Endpoints and clinical trial design for nonalcoholic steatohepatitis

Arun J. Sanyal, Elizabeth M. Brunt, David E. Kleiner, Kris V. Kowdley, Naga Chalasani, Joel E. Lavine, Vlad Ratziu, Arthur Mccullough

Research output: Contribution to journalArticle

298 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)344-353
Number of pages10
JournalHepatology
Volume54
Issue number1
DOIs
StatePublished - Jul 2011

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Clinical Trials
Point-of-Care Systems
Liver
Non-alcoholic Fatty Liver Disease
Population
Liver Diseases
Fibrosis
Chronic Disease
Cardiovascular Diseases
Biomarkers
Biopsy
Mortality

ASJC Scopus subject areas

  • Hepatology

Cite this

Sanyal, A. J., Brunt, E. M., Kleiner, D. E., Kowdley, K. V., Chalasani, N., Lavine, J. E., ... Mccullough, A. (2011). Endpoints and clinical trial design for nonalcoholic steatohepatitis. Hepatology, 54(1), 344-353. https://doi.org/10.1002/hep.24376

Endpoints and clinical trial design for nonalcoholic steatohepatitis. / Sanyal, Arun J.; Brunt, Elizabeth M.; Kleiner, David E.; Kowdley, Kris V.; Chalasani, Naga; Lavine, Joel E.; Ratziu, Vlad; Mccullough, Arthur.

In: Hepatology, Vol. 54, No. 1, 07.2011, p. 344-353.

Research output: Contribution to journalArticle

Sanyal, AJ, Brunt, EM, Kleiner, DE, Kowdley, KV, Chalasani, N, Lavine, JE, Ratziu, V & Mccullough, A 2011, 'Endpoints and clinical trial design for nonalcoholic steatohepatitis', Hepatology, vol. 54, no. 1, pp. 344-353. https://doi.org/10.1002/hep.24376
Sanyal AJ, Brunt EM, Kleiner DE, Kowdley KV, Chalasani N, Lavine JE et al. Endpoints and clinical trial design for nonalcoholic steatohepatitis. Hepatology. 2011 Jul;54(1):344-353. https://doi.org/10.1002/hep.24376
Sanyal, Arun J. ; Brunt, Elizabeth M. ; Kleiner, David E. ; Kowdley, Kris V. ; Chalasani, Naga ; Lavine, Joel E. ; Ratziu, Vlad ; Mccullough, Arthur. / Endpoints and clinical trial design for nonalcoholic steatohepatitis. In: Hepatology. 2011 ; Vol. 54, No. 1. pp. 344-353.
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