13C-Methacetin Breath Test for the Prediction of Outcome in in ALI or ALF (NCT02786836) | Clinical Trial Compass
CompletedPhase 2/3
13C-Methacetin Breath Test for the Prediction of Outcome in in ALI or ALF
United States76 participantsStarted 2016-06-10
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
âś“. Adult men or women (18-80 years of age)
✓. Severe acute liver injury not related to acetaminophen overdose: INR ≥2.0; no evidence of HE
✓. Acute liver failure: INR ≥1.5; presence of any degree of HE
âś“. Duration of illness \<26 weeks
âś“. Enrolled into the ALFSG Registry.
âś“. Written informed consent from the patient or patient's legally authorized representative or family member as defined in the Federal Register Number 21 Congressional Federal Register (CFR)50.3(m)
Exclusion criteria
âś•. Evidence of pre-existing chronic liver disease
âś•. Pre-existing New York Heart Association stage III/IV heart failure
âś•. Evidence of pre-existing chronic renal failure
âś•. Chronic hemodialysis prior to hospital admission
What they're measuring
1
Peak Percent Dose Recovery (PDR) Value
Timeframe: Days 1 and 21
Trial details
NCT IDNCT02786836
SponsorUniversity of Texas Southwestern Medical Center
âś•. Evidence of cirrhosis (unless clinically acute Wilson disease or autoimmune non-APAP ALI or ALF)
âś•. Severe obstructive lung disease (FEV1 \<50% of predicted on previous spirometry)
✕. Severe shock, defined as mean arterial pressure (MAP) \<70 mmHg despite \>15 µg/kg/min dopamine, \>0.1 µg/kg/min epinephrine, or \>0.1 norepinephrine µg/kg/min