Article
Case definitions for inclusion and analysis of endpoints in clinical trials for nonalcoholic steatohepatitis through the lens of regulatory science.
Hepatology (Baltimore, Md.) - 1 May 2018
Siddiqui Mohammad Shadab, Harrison Stephen A, Abdelmalek Manal F, Anstee Quentin M, Bedossa Pierre, Castera Laurent, Dimick-Santos Lara, Friedman Scott L, Greene Katherine, Kleiner David E, Megnien Sophie, Neuschwander-Tetri Brent A, Ratziu Vlad, Schabel Elmer, Miller Veronica, Sanyal Arun J
Abstract excerpt
Nonalcoholic steatohepatitis (NASH) is an important cause of liver-related morbidity and mortality. There are no approved therapies, and the results of clinical trials have been difficult to compare due to inconsistent definitions of relevant disease parameters in patients with NASH. The natural course of the disease has not been rigorously characterized, particularly with respect to the contributions of...
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