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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

this study is looking for patients with compensated cirrhosis as the result of non-alcoholic steatohepatitis (NASH). ]). NASH is the result of too much fat within the liver, resulting in injury and death to individual liver cells; the presence of injury like this is followed by progressive formation (laying down) of liver fibrosis (scar tissue); the result of this is increased liver stiffness. As more and more fibrosis is formed and laid down in the liver, the outcome is cirrhosis. Compensated cirrhosis means the liver has become very scarred but can still perform many important bodily functions. This research is being done to find out how safe and effective the investigational drug (also called a study drug) obeticholic acid (also known as OCA) may be in improving compensated cirrhosis caused by NASH (non-alcoholic steatohepatitis). Currently, there are no therapies approved for the treatment of NASH. OCA (the brand name is Ocaliva) has been approved in several regions in North Americacountries (including the United States,and Canada) and Europe) for the treatment of another form of chronic liver disease called Primary Biliary Cholangitis (PBC).
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
NCT03439254
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Inclusion Criteria:
NASH with cirrhosis
willing to use contraception
Exclusion Criteria:
hepatic decompensation
history of liver transplant
significant cardiovascular disease
alcohol abuse
Digestive Systems & Liver Disease
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Location
Hershey, PA