Study of IDN-6556 in Patients With Severe AH and Contradictions to Steroid Therapy

The study will also see if overall patient survival is affected at 6 months, and if the
study drug improves liver functioning.

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+), and

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