Protocol Information

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Title 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). 747-303
Description Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment

The study visits will be in downtown Buffalo.
Objective "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. Approximately 1875 subjects with biopsy-confirmed, precirrhotic NASH and evidence of liver fibrosis will be enrolled in the study, including approximately 60% with fibrosis stage 3 and no more than 40% with fibrosis stage 2. An additional cohort of 190 subjects with fibrosis stage 1 and at least
1 accompanying comorbidity will also be enrolled for exploratory purposes, for a total of approximately 2065 subjects."

Keywords: NASH, liver fibrosis, Non-alcoholic Steatohepatitis
Principal Investigator TALAL, ANDREW
Age Group Adult
Drugs Involved Obeticholic Acid
Status Open
Key Eligibility Nonalcoholic Steatohepatitis (NASH)
Liver fibrosis stage 1, 2 or 3
No presence of liver cirrhosis
Disease Group Digestive System; Liver Diseases
Treatment Obeticholic Acid