Abstract
Alcoholic hepatitis (AH) is an acute and clinically distinct manifestation of alcoholic
liver disease. While severe AH causes 30% or higher mortality in 3 months, treatment
options are limited and ineffective. Recent advances on the understanding of the pathomechanisms
of AH have identified numerous potential targets for new therapeutic interventions.
Many of those targets are currently under preclinical testing and/or in human clinical
trials for nonalcoholic steatohepatitis. Thus, the field of AH should be ready to
launch new efforts and targeted clinical trials for this underserved patient population.
There are remaining challenges in designing clinical trials in AH that include definition
of the severity of disease, common data elements in clinical trial design, and selection
of clinically meaningful endpoints. Future efforts and consensus meetings between
regulatory agencies, academic and clinical experts, and industry will be instrumental
to advance this emerging and greatly needed field of clinical investigations.
Keywords
alcoholic liver disease - endpoints - common data elements
