalenz Bioscience LTD)
Laboratory assay

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Virginia Commonwealth University Medical Center

Richmond, Virginia, 23298, United States

Location

Hadassah Medical Center

Jerusalem, Israel, 91120, Israel

Location

Related 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. doi: 10.1111/j.1365-2036.2005.02317.x.

    PMID: 15679768BACKGROUND

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
R. Todd Stravitz
Organization
Virginia Commonwealth University
rstravit@vcu.edu
804-828-8514

Study Officials

  • Richard T Stravitz, MD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

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

July 2, 2010

First Posted

July 7, 2010

Study Start

March 1, 2010

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

May 16, 2014

Results First Posted

March 4, 2014

Record last verified: 2014-04

Locations

US(3)IL(1)