Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00736840 | BreathID 13C-Methacetin Breath Test for Detecting Cirrhosis | PHASE3 | COMPLETED | 414 | — | — | Aug 1, 2008 | Sep 1, 2009 | Jan 12, 2023 | 11 | United States, Israel |
"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...