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

Overview

About this study

The main purpose of the study is to test if taking a study drug called emricasan (also known as IDN-6556 and PF-03491390) will affect overall patient survival after one month of treatment.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Please contact the study team to discuss whether or not you are eligible to participate in a study.

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Vijay Shah, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20113400

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