The Effect of Acetaminophen on Non-alcoholic Fatty Liver Disease Patients
Status:
Withdrawn
Trial end date:
2015-03-19
Target enrollment:
Participant gender:
Summary
In this first pilot study, we will examine the effects of acetaminophen dosing in adult
patients with NAFLD in comparison to the effects in a healthy control group. Both groups will
receive 3 grams (g) of acetaminophen, the maximum recommended daily dose, daily for 14 days.
We hypothesize that NAFLD patients are more prone to APAP toxicity than normal
controls.Treatment will be stopped after two weeks or in the following conditions:
Treatment with APAP will be stopped in healthy volunteers if ALT and/or AST reached three
times the ULN. In patients with NAFLD, treatment will be stopped if: ALT or AST reach ≥ three
times the upper limit of entry value or ≥ 5 times the ULN; or if there is ALT or AST >3 times
ULN and TBili >2xULN or INR >1.5; or if there is ALT or AST >3 times ULN with the appearance
of fatigue, nausea, vomiting, right upper quadrant pain or tenderness, fever, rash, and/or
eosinophilia (>5%). We follow a conservative approach derived from the FDA guidelines for
stopping medications expected to cause drug induced liver injury (DILI). Indeed, the FDA
allows continuation of the medication until ALT or AST are >8x ULN in the absence of elevated
Tbili or INR. Patients who have hepatotoxicity will have close monitoring of their liver
enzymes until they normalize. Taking acetaminophen up to 3g daily has been shown to be safe
and acceptable. We have followed very strict criteria for monitoring and stopping rules
however in the usually cases of toxicity the patient will be admitted for monitoring.