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BREATHID Octanoate Breath Test With or Without Methacetin Breath Test for Correlation With Biopsy in NASH

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ClinicalTrials.gov Identifier: NCT02314026
Recruitment Status : Completed
First Posted : December 10, 2014
Results First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Exalenz Bioscience LTD.

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Non-Alcoholic Steatohepatitis
Interventions Device: Suspected NASH BreathID test with 13C-Octanoate
Device: Suspected NASH Breath test with 13C Methacetin
Enrollment 140
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Suspected NASH
Hide Arm/Group Description

13C-Octanoate, 13C-Methacetin

Suspected NASH BreathID test with 13C-Octanoate: Subject will have breath measured before and after ingestion of solution of 100 mg 13C Octanoate dissolved in 150 cc of water

Suspected NASH Breath test with 13C Methacetin: Subject will have breath measured before and after ingestion of solution of 75 mg 13C Methacetin dissolved in 150 cc of water

Period Title: Overall Study
Started 135
Completed 107
Not Completed 28
Reason Not Completed
Protocol Violation             28
Arm/Group Title Suspected NASH
Hide Arm/Group Description

13C-Octanoate, 13C-Methacetin

Suspected NASH BreathID test with 13C-Octanoate: Subject will have breath measured before and after ingestion of solution of 100 mg 13C Octanoate dissolved in 150 cc of water

Suspected NASH Breath test with 13C Methacetin: Subject will have breath measured before and after ingestion of solution of 75 mg 13C Methacetin dissolved in 150 cc of water

Overall Number of Baseline Participants 135
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 135 participants
53.4  (12.57)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 135 participants
Female
75
  55.6%
Male
60
  44.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 135 participants
Hispanic or Latino
29
  21.5%
Not Hispanic or Latino
106
  78.5%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 135 participants
Belgium 15
United States 102
United Kingdom 9
France 9
1.Primary Outcome
Title Number of Participants With Biopsy Proven Non-Alcoholic Steatohepatitis
Hide Description Non-Alcoholic Steatohepatitis (NASH) as determined by liver biopsy histology will be the comparator
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects that had a valid biopsy and performed both Octanoate and Methacetin Breath test
Arm/Group Title Suspected NASH
Hide Arm/Group Description:

13C-Octanoate, 13C-Methacetin

Suspected NASH BreathID test with 13C-Octanoate: Subject will have breath measured before and after ingestion of solution of 100 mg 13C Octanoate dissolved in 150 cc of water

Suspected NASH Breath test with 13C Methacetin: Subject will have breath measured before and after ingestion of solution of 75 mg 13C Methacetin dissolved in 150 cc of water

Overall Number of Participants Analyzed 107
Measure Type: Count of Participants
Unit of Measure: Participants
Definite NASH
74
  69.2%
Probable NASH
20
  18.7%
Absent of NASH
13
  12.1%
2.Primary Outcome
Title Liver Decompensation as Measured by Area Under Receiver Operating Curve
Hide Description Observe if breath tests correlate to clinical outcome of liver decompensation, including ascites, variceal bleeding, hepatic encephalopathy and spontaneous bacterial peritonitis.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Suspected NASH
Hide Arm/Group Description:

13C-Octanoate, 13C-Methacetin

Suspected NASH BreathID test with 13C-Octanoate: Subject will have breath measured before and after ingestion of solution of 100 mg 13C Octanoate dissolved in 150 cc of water

Suspected NASH Breath test with 13C Methacetin: Subject will have breath measured before and after ingestion of solution of 75 mg 13C Methacetin dissolved in 150 cc of water

Overall Number of Participants Analyzed 107
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Probability
0.852
(0.771 to 0.933)
3.Other Pre-specified Outcome
Title Number of Participants With Adverse Events
Hide Description A phone call will be made to each subject 48 hours after the last breath test to confirm that no adverse events related to breath test have been experienced.
Time Frame 48 hours from last breath test
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Suspected NASH
Hide Arm/Group Description:

13C-Octanoate, 13C-Methacetin

Suspected NASH BreathID test with 13C-Octanoate: Subject will have breath measured before and after ingestion of solution of 100 mg 13C Octanoate dissolved in 150 cc of water

Suspected NASH Breath test with 13C Methacetin: Subject will have breath measured before and after ingestion of solution of 75 mg 13C Methacetin dissolved in 150 cc of water

Overall Number of Participants Analyzed 135
Measure Type: Count of Participants
Unit of Measure: Participants
Possibly related adverse event
0
   0.0%
No possibly related reported adverse events
135
 100.0%
Time Frame Adverse events were collected for up to 36 months from enrollment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Suspected NASH
Hide Arm/Group Description

13C-Octanoate, 13C-Methacetin

Suspected NASH BreathID test with 13C-Octanoate: Subject will have breath measured before and after ingestion of solution of 100 mg 13C Octanoate dissolved in 150 cc of water

Suspected NASH Breath test with 13C Methacetin: Subject will have breath measured before and after ingestion of solution of 75 mg 13C Methacetin dissolved in 150 cc of water

All-Cause Mortality
Suspected NASH
Affected / at Risk (%)
Total   0/135 (0.00%)    
Hide Serious Adverse Events
Suspected NASH
Affected / at Risk (%) # Events
Total   1/135 (0.74%)    
Hepatobiliary disorders   
Acute cholecystitis * 1 [1]  1/135 (0.74%)  1
1
Term from vocabulary, MedDRA (10.0)
*
Indicates events were collected by non-systematic assessment
[1]
Acute cholecystitis
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Suspected NASH
Affected / at Risk (%) # Events
Total   5/135 (3.70%)    
Gastrointestinal disorders   
Abdominal pain * 1 [1]  1/135 (0.74%)  1
Nausea * 1 [2]  2/135 (1.48%)  2
Nervous system disorders   
Dizziness * 1 [3]  1/135 (0.74%)  1
Headache * 1 [4]  1/135 (0.74%)  1
1
Term from vocabulary, MedDRA (21.1)
*
Indicates events were collected by non-systematic assessment
[1]
Patient suffered from abdominal pain and cramping
[2]
Patient suffered from nausea on day of test
[3]
Patient suffered from dizziness
[4]
Patient suffered from headache on day of test
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
Layout table for Results Point of Contact information
Name/Title: Clinical trial manager
Organization: Exalenz Bioscience
Phone: 97289737513
EMail: avrahamh@exalenz.com
Layout table for additonal information
Responsible Party: Exalenz Bioscience LTD.
ClinicalTrials.gov Identifier: NCT02314026    
Other Study ID Numbers: NASH-EX-1114
First Submitted: December 4, 2014
First Posted: December 10, 2014
Results First Submitted: February 7, 2019
Results First Posted: March 19, 2019
Last Update Posted: March 19, 2019