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Clinical Trial Details

Title
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
Study Description

This study aims 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 Nonalcoholic Steatohepatitis (NASH).

This study has two parts:

Part 1 is called the Double-Blind phase because neither the participant nor the doctor will know if the participant is receiving the study drug (OCA) or placebo (dummy pill).

Part 2 is called the Open-Label Extension phase because all participants will receive the study drug (OCA), and no one will receive a placebo.

This study is currently closed to enrollment.

Investigators

Principal Investigator
Maged P. Ghali, M.D.
Medicine

Sub Investigator
Neha Agrawal, M.B.B.S. (M.D.)
Medicine