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

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ClinicalTrials.gov Identifier: NCT01157845
Recruitment Status : Completed
First Posted : July 7, 2010
Results First Posted : March 4, 2014
Last Update Posted : May 16, 2014
Sponsor:
Collaborator:
Exalenz Bioscience LTD.
Information provided by (Responsible Party):
Virginia Commonwealth University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Cirrhosis
Intervention Device: BreathID (Methacetin breath test)
Enrollment 165
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Laboratory Assay
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 165
Completed 130
Not Completed 35
Reason Not Completed
Lost to Follow-up             5
Withdrawal by Subject             12
Physician Decision             3
Protocol Violation             13
Study was ended             1
Device malfunction             1
Arm/Group Title Laboratory Assay
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 165
Hide Baseline Analysis Population Description
All chronic liver disease patients with clinically proven cirrhosis and candidates for liver transplant.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 165 participants
55.7  (10.43)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 165 participants
Female
59
  35.8%
Male
106
  64.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 165 participants
Hispanic or Latino
2
   1.2%
Not Hispanic or Latino
163
  98.8%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 165 participants
United States 99
Israel 66
Chronic Liver Disease Etiology  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 165 participants
Alcoholic Liver Disease 22
Cholestatic 16
Cryptogenic cirrhosis 17
Hepatitis B 5
Hepatitis C 75
Fatty LIver 19
Other 11
1.Primary Outcome
Title Mortality From Liver Failure
Hide Description Patient dies of liver-related causes within 1 year of study entry
Time Frame 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Laboratory Assay
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 165
Measure Type: Number
Unit of Measure: participants
11
2.Secondary Outcome
Title Liver Transplantation
Hide Description Patient experiences complications of liver failure within 1 year of study entry and undergoes liver transplantation
Time Frame 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Laboratory Assay
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 165
Measure Type: Number
Unit of Measure: participants
34
Time Frame [Not Specified]
Adverse Event Reporting Description No breath test related adverse events reported.
 
Arm/Group Title Laboratory Assay
Hide Arm/Group Description 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.
All-Cause Mortality
Laboratory Assay
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Laboratory Assay
Affected / at Risk (%) # Events
Total   107/165 (64.85%)    
Blood and lymphatic system disorders   
Hyponatremia *  3/165 (1.82%)  3
Gastrointestinal disorders   
Bowel Resection *  1/165 (0.61%)  2
Hepatobiliary disorders   
Transplantation * [1]  34/165 (20.61%)  34
Death * [2]  11/165 (6.67%)  11
Abdominal pain * [3]  8/165 (4.85%)  11
Hepatic Encephelopathy * [4]  6/165 (3.64%)  13
Ascites * [5]  5/165 (3.03%)  6
GI Bleeding * [6]  5/165 (3.03%)  5
SBP (spontaneous bacterial peritonitis) * [7]  8/165 (4.85%)  13
Cellulitis *  2/165 (1.21%)  2
Fluid in respiratory tract *  1/165 (0.61%)  1
Infections and infestations   
Sepsis * [8]  7/165 (4.24%)  9
Renal and urinary disorders   
Renal failure * [9]  5/165 (3.03%)  6
Urinary tract infection *  1/165 (0.61%)  1
Respiratory, thoracic and mediastinal disorders   
Asthma *  1/165 (0.61%)  1
Chest pain *  2/165 (1.21%)  2
Surgical and medical procedures   
Liver related procedure-TIPS * [10]  5/165 (3.03%)  5
Band Ligation Procedure * [11]  2/165 (1.21%)  2
RFA * [12]  1/165 (0.61%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Patients in this trial are candidates for liver transplant. When there is a sudden change for the worse in their condition, they may be prioritized for transplantation/
[2]
Some patients waiting for a liver transplant will die before they find a matching liver
[3]
Indirectly related- to- liver ailments may occur in patients with advanced liver disease.
[4]
Lack in full cognitive abilities is common in patients with advanced liver disease.
[5]
Ascites ( collection of fluid) is common in patients with advanced liver disease
[6]
GI bleeding (varices) is common in patients with advanced liver disease
[7]
Common in advanced cirrhotics
[8]
The lack of liver functionality in cirrhotic patients may lead to certain severe events such as sepsis
[9]
The lack of liver functionality in cirrhotic patients may lead to certain severe events such as renal failure
[10]
The patients with advanced liver disease are occasionally hospitalized for preventative treatments such as TIPS (Transjugular intrahepatic portosystemic shunt)
[11]
The patients with advanced liver disease are occasionally hospitalized for preventative treatments such as band ligation
[12]
The patients with advanced liver disease are occasionally hospitalized for preventative treatments such as RFA (radio frequency ablation)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Laboratory Assay
Affected / at Risk (%) # Events
Total   92/165 (55.76%)    
Blood and lymphatic system disorders   
Blood related disorders *  5/165 (3.03%)  5
Gastrointestinal disorders   
Diarrhea *  8/165 (4.85%)  9
Abdominal Pain *  5/165 (3.03%)  16
Vomiting *  1/165 (0.61%)  1
Melena *  1/165 (0.61%)  1
Other Gastrointestinal Disorders * [1]  1/165 (0.61%)  1
General disorders   
Hernia *  2/165 (1.21%)  3
Assorted Pains (excluding abdominal) *  13/165 (7.88%)  19
Fatigue *  3/165 (1.82%)  3
Fluid accumulation-edema *  2/165 (1.21%)  2
Itching *  5/165 (3.03%)  5
Others * [2]  6/165 (3.64%)  6
Pleural Effusion *  1/165 (0.61%)  1
Infections and infestations   
Infections * [3]  5/165 (3.03%)  5
Musculoskeletal and connective tissue disorders   
Hip Fracture *  1/165 (0.61%)  1
Hip replacement *  1/165 (0.61%)  1
Difficulty ambulating *  2/165 (1.21%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Malignancies *  3/165 (1.82%)  3
Nervous system disorders   
Headaches, Migraines, Dizziness *  6/165 (3.64%)  12
Seizure *  2/165 (1.21%)  2
Psychiatric disorders   
Depression *  3/165 (1.82%)  3
Lightheadedness *  1/165 (0.61%)  1
Anxiety *  1/165 (0.61%)  1
Suicidal thoughts *  1/165 (0.61%)  1
Other psychiatric disorders * [4]  1/165 (0.61%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumonia *  1/165 (0.61%)  1
Surgical and medical procedures   
Out-patient procedure-Paracentesis *  11/165 (6.67%)  64
*
Indicates events were collected by non-systematic assessment
[1]
Non-specified disorders
[2]
Not specified
[3]
Various infections not liver related and not specified
[4]
Unspecified psychiatric disorders
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: R. Todd Stravitz
Organization: Virginia Commonwealth University
Phone: 804-828-8514
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01157845     History of Changes
Other Study ID Numbers: VirginiaCU HM12041
First Submitted: July 2, 2010
First Posted: July 7, 2010
Results First Submitted: January 17, 2014
Results First Posted: March 4, 2014
Last Update Posted: May 16, 2014