A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy And Safety Of Obeticholic Acid In Subjects With Compensated Cirrhosis Due To Nonalcoholic Steatohepatitis
Principal Investigator(s)
Email for information
Funded by
GENEVA
Research Start Date
Status
Active
This Phase 3, double-blind, randomized, placebo-controlled, multicenter international study will evaluate the efficacy and safety of OCA in subjects with a biopsy-confirmed diagnosis of cirrhosis (based on a fibrosis score of 4 using the NASH CRN scoring system) due to NASH (determined by central reading of liver histology). Up to approximately 30% of total enrolled subjects may have a diagnosis of cryptogenic cirrhosis and presence of metabolic risk factors. Subjects with hepatic decompensation or CP Class B or Class C cirrhosis are excluded. Subjects who progress to CP Class B or Class C during the study will discontinue investigational product, but should be encouraged to continue study visits.
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