13C-Methacetin Breath Test for the Prediction of Outcome in in ALI or ALF
Status:
Completed
Trial end date:
2019-09-18
Target enrollment:
Participant gender:
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.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
University of Texas Southwestern Medical Center William Lee
Collaborators:
Exalenz Bioscience LTD. Medical University of South Carolina National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) University of Michigan