Case definitions for inclusion and analysis of endpoints in clinical trials for nonalcoholic steatohepatitis through the lens of regulatory science-Reference-Cited by-同舟云学术

Case definitions for inclusion and analysis of endpoints in clinical trials for nonalcoholic steatohepatitis through the lens of regulatory science

Published:2018-02-22 Issue:5 Volume:67 Page:2001-2012
ISSN:0270-9139
Container-title:Hepatology
language:en
Short-container-title:Hepatology

Author:

Siddiqui Mohammad Shadab¹,Harrison Stephen A.²,Abdelmalek Manal F.³,Anstee Quentin M.⁴,Bedossa Pierre⁵,Castera Laurent⁶,Dimick-Santos Lara⁷,Friedman Scott L.⁸,Greene Katherine⁹,Kleiner David E.¹⁰,Megnien Sophie¹¹,Neuschwander-Tetri Brent A.¹²,Ratziu Vlad¹³,Schabel Elmer¹⁴,Miller Veronica⁹,Sanyal Arun J.¹,

Affiliation:

1. Virginia Commonwealth University; Richmond VA

2. Pinnacle Clinical Research; San Antonio TX

3. Division of Gastroenterology & Hepatology; Duke University School of Medicine; Durham NC

4. Institute of Cellular Medicine; Newcastle University; Newcastle Upon Tyne United Kingdom

5. Department of Pathology, Physiology and Imaging; University of Paris Diderot; Clichy France

6. Department of Hepatology, Hôpital Beaujon; Clichy France

7. Center for Drug Evaluation and Research, US Food and Drug Administration; Silver Springs MD

8. Division of Liver Disease, Icahn School of Medicine at Mount Sinai; New York NY

9. Forum for Collaborative Research; University of California Berkeley; Washington DC

10. National Cancer Institute, Center for Cancer Research; Bethesda MD

11. Genfit Corp; Cambridge MA

12. Division of Gastroenterology and Hepatology; Saint Louis University School of Medicine; St. Louis MO

13. Department of Hepatology and Gastroenterology; Hôpital Pitié Salpêtrière et Université Pierre et Marie Curie; Paris France

14. Gastroenterology & Hepatology Unit, Bundesinstitut für Arzneimittel und Medizinprodukte; Bonn Germany

Funder

National Institutes of Health

Intramural Research Program of the National Institutes of Health, National Cancer Institute

Publisher

Wiley

Subject

Hepatology

Reference55 articles.

1. Prevalence of hepatic steatosis in an urban population in the United States: impact of ethnicity;Browning;Hepatology,2004

2. The histological course of nonalcoholic fatty liver disease: a longitudinal study of 103 patients with sequential liver biopsies;Adams;J Hepatol,2005

3. Fibrosis progression in nonalcoholic fatty liver vs nonalcoholic steatohepatitis: a systematic review and meta-analysis of paired-biopsy studies;Singh;Clin Gastroenterol Hepatol,2015

4. Nonalcoholic steatohepatitis is the second leading etiology of liver disease among adults awaiting liver transplantation in the United States;Wong;Gastroenterology,2015

5. Challenges and opportunities in drug and biomarker development for nonalcoholic steatohepatitis: findings and recommendations from an American Association for the Study of Liver Diseases-U.S. Food and Drug Administration joint workshop;Sanyal;Hepatology,2015

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