Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BreathID · 1 trial · 1 indication
Patient dies of liver-related causes within 1 year of study entry
| Arm | Type | Description |
|---|---|---|
| Laboratory assay | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| 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. |
Inclusion criteria: 1. Being considered for placement or already on the liver transplantation waiting list 2. Cirrhosis caused by any cause of chronic liver disease. 3. Age \> 18 years Exclusion criteria: 1. Known or suspected hepatocellular carcinoma 2. Prior TIPS placement 3. Severe congestive ...
BreathID is an investigational diagnostic device being studied for use in cirrhosis, specifically to predict liver failure in patients with cirrhosis. It is a methacetin breath test that is being evaluated in a Phase 3 clinical trial. The device is not yet approved and remains in clinical development.
BreathID is a breath test that uses methacetin to evaluate liver function. It is designed to predict liver failure in patients with cirrhosis by measuring the metabolism of methacetin, which is processed by the liver. The test is being studied as a non-invasive diagnostic tool for assessing liver function.
BreathID is being developed by Meridian Bioscience Inc, a company traded on the NASDAQ under the ticker VIVO. The company is conducting a Phase 3 clinical trial to evaluate the device for predicting liver failure in patients with cirrhosis.
BreathID is in Phase 3 clinical development. It is an investigational device and has not been approved by regulatory authorities. The Phase 3 trial, which has been completed, enrolled 165 patients with cirrhosis to evaluate the methacetin breath test for predicting liver failure.
BreathID has one completed Phase 3 clinical trial, NCT01157845, titled 'Use of Methacetin Breath Test to Predict Liver Failure in Patients With Cirrhosis.' The trial enrolled 165 patients with cirrhosis in the United States and Israel. It was an uncontrolled, non-randomized study that included biomarker selection.