TAK-242 in Patients With Acute Alcoholic Hepatitis

Inclusion Criteria: * History of alcohol-related cirrhosis who continue to drink heavily * History of an acute decompensating event with a clinical and/or liver biopsy diagnosis of alcoholic hepatitis * Grade 1 or 2 ACLF using the CLIF-C OF score; OR bilirubin criteria OR criteria of acute kidney injury Stage 1b or 2 after initial supportive treatment with fluids, albumin, or terlipressin; AND CLIF-C ACLF score is \>35 and \<64 * History of alcohol-related cirrhosis based on clinical, radiological, and/or histological evidence Exclusion Criteria: * Received certain previous therapies (any investigational drug within 30 days of randomization, corticosteroids for alcohol-induced liver failure within 4 weeks of randomization, or received TAK-242 in any previous study) * History of liver cirrhosis from other chronic diseases; liver failure from other causes * History of liver transplantation, post-operative decompensation after partial hepatectomy, acute or subacute liver failure without underlying cirrhosis * Any untreated infections including gram-positive infections, or active or latent atuberculosis, sepsis or septic shock, or coinfection with hepatitis B virus, hepatitis C virus, hepatitis E virus, or HIV * Chronic or pre-existing kidney failure, uncontrolled medical disorder that might confound study results or compromise subject safety, oxygen saturation \<90%, or requires mechanical ventilation. * Uncorrected anemia, methemoglobinemia, disseminated intravascular coagul…