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Treatment Study for Patients with Compensated Cirrhosis Caused by Non-Alcoholic Steatohepatitis

Clinical Trial Title: 
This is a study of an investigational drug used to treat patients with compensated cirrhosis caused by non-alcoholic steatohepatitis (NASH).
Clinical Trial Protocol ID: 
18010402
Clinical Trial Investigator Name: 
Sujit Janardhan, MD
Clinical Trial Protocol Description: 

The purpose of this study is to find out how safe and effective the investigational drug, obeticholic (also known as OCA), may be in improving compensated cirrhosis caused by NASH when compared with placebo. 540 total patients will be recruited for this study. At Rush University Medical Center, we expect to recruit 3 subjects. The treatment will be assigned randomly.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Have biopsy confirmed NASH and stage 4 fibrosis (cirrhosis).

You will be excluded from the study if any of the following criteria apply to you:

  • Have a history of ascites, spntaneous bacterial paritonitis, variceal bleeding, hepatic encephalopathy or hepatorenal/hepatopulmonary syndromes.
  • Have a MELD score > 20.
  • Have a history of non-bleeding varices within the past 6 months.

This is a partial list of inclusion and exclusion criteria.

Clinical Trial Area: 
Liver, Biliary and Pancreatic Disorders
Contact Phone: 
(312) 563-3919
Contact Name: 
Diana Goldman, RN, CCRC