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Effect of Alpha-1 Antitrypsin Supplementation in Alcohol-Associated Hepatitis-A prospective Pilot Study
EU CTIS ID: 2024-515794-99-00
What this study is testing
Primary objective is to evaluate the effect of intravenous A1AT (of 120mg/kg of body weight once a week for 4 weeks) on inflammation in patients with severe AAH.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 1. Uncontrolled Diabetes Mellitus type 1 or 2 (as 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 study 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.
See the full eligibility 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.
- 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 cercival cap) used in conjunction with spermicide; intrauterine device; prescription hormonal contraceptive taken or administered via oral (pill), transdermal (patch), subdermal, or IM route. Inclusion criterion 7 only applies to women of childbearing potential (WOCBP)
- 8. Male patients who are sexually active with female partners of childbearing potential must agree to use a condom. Inclusion criterion 8 only applies to male patientswith 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.
- 1. Uncontrolled Diabetes Mellitus type 1 or 2 (as 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 study 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.