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c13 methacetin with breath analyzer · 1 trial · 1 indication
"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.
| Arm | Type | Description |
|---|---|---|
| CLD (chronic liver disease) | OTHER | Chronic liver disease subjects with recent biopsy will be tested with a breath tests using a 13C enriched substrate metabolized by their liver |
| Name | Type | Description |
|---|---|---|
| c13 methacetin solution with breath analyzer | DEVICE | Carbon 13 methacetin 75mg dissolved in 150 ml is given to the subject and metabolism is measured by a breath analyzer after decomposed by the liver |
Inclusion Criteria: * Age \>18 with chronic liver disease Exclusion Criteria: * Patients that are taking hepatotoxin drug. * Patient with severe congestive heart failure * Patient with severe pulmonary hypertension * Patient with uncontrolled diabetes mellitus * Patient with previous surgical byp...
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c13 methacetin with breath analyzer is used for detecting cirrhosis in patients with chronic liver disease. It is an investigational diagnostic test that measures liver function by analyzing breath samples after administration of 13C-methacetin. The test is being developed as a non-invasive alternative to liver biopsy for assessing cirrhosis.
c13 methacetin with breath analyzer is being developed by Meridian Bioscience Inc, a company traded on the stock exchange under the ticker VIVO. The company is conducting clinical trials to evaluate the diagnostic accuracy of this breath test for detecting cirrhosis in patients with chronic liver disease.
c13 methacetin with breath analyzer is in Phase 3 clinical development. It is an investigational diagnostic test and has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the results will be used to support potential regulatory submissions for marketing approval.
c13 methacetin with breath analyzer has one completed Phase 3 clinical trial registered as NCT00736840. The trial, titled 'BreathID 13C-Methacetin Breath Test for Detecting Cirrhosis', enrolled 414 participants with chronic liver disease. It was conducted in the United States and Israel, and included adults aged 18 years and older.
c13 methacetin with breath analyzer is not FDA approved. It is an investigational diagnostic test currently in Phase 3 clinical development. The completed Phase 3 trial evaluated its ability to detect cirrhosis in patients with chronic liver disease, but regulatory approval has not been granted yet.