A Placebo-Controlled, Multicenter, Double-Blind, Randomized Trial of IDN-6556 in Patients With Severe Alcoholic Hepatitis and Contraindications to Corticosteroid Therapy


Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

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

Who is eligible to participate?

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

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