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Clinical Trial Design for Alcoholic Hepatitis.
1Department of Medicine, University of Massachusetts Medical School, Worcester, Massachusetts.
Seminars in Liver Disease
|December 23, 2017
Summary
Alcoholic hepatitis (AH) treatment is limited, but new therapeutic targets are emerging. Clinical trials are needed to develop effective therapies for this severe liver disease.
Area of Science:
- Hepatology
- Gastroenterology
- Internal Medicine
Background:
- Alcoholic hepatitis (AH) is a severe form of alcoholic liver disease with high mortality.
- Current treatment options for AH are limited and often ineffective.
- Understanding AH pathomechanisms reveals potential therapeutic targets.
Purpose of the Study:
- To highlight the need for new therapeutic interventions in alcoholic hepatitis.
- To discuss the potential for repurposing targets from nonalcoholic steatohepatitis research.
- To identify challenges and future directions for clinical trials in AH.
Main Methods:
- Review of recent advances in understanding AH pathomechanisms.
- Analysis of potential therapeutic targets in preclinical and clinical development.
- Discussion of challenges in designing clinical trials for AH.
Main Results:
- Numerous potential therapeutic targets for AH have been identified.
- Many targets are under investigation for nonalcoholic steatohepatitis.
- Challenges in AH clinical trial design include disease severity definition, data elements, and endpoints.
Conclusions:
- The field of AH is poised to develop new targeted therapies.
- Collaboration between regulatory agencies, experts, and industry is crucial.
- Advancing clinical investigations is essential for this underserved patient population.
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