Trial of Obeticholic Acid in Patients With Moderately Severe Alcoholic Hepatitis (AH)

Inclusion Criteria

• •Individuals ≥ 21 years with a diagnosis of acute AH. The diagnosis of acute alcoholic hepatitis will be based on clinical features and testing including hepatomegaly, jaundice, fever, leukocytosis, compatible liver biochemistries in the context of heavy alcohol consumption. A liver biopsy is not mandatory, but will be required to confirm the diagnosis if a firm diagnosis of AH cannot be made on clinical and laboratory criteria
• •Moderate severity defined as MELD score \> 11 and \< 20
• •Heavy alcohol consumption (defined as \> 40 grams per day on average in women and \> 60 grams per day on average in men for a minimum of 6 months and within the 6 weeks prior to study enrollment)
• •Written informed consent
• •Negative urine pregnancy test where appropriate
• •Women of child bearing potential should be willing to practice contraception throughout the treatment period