Status:
NOT_YET_RECRUITING
Effect of Alpha-1 Antitrypsin Supplementation on Alcohol-Associated Hepatitis
Lead Sponsor:
Medical University Innsbruck
Conditions:
Alcohol-Associated Hepatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 (al...
Detailed Description
About 5-7 % of patients with alcohol-associated chronic liver disease transform into acute on chronic liver disease (ACLF) per year. In patients with underlying alcohol-associated liver disease (ALD) ...
Eligibility Criteria
Inclusion
- 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.
- Inclusion criterion 7 only applies to women of childbearing potential (WOCBP)
- 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.
- Ability to speak and read German to a level which allows fully comprehending the meaning of everything that is said and written.
Exclusion
- 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.
- Presence of any active malignancy (other than non-melanoma skin cancer) which required treatment within the past 12 months.
- Chronic kidney disease receiving dialysis.
- Do Not Attempt Resuscitation (DNAR) order in place.
- IgA deficiency (IgA level \<7mg/dL) or known intolerance to A1AT.
- History of liver transplantation or currently listed for liver transplant.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06582329
Start Date
April 1 2025
End Date
December 1 2026
Last Update
March 6 2025
Active Locations (1)
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1
Medical University Innsbruck
Innsbruck, Austria