The trial is designed as a prospective, single center, open label, randomized controlled pilot study evaluating the effect of A1AT (Alpha 1 Antitrypsin) on inflammation in patients with severe AAH (alcohol-associated hepatitis).
The objective is to evaluate the safety and the effect of intravenous A1AT on the systemic inflammation in patients with severe AAH. The objectives also include the assessment of A1AT on clinical outcomes including the incidence of adverse events (AEs) and serious adverse events (SAEs) and the cytokine.
Male or female patient ≥18 years of age at time of consent.
Severe AAH (Maddrey's discriminant function score ≥ 32) at screening.
No ACLF or ACLF Grade 1 at screening.
Daily average intake of >80 g (men)/>60 g (women) ethanol during the past 3 months (patient reported).
Uncontrolled Diabetes Mellitus type 1 or 2 (defined by HbA1c > 10%).
Corticosteroid use contraindicated.
Viral hepatitis, autoimmune hepatitis, HIV infection, Wilson disease, hemochromatosis, toxic liver injury, Primary Biliary Cholangitis (PBC), Primary Sclerosing Cholangitis (PSC).
Participation in another interventional clinical study within 6 months prior to screening and/or during trial participation.