Efficacy and Safety of Orally Administered DS102 in Patients With Acute Alcoholic Hepatitis

Exclusion Criteria

• •1. Pregnant or lactating females.
• •2. Spontaneous liver function improvement defined by decrease of bilirubin level and MDF of \>10% within 5 days of hospital admission
• •3. Grade 4 hepatic encephalopathy (West Haven Criteria)
• •4. Type 1 hepatorenal syndrome (HRS) or a serum creatinine \>2 x ULN or the requirement for haemodialysis
• •5. History of hypersensitivity to any substance in DS102 capsules or placebo capsules.
• •6. Alcohol abstinence of \>6 weeks prior to screening
• •7. Duration of clinically apparent jaundice \>3 months prior to baseline
• •8. Other causes of liver disease including:
• •1. Evidence of chronic viral hepatitis (Hepatitis B DNA positive or HCV RNA positive)
• •2. Biliary obstruction
• •3. Hepatocellular carcinoma
• •4. Wilsons disease
• •5. Budd Chiari Syndrome
• •6. Non-alcoholic fatty liver disease
• •9. History of or active non-liver malignancies other than curatively treated skin cancer (basal cell or squamous cell carcinomas).
• •10. Previous entry into the study
• •11. AST \>400 U/L or ALT \>270 U/L
• •12. Treatment with any experimental drug within 30 days prior to Day 0 visit (Baseline), or 5 half-lives (whichever is longer).
• •13. Patients who have used dietary supplements rich in omega-3 or omega-6 fatty acids in the four weeks prior to baseline.
• •14. Patients dependent on inotropic support (adrenaline or noradrenaline), including Terlipressin
• •15. Active variceal haemorrhage on this admission requiring more than 2 units of blood to maintain haemoglobin level within 48 hours
• •16. Presence of refractory ascites
• •17. Untreated or unresolved sepsis
• •18. Patients with cerebral haemorrhage, extensive retinal haemorrhage, acute myocardial infarction (within last 6 weeks) or severe cardiac arrhythmias (not including atrial fibrillation)
• •19. Known infection with HIV at screening.
• •20. Significant systemic or major illnesses other than liver disease that, in the opinion of the investigator, would preclude or interfere with treatment with DS102 and/or adequate follow up.
• •21. Previous liver transplantation