Trial Outcomes & Findings for BreathID 13C-Methacetin Breath Test for Detecting Cirrhosis (NCT NCT00736840)
NCT ID: NCT00736840
Last Updated: 2023-01-12
Results Overview
"Hepatic Impairment Score" (HIS) is a score based on breath test parameters and demographic parameters of the subject being tested. A HIS value greater than 0.14 would mean that the subject is likely to be cirrhotic (based on biopsy result as the gold standard). The HIS is a probability score,i.e. ranges from 0 to 1, where 0 would mean the lowest probability of having liver cirrhosis and 1 would be the highest probability of having liver cirrhosis. This would be compared to the actual biopsy result of cirrhosis detection as the gold standard.
COMPLETED
PHASE3
414 participants
Study day 1 after a 1 hour test
2023-01-12
Participant Flow
414 subjects were collected in 11 sites; 8 in the United states and 3 in Israel. Recruitment began in August 2008 and was completed Sep 2009.
4 sites, 1 in Israel and 3 in the United States recruited most of the subjects. Patients with chronic liver disease and recent biopsies performed or planned were approached. Exclusion criteria focused mostly on issues that would affect accuracy of breath test.
Participant milestones
| Measure |
CLD (Chronic Liver Disease)
Chronic liver disease subjects with recent (within 3 months)liver biopsy will be tested with the 13C methacetin breath test, which entails connecting the subject via a nasal cannula to the BreathID analyzer and after measuring baseline breath, have the subject drink 150cc of aqueous solution which contains 75 mg of 13C -labeled methacetin (Intervention material)
|
|---|---|
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Overall Study
STARTED
|
414
|
|
Overall Study
COMPLETED
|
401
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
CLD (Chronic Liver Disease)
Chronic liver disease subjects with recent (within 3 months)liver biopsy will be tested with the 13C methacetin breath test, which entails connecting the subject via a nasal cannula to the BreathID analyzer and after measuring baseline breath, have the subject drink 150cc of aqueous solution which contains 75 mg of 13C -labeled methacetin (Intervention material)
|
|---|---|
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Overall Study
Lost to Follow-up
|
13
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Baseline Characteristics
BreathID 13C-Methacetin Breath Test for Detecting Cirrhosis
Baseline characteristics by cohort
| Measure |
CLD (Chronic Liver Disease)
n=414 Participants
Chronic liver disease subjects with recent (within 3 months)liver biopsy will be tested with the 13C methacetin breath test, which entails connecting the subject via a nasal cannula to the BreathID analyzer and after measuring baseline breath, have the subject drink 150cc of aqueous solution which contains 75 mg of 13C -labeled methacetin (Intervention material)
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
374 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
39 Participants
n=5 Participants
|
|
Age, Continuous
|
51.3 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
178 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
236 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
327 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
87 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Study day 1 after a 1 hour testPopulation: The primary efficacy was conducted on all evaluable subject data in the full analysis (FA)set with biopsy confirmed cirrhosis.
"Hepatic Impairment Score" (HIS) is a score based on breath test parameters and demographic parameters of the subject being tested. A HIS value greater than 0.14 would mean that the subject is likely to be cirrhotic (based on biopsy result as the gold standard). The HIS is a probability score,i.e. ranges from 0 to 1, where 0 would mean the lowest probability of having liver cirrhosis and 1 would be the highest probability of having liver cirrhosis. This would be compared to the actual biopsy result of cirrhosis detection as the gold standard.
Outcome measures
| Measure |
CLD (Chronic Liver Disease)
n=146 Participants
Chronic liver disease subjects with recent (within 3 months)liver biopsy will be tested with the 13C methacetin breath test, which entails connecting the subject via a nasal cannula to the BreathID analyzer and after measuring baseline breath, have the subject drink 150cc of aqueous solution which contains 75 mg of 13C -labeled methacetin (Intervention material)
|
|---|---|
|
Number of Subjects With Likelihood of Cirrhosis Based on "Hepatic Impairment Score" (HIS)
|
146 Participants
Interval 66.07 to 80.88
|
SECONDARY outcome
Timeframe: At study day 1 after 1 hour testThe AUC represents a summary measure of the ROC curve and is the accuracy of the HIS in detecting cirrhosis compared to the gold standard of biopsy.
Outcome measures
| Measure |
CLD (Chronic Liver Disease)
n=414 Participants
Chronic liver disease subjects with recent (within 3 months)liver biopsy will be tested with the 13C methacetin breath test, which entails connecting the subject via a nasal cannula to the BreathID analyzer and after measuring baseline breath, have the subject drink 150cc of aqueous solution which contains 75 mg of 13C -labeled methacetin (Intervention material)
|
|---|---|
|
AUC of ROC (Area Under Receiver Operating Characteristic Curve)
|
0.785 Probability
Interval 0.737 to 0.834
|
Adverse Events
CLD (Chronic Liver Disease)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Any manuscript, abstract or other publication or presentation of results or information arising from the study (including ancillary studies involving trial patients) must be prepared in conjunction with Exalenz. Such materials must be submitted to Exalenz for review and comment at least 30 days prior to submission for publication or presentation.
- Publication restrictions are in place
Restriction type: OTHER