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A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects with Nonalcoholic Steatohepatitis (NASH)

This Phase 3, double-blind, randomized, long-term, placebo-controlled, multicenter international study will evaluate the effect of OCA on histological improvements in NASH, all-cause mortality, and liver-related clinical outcomes. Primary Objective Assessed at 18 Months • To evaluate the effect of OCA compared to placebo on histological improvement in NASH by assessing the following as co-primary endpoints using NASH CRN scoring criteria: − Improvement in fibrosis by at least 1 stage with no worsening of NASH defined as no increase in hepatocellular ballooning or lobular inflammation Page 33 of 261 Protocol 747-303 Version 4: 14 Apr 2016 Page 34 Confidential and Proprietary − Resolution of NASH as defined by overall histopathological interpretation with no worsening of fibrosis 6.2. Secondary Objectives Assessed at 18 Months • To evaluate the effect of OCA compared to placebo on histological improvement in NASH by assessing the following using NASH CRN scoring criteria: − Improvement of fibrosis and NASH as a composite endpoint and as defined by improvement in fibrosis by at least 1 stage and improvement in NAFLD activity score (NAS) by at least 2 points with at least 1 point improvement each for hepatocellular ballooning and lobular inflammation − Resolution of fibrosis − Improvement in NAS by at least 2 points with no worsening of fibrosis − Improvement in each key histological feature of NASH by at least 1 point (steatosis, lobular inflammation, and hepatocellular ballooning)
laurie peiffer at lpeiffer@pennstatehealth.psu.edu or 717-531-5226
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18 year(s) or older
This study is NOT accepting healthy volunteers
NCT02548351
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Inclusion Criteria:
NASH
fibrosis stage 2 or 3
stable body weight
Exclusion Criteria:
cirrhosis
prior cancer
heptocellular cancer
hiv, hcv, hbv
hba1c>9.5
Digestive Systems & Liver Disease
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Location
Hershey, PA