Effect of Alpha-1 Antitrypsin Supplementation on Alcohol-Associated Hepatitis

Inclusion criteria

• ✓. 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).
• ✓. Understands and agrees to comply with the study procedures and provides written informed consent as documented by signature.
• ✓. Outpatient or hospitalized patient not being on the Intensive Care Unit (ICU) at screening.
• ✓. Negative urine pregnancy test, not breastfeeding \& agreement to use highly-effective means of contraception during the study. Allowed are sexual abstinence, vasectomized partners (˃3 months previously-vasectomy has to be confirmed by two negative semen analyses) or the consistent and correct use of an approved contraceptive method in accordance with the product label, for example: Barrier method (such as condoms, diaphragm, or cervical cap) used in conjunction with spermicide; intrauterine device; prescription hormonal contraceptive taken or administered via oral (pill), transdermal (patch), subdermal, or intramuscular (IM) route Inclusion criterion 8 only applies to male patients
• ✓. Male patients who are sexually active with female partners of childbearing potential must agree to use a condom with spermicide and to use one other approved method of highly effective contraception from the time of investigational product administration for at least 90 days after the dose of investigational product and must refrain from sperm donation from Screening through at least 90 days following the last dose of investigational product.

Exclusion criteria