Alpha-1 Antitrypsin to help inflammation in severe alcohol-related hepatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2, open-label pilot trial conducted at a single center. Participants with severe alcohol-associated hepatitis will receive Alpha-1 Antitrypsin to see if it lowers systemic inflammation and affects clinical outcomes. Safety and adverse events will be tracked alongside changes in inflammatory cytokines. The study aims to provide preliminary data on whether A1AT is beneficial in this patient population. Results could guide larger future studies if signals of benefit emerge.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male or female patient ≥18 years of age at time of consent.
2. Severe AAH (Maddrey's discriminant function score ≥ 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 (˃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
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.

Where it's running

• Medical University Innsbruck
  Innsbruck, Austria Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Integrated alcohol‑use and liver treatments for severe alcohol‑associated hepatitis

  This trial tests whether adding medication (acamprosate) plus counseling for alcohol use disorder to liver therapy helps people with severe alcohol‑associated hepatitis drink less and have better liver outcomes at six months, and also compares a new drug (F‑652) to prednisone for short‑term survival.

  Recruiting at 6 sites Phase 2 Indiana University · Indianapolis, Indiana and 5 other locations · NCT07060638

• Safety of sedation with non-anesthesiologist-administered propofol during interventional endoscopy

  This study tests how safe and effective the use of propofol given by non-anesthesiologists is during interventional gastrointestinal endoscopy for adults.

  Recruiting Medical University Innsbruck · Innsbruck, Tyrol · NCT07872657

• Understanding how social thinking, brain signals, and iron biology change with age in schizophrenia

  This study tests whether social cognition and brain biology change over time in people with schizophrenia compared to healthy adults.

  Recruiting Medical University Innsbruck · Innsbruck, Tyrol · NCT07856381

• Obinutuzumab vs steroids for adults with minimal change disease

  This study tests whether obinutuzumab can induce remission in adults with minimal change disease and whether it reduces relapses compared with glucocorticoids.

  Recruiting at 2 sites Phase 2 Medical University Innsbruck · Graz and 5 other locations · NCT07710157

• Cardiovascular Rehabilitation After Abdominal Aortic Aneurysm Repair

  This study tests whether a structured cardiovascular rehabilitation program after abdominal aortic aneurysm repair leads to better fitness and quality of life than standard postoperative care.

  Recruiting Medical University Innsbruck · Innsbruck, Tyrol · NCT07690046

• Digital Atrial Fibrillation Screening to Prevent Stroke in Older Adults

  Older adults in Austria will try a smartphone-based atrial fibrillation screening app to see if it reduces stroke hospitalizations compared with usual care.

  Recruiting Medical University Innsbruck · Innsbruck, Tyrol · NCT07684053

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.