Clinical Trials

Inclusion Criteria:

• Male or female patients 21 years of age or older
• Patients with alcoholic hepatitis defined as:
  1. History of heavy alcohol abuse use: >40 g/day in females and >60 g/day in males for a minimum period of 6 months
  2. Consumed alcohol within 6 weeks of entry into the study
  3. Biochemical parameters of severe disease as evidenced by MELD score >20 but <35, or MELD score 35-40 if the SOFA score is <10

• Patients with established contraindications to steroid use including but not limited to the following:
  1. GI bleed
  2. Active infection, including spontaneous bacterial peritonitis, based on positive blood culture, urine culture, or chest x-ray (if positive, must have been on antibiotics for at least 24 hours prior to study entry)
  3. Acute pancreatitis (increased lipase > 3x ULN or radiologic evidence)
  4. Positivity for hepatitis B (HBsAg+) or C virus (HCV+)
  5. Renal failure

Exclusion Criteria:

• Other or concomitant cause of liver disease as a result of:
  1. Autoimmune liver disease (positive anti-mitochondrial antibody and smooth muscle antibody, positive reading on anti-nuclear antibody titer >1:160)
  2. Metabolic liver disease (abnormal ceruloplasmin levels)
  3. Vascular liver disease
  4. Drug induced liver disease
• Sepsis as evidenced by positive blood or urine culture, pneumonia as confirmed by x-ray
• History of renal transplant and/or on dialysis at time of entry into study
• Diagnosed or suspected systemic lupus erythematosus (SLE) and/or rheumatoid arthritis (RA)
• Hepatocellular carcinoma (HCC) at entry into the study
• Active non-liver malignancies other than curatively treated skin cancer (basal cell or squamous cell carcinomas)
• Liver biopsy, if carried out, showing findings not compatible with alcoholic hepatitis