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Alcoholic Hepatitis Treatment Study

Clinical Trial Title: 
Study of an investigational oral drug used in combination with prednisolone to treat patients with alcoholic hepatitis.
Clinical Trial Protocol ID: 
Clinical Trial Investigator Name: 
Nikunj Shah, MD
Clinical Trial Protocol Description: 

The purpose of this study is to test an experimental drug called GS-4997 for the treatment of severe alcoholic hepatitis (AH). Currently, the standard of care for treatment of AH is prednisolone, a corticosteroid. In this study, GS-4997 or placebo will be tested in combination with prednisolone. Nationwide, 120 subjects will be recruited for this study. At Rush University Medical Center, we expect to recruit 5 subjects. The treament will be assigned randomly.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Have a clinical diagnosis of severe alcoholic hepatitis.
  • Be willing to use a highly effective method of birth control if you are a female of child bearing potential.

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

  • Have other causes of liver disease.
  • Have a MELD score of > 30.
  • Have a history of hepatocellular carcinoma or prior liver transplant.

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 Giczewski, RN