DUR-928 in Patients With Alcoholic Hepatitis

Exclusion Criteria

• •1. Other or concomitant cause(s) 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. Wilson disease (ceruloplasmin levels \< 10 mcg/L)
• •3. Vascular liver disease
• •4. Drug induced liver disease
• •5. Surface antigen positive hepatitis B (HBsAg+). Note: patients with isolated core antibody (HBcAb) are not excluded.
• •6. Acute hepatitis A
• •7. Acute HCV or chronic hepatitis C with a history of decompensated cirrhosis. Note: patients with stable chronic Hep C Virus (HCV) or successfully treated HCV are not excluded.
• •2. Co-infection with human immunodeficiency virus (HIV)
• •3. Positive Urine Drug Screen (amphetamines, barbiturates, benzodiazepines, cocaine and opiates) except THC and legal prescription medications.
• •4. Any active malignancies other than curatively treated skin cancer (basal cell or squamous cell carcinomas) or any other malignancy diagnosed within the last five years
• •5. Active tuberculosis on chest x-ray at study entry
• •6. Significant systemic or major illness other than liver disease, including coronary artery disease, cerebrovascular disease, pulmonary disease, renal failure, serious psychiatric disease, that, in the opinion of the Investigator would preclude the patient from participating in and completing the study
• •7. Patients requiring the use of vasopressors or inotropic support. Prior use of inotropic support will be allowed if the condition has stabilized within the first 7 days of admission to the hospital
• •8. Liver biopsy, if carried out, showing findings not compatible with AH
• •9. Any patient that has received any investigational drug or device within 30 days of dosing or who is scheduled to receive another investigational drug or device at any time during the study
• •10. Patients who are taking drug products that are primarily the substrates of CYP2C8, such as chloroquine, paclitaxel, rosiglitazone, repaglinide
• •11. If female, known pregnancy, or has a positive serum pregnancy test, or is lactating/breastfeeding
• •12. Serum creatinine \> 2.5 mg/dL
• •13. Patients who have had organ transplantation (such as liver, kidney, lung, heart, bone marrow, or stem cell etc.), other than cornea transplant
• •14. Stage 3 or greater encephalopathy by West Haven criteria