๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
1. Male or female patient โฅ18 years of age at time of consent.
2. Severe AAH (Maddrey's discriminant function score โฅ 32) at screening.
3. No ACLF or ACLF Grade 1 at screening.
4. Daily average intake of \>80 g (men)/\>60 g (women) ethanol during the past 3 months (patient reported).
5. Understands and agrees to comply with the study procedures and provides written informed consent as documented by signature.
6. Outpatient or hospitalized patient not being on the Intensive Care Unit (ICU) at screening.
Inclusion criterion 7 only applies to women of childbearing potential (WOCBP)
7. Negative urine pregnancy test, not breastfeeding \& agreement to use highly-effective means of contraception during the study. Allowed are sexual abstinence, vasectomized partners (ห3 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
8. 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.
9. Ability to speak and read German to a level which allows fully comprehending the meaning of everything that is said and written.
Exclusion Criteria:
1. Uncontrolled Diabetes Mellitus type 1 or 2 (defined by HbA1c \> 10%).
2. Corticosteroid use contraindicated.
3. Viral hepatitis, autoimmune hepatitis, HIV infection, Wilson disease, hemochromatosis, toxic liver injury, Primary Biliary Cholangitis (PBC), Primary Sclerosing Cholangitis (PSC).
4. Participation in another interventional clinical study within 6 months prior to screening and/or during trial participation.
5. Presence of any active malignancy (other than non-melanoma skin cancer) which required treatment within the past 12 months.
6. Chronic kidney disease receiving dialysis.
7. Do Not Attempt Resuscitation (DNAR) order in place.
8. IgA deficiency (IgA level \<7mg/dL) or known intolerance to A1AT.
9. History of liver transplantation or currently listed for liver transplant.
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