A Retrospective Analysis of Baseline Liver Function Parameters in Subjects with Mild, Moderate or Severe Hepatic Impairment (HI), to Inform the Assessment of Drug-Induced Liver Injury (DILI)

DIA 2020 -- Drug-induced liver injury (DILI) remains a significant concern in early clinical trials. Regulatory guidance documents have addressed monitoring parameters (FDA 2009), however, there remains concern regarding interpretation of these guidelines within special populations, such as those with chronic liver disease (CLD) and baseline impaired hepatic function. It was our goal to assess the baseline liver function parameters of subjects with CLD, and further characterize across mild, moderate and severe hepatic impairment categories (according to Child-Pugh classification). This data may assist with the assessment of DILI in patients with CLD.