Article first published online: 24 JUN 2011
Copyright © 2011 American Association for the Study of Liver Diseases
Volume 54, Issue 1, pages 344–353, July 2011
How to Cite
Sanyal, A. J., Brunt, E. M., Kleiner, D. E., Kowdley, K. V., Chalasani, N., Lavine, J. E., Ratziu, V. and McCullough, A. (2011), Endpoints and clinical trial design for nonalcoholic steatohepatitis. Hepatology, 54: 344–353. doi: 10.1002/hep.24376
Potential conflict of interest: Dr. Chalasani declares that he has served as a consultant in the NAFLD/NASH area for the following entities over the last 24 months: Amylin, Gilead, Genentech, and Fulcrum/Mochida. He has served as a consultant in the drug hepatotoxicity area for the following entities over the last 24 months: Abbott, J&J, KaroBio, Teva, Salix, and Merck. He has received research funding from Eli Lilly and Amylin. Dr. Kowdley has received funds for a clinical trial of NASH from Mochida Pharmaceuticals. The other authors have nothing to report.
This work was supported by the American Association for the Study of Liver Diseases and represents the summary of the 2009 workshop on “Endpoints in Nonalcoholic Steatohepatitis” along with updated information where applicable. This work was also supported, in part, by the Intramural Research Program of the National Institutes of Health, National Cancer Institute.
- Issue published online: 24 JUN 2011
- Article first published online: 24 JUN 2011
- Accepted manuscript online: 21 APR 2011 07:50AM EST
- Manuscript Accepted: 8 APR 2011
- Manuscript Received: 28 JAN 2011
Nonalcoholic fatty liver disease is a common cause of chronic liver disease in the general population. Nonalcoholic steatohepatitis (NASH), the aggressive form of nonalcoholic fatty liver disease, is associated with an increased risk of liver-related mortality and cardiovascular disease. At present, a liver biopsy is the only generally acceptable method for the diagnosis of NASH and assessment of its progression toward cirrhosis. Although several treatments have shown evidence of efficacy in clinical trials of varying design, there are no approved treatments for NASH, and published trials are often too divergent to allow meaningful comparisons. There is thus a lack of established noninvasive, point-of-care diagnostics and approved treatment on one hand and a substantial population burden of disease on the other. These provide the rationale for developing consensus on key endpoints and clinical trial design for NASH. Conclusion: This article summarizes the consensus arrived at a meeting of the American Association for the Study of Liver Diseases on the key endpoints and specific trial design issues that are germane for development of diagnostic biomarkers and treatment trials for NASH. (HEPATOLOGY 2011;)