DILI in Clinical Trials

Normal Liver NASH
Cholestatic Hepatitis C

Patient has Gilbert's and Tbili is at baseline?
Severe fatigue, nausea, vomiting, right upper quadrant pain.


The last decade has seen a rapid growth in the number of clinical trials enrolling patients with nonalcoholic fatty liver disease and nonalcoholic steatohepatitis (NASH). Due to the underlying chronic liver disease, patients with NASH often require different approaches to the assessment and management of suspected drug‐ induced liver injury (DILI) compared to patients with healthy livers. However, currently no regulatory guidelines or position papers systematically address best practices pertaining to DILI in NASH clinical trials. This calculator provides the consensus recommendations from the paper. (30761572)


See table 1 of the manuscript. Multiple factors play into recommendations.