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Semin Liver Dis 2017; 37(04): 332-342
DOI: 10.1055/s-0037-1608788
Review Article
Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Clinical Trial Design for Alcoholic Hepatitis

Gyongyi Szabo
1   Department of Medicine, University of Massachusetts Medical School, Worcester, Massachusetts
› Author Affiliations
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Publication History

Publication Date:
22 December 2017 (online)

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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
 

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