The ALF-MBT protocol is for a multicenter, open label, non-randomized study to determine the
value of Breath Identification® (BreathID®) Acute Liver Failure 13C-Methacetin Breath Test
System in predicting the outcome of patients diagnosed with acute liver failure who meet
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 on all patients 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.
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.