At a glance
ClinicalIndex Comparison Record- ✓Adult aged 18-80 years
- ✓Severe acute liver injury with INR ≥2.0 and no hepatic encephalopathy, OR acute liver failure with INR ≥1.5 and any degree of hepatic encephalopathy
- ✓Illness duration <26 weeks
- ✓Enrolled in ALFSG Registry
- ✕Pre-existing chronic liver disease or cirrhosis (except acute Wilson disease or autoimmune non-APAP ALI/ALF)
- ✕Pre-existing NYHA stage III/IV heart failure
- ✕Pre-existing chronic renal failure or chronic hemodialysis prior to admission
- ✕Severe obstructive lung disease (FEV1 <50% predicted)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
13C-Methacetin Breath Test for the Prediction of Outcome in in Acute Liver Injury or Acute Liver Failure
In Brief
A Phase 3 clinical trial evaluating 13C-Methacetin for Acute Liver Failure. Completed, enrolled 76 participants across 11 sites.
Detailed Summary
The ALFSG-MBT protocol is for a multicenter, open label, non-randomized study to determine the value of Breath Identification® (BreathID®) N-(4-Methoxy-13C-phenyl)acetamide (13C-Methacetin) Breath Test System in predicting the outcome of patients diagnosed with severe acute liver injury that is not related to acetaminophen overdose or acute liver failure who meet inclusion/exclusion criteria. Up to 200 evaluable patients will be enrolled. An evaluable patient is one who has completed one or more breath tests for at least 30 minutes after administration of the 13C-Methacetin solution (test substrate). The Breath Test will be performed up to five times during the study period on all enrolled patients. The first Breath Test will be performed upon admission into the study (Day 1) and repeated on Days 2, 3, 5 and 7 provided no contra-indications are present. Each test continuously measures changes in the metabolism of the 13C-Methacetin in order to assess the improvement or deterioration in liver metabolic function about improvement or deterioration in liver metabolic function. If an enrolled non-APAP ALI or ALF patient receives a liver transplant, is discharged /transferred from the hospital or dies prior to Day 7, additional Breath Tests will not be performed. Patients will be contacted for the Day 21 follow up (21 days after enrollment into the trial) to determine spontaneous survival, transplantation and occurrence of serious adverse events since the patient's last study treatment.
Study Details
Timeline
Interventions
The test substrate in this study, ¹³C-methacetin solution for single-use oral administration (75 mg in 150 ml purified water), is administered orally or via feeding tube, rapidly absorbed, exclusively metabolized by hepatic mixed function oxidase via O-demethylation, mainly by cytochrome P450 enzyme, subtype 1A2, into acetaminophen and formaldehyde. The formaldehyde is then transformed through two successive oxidative steps to ¹³carbon dioxide, the quantity of which is measured in exhaled breath as a ratio of 13C to 12C. The nasal or intubated breath sampling investigational device (ID) circuit continuously transports the breath sample from the patient to the BreathID® MCS device before and following administration of the 13C-methylacetanilide test substrate.