A-TANGO Phase 2 Study

Who can take part

• Patients accepted for inclusion into the study must meet all of the following criteria:; Male and female subjects ≥18 of age and ≤75 years of age; Compliance with acceptable contraceptive methods; With a diagnosis of severe alcoholic hepatitis that is resistant to steroid therapy as defined by a Lille score of >0.45 and/or in whom steroids are contraindicated; Eligible subjects will have Grade 1-3 ACLF with a maximum of three organ failures using the CLIF-C OF score AND the CLIF-C ACLF-CRP score of >35 and <60

Who cannot take part

• Patients with any of the following criteria are to be excluded:; Refusal to give informed consent; Mechanical ventilation due to respiratory failure and/or need for renal replacement therapy and or requiring inotropes for circulatory support with a noradrenaline requirement of >0.5ug/kg/min to maintain mean arterial pressure > 70mmHg; Subject has received any investigational drug within 30 days of randomization; Subject has any of the following conditions:; history of liver transplantation; postoperative decompensation after partial hepatectomy; liver failure without underlying chronic liver injury; Any untreated infections (<48h antibiotic therapy) including gram-positive infections, active tuberculosis or coinfection with HIV; Chronic or pre-existing kidney failure, survival prognosis of <6 months due to severe co-morbid conditions that might confound study results or compromise subject safety; Methemoglobinemia, clinically-significant disseminated intravascular coagulation, uncontrolled bleeding, sickle cell anemia; Uncontrolled seizures, Creutzfeldt-Jakob disease, glucose-6-phosphate dehydrogenase deficiency; Active malignancy, premalignant hematological disorders (e.g., myelodysplastic syndrome, chronic myeloid leukemia) or multiorgan failure (≥ 4 organ failures); Pregnancy or nursing women; Allergy to eggs