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Case definitions for inclusion and analysis of endpoints in clinical trials for nonalcoholic steatohepatitis through the lens of regulatory science.
Hepatology. 2018 May;67(5):2001-2012. doi: 10.1002/hep.29607. Epub 2018 Feb 22.
Hepatology. 2018.
PMID: 29059456
Free PMC article.
Elafibranor, an Agonist of the Peroxisome Proliferator-Activated Receptor-α and -δ, Induces Resolution of Nonalcoholic Steatohepatitis Without Fibrosis Worsening.
Ratziu V, Harrison SA, Francque S, Bedossa P, Lehert P, Serfaty L, Romero-Gomez M, Boursier J, Abdelmalek M, Caldwell S, Drenth J, Anstee QM, Hum D, Hanf R, Roudot A, Megnien S, Staels B, Sanyal A; GOLDEN-505 Investigator Study Group.
Ratziu V, et al. Among authors: megnien s.
Gastroenterology. 2016 May;150(5):1147-1159.e5. doi: 10.1053/j.gastro.2016.01.038. Epub 2016 Feb 11.
Gastroenterology. 2016.
PMID: 26874076
Free article.
Clinical Trial.
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A blood-based biomarker panel (NIS4) for non-invasive diagnosis of non-alcoholic steatohepatitis and liver fibrosis: a prospective derivation and global validation study.
Harrison SA, Ratziu V, Boursier J, Francque S, Bedossa P, Majd Z, Cordonnier G, Sudrik FB, Darteil R, Liebe R, Magnanensi J, Hajji Y, Brozek J, Roudot A, Staels B, Hum DW, Megnien SJ, Hosmane S, Dam N, Chaumat P, Hanf R, Anstee QM, Sanyal AJ.
Harrison SA, et al. Among authors: megnien sj.
Lancet Gastroenterol Hepatol. 2020 Nov;5(11):970-985. doi: 10.1016/S2468-1253(20)30252-1. Epub 2020 Aug 5.
Lancet Gastroenterol Hepatol. 2020.
PMID: 32763196
Clinical Trial.
Item in Clipboard
Factors to Consider in Development of Drugs for Pediatric Nonalcoholic Fatty Liver Disease.
Vos MB, Dimick-Santos L, Mehta R, Omokaro SO, Taminiau J, Schabel E, Kleiner DE, Szitanyi P, Socha P, Schwimmer JB, Noviello S, Silberg DG, Torstenson R, Miller V, Lavine JE; Liver Forum Pediatric Working Group.
Vos MB, et al.
Gastroenterology. 2019 Dec;157(6):1448-1456.e1. doi: 10.1053/j.gastro.2019.08.048. Epub 2019 Sep 12.
Gastroenterology. 2019.
PMID: 31520612
Free PMC article.
No abstract available.
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A randomized placebo-controlled trial of elafibranor in patients with primary biliary cholangitis and incomplete response to UDCA.
Schattenberg JM, Pares A, Kowdley KV, Heneghan MA, Caldwell S, Pratt D, Bonder A, Hirschfield GM, Levy C, Vierling J, Jones D, Tailleux A, Staels B, Megnien S, Hanf R, Magrez D, Birman P, Luketic V.
Schattenberg JM, et al. Among authors: megnien s.
J Hepatol. 2021 Jun;74(6):1344-1354. doi: 10.1016/j.jhep.2021.01.013. Epub 2021 Jan 21.
J Hepatol. 2021.
PMID: 33484775
Free article.
Clinical Trial.
Item in Clipboard
Gastrointestinal tolerance to an inulin-rich soluble roasted chicory extract after consumption in healthy subjects.
Ripoll C, Flourié B, Megnien S, Hermand O, Janssens M.
Ripoll C, et al. Among authors: megnien s.
Nutrition. 2010 Jul-Aug;26(7-8):799-803. doi: 10.1016/j.nut.2009.07.013.
Nutrition. 2010.
PMID: 19931416
Clinical Trial.
Item in Clipboard
Baseline Parameters in Clinical Trials for Nonalcoholic Steatohepatitis: Recommendations From the Liver Forum.
Patel YA, Imperial JC, Muir AJ, Anstee QM, DeBrota D, Dimick-Santos L, Filozof C, Mehta R, Sanyal AJ, Schabel E, Neuschwander-Tetri BA, Miller V; Liver Forum’s Data Standardization Working Group.
Patel YA, et al.
Gastroenterology. 2017 Sep;153(3):621-625.e7. doi: 10.1053/j.gastro.2017.07.024. Epub 2017 Jul 27.
Gastroenterology. 2017.
PMID: 28757264
Free PMC article.
No abstract available.
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