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Study on the Effects of Alpha-1 Antitrypsin and Prednisolone in Patients with Severe Alcohol-Related Hepatitis

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for Alcohol-Associated Hepatitis, a liver condition caused by excessive alcohol consumption. The study will use a medication called Alpha-1 Antitrypsin, which is a protein that helps reduce inflammation in the body. The treatment involves administering this protein through an intravenous infusion, which means it is given directly into the bloodstream through a vein.

The purpose of the study is to evaluate how effective Alpha-1 Antitrypsin is in reducing inflammation in patients with severe forms of this liver condition. Participants in the study will receive the treatment once a week for four weeks. Some participants will receive a placebo instead of the active treatment. The study will monitor the effects of the treatment over a period of time to see if it helps improve the condition of the liver and overall health of the participants.

Throughout the study, participants will have regular check-ups to assess their health and any changes in their condition. The study aims to gather information on the safety and effectiveness of Alpha-1 Antitrypsin as a potential treatment for Alcohol-Associated Hepatitis. This research could provide valuable insights into new ways to manage and treat this liver disease.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will be informed about the procedures and will provide written consent to participate.
The patient must meet specific criteria, such as being 18 years or older, having severe alcohol-associated hepatitis, and not being in intensive care.
Step 2
Baseline visit
The baseline visit occurs on Day 1. During this visit, initial assessments are conducted, including blood tests to measure certain markers in the blood.
The patient will begin receiving the standard treatment for their condition.
Step 3
Medication administration
The patient will receive an intravenous infusion of human alpha1-proteinase inhibitor at a dose of 120 mg per kilogram of body weight once a week for four weeks.
This medication is administered in addition to the standard treatment.
Step 4
Follow-up visits
Follow-up visits are scheduled to monitor the patient's response to the treatment. The first follow-up visit is on Day 8, where blood tests will be repeated.
Additional follow-up visits occur on Day 29 and continue until the end of the study period, which is approximately 90 days from the start.
Step 5
End of study visit
The final visit occurs around Day 90. During this visit, the patient's overall health and response to the treatment are evaluated.
The study aims to assess the effect of the treatment on inflammation and other health markers.

Who can join the trial?

9 criteria

Must be a male or female who is at least 18 years old.
Must have severe **Alcohol-Associated Hepatitis (AAH)**, which is a liver condition caused by drinking too much alcohol. This is determined by a specific score called **Maddrey's discriminant function score**, which should be 32 or higher.
Must not have **ACLF** (Acute-on-Chronic Liver Failure) or only have **ACLF Grade 1** at the time of screening.
Must have consumed an average of more than 80 grams of alcohol per day for men, or more than 60 grams per day for women, over the past 3 months. This is based on what the patient reports.
Must understand and agree to follow the study procedures and provide written consent by signing a form.
Must be an outpatient or a hospitalized patient who is not in the Intensive Care Unit (ICU) at the time of screening.
For women who can have children, they must have a negative urine pregnancy test, not be breastfeeding, and agree to use highly effective birth control methods during the study. This can include not having sex, having a partner who had a vasectomy, or using approved birth control methods like condoms with spermicide, an intrauterine device, or prescription hormonal contraceptives.
For men who are sexually active with women who can have children, they must agree to use a condom with spermicide and another approved birth control method from the time they start the study treatment and for at least 90 days after the last dose. They must also not donate sperm during this time.
Must be able to speak and read German well enough to fully understand everything that is said and written in the study.

Who cannot join the trial?

7 criteria

Patients who are pregnant or breastfeeding cannot participate.
Individuals with a history of severe allergic reactions to the study medication are excluded.
Patients with other serious health conditions that might interfere with the study are not eligible.
People who are currently participating in another clinical trial are not allowed to join.
Individuals with a history of drug or alcohol abuse that could affect the study results are excluded.
Patients who have received certain medications that might interfere with the study treatment are not eligible.
Anyone who cannot comply with the study procedures or follow-up visits is excluded.

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Verified sites

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Medizinische Universitaet Innsbruck
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Innsbruck, Austria

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Investigated drugs

Alpha-1 Antitrypsin (A1AT) is a protein that helps protect the lungs and liver from damage. In this clinical trial, it is being used to see if it can reduce inflammation in patients with severe alcohol-associated hepatitis. The medication is given through an intravenous infusion, which means it is delivered directly into the bloodstream. The goal is to see if this treatment can help improve the condition of patients by reducing the harmful effects of inflammation on the liver.

What is already known about the treatment

Alpha-1 Antitrypsin – This medication is administered intravenously, typically at a dose of 120 mg per kg of body weight once a week for four weeks. It is currently being studied in clinical trials for its potential benefits in treating alcohol-associated hepatitis. The main therapeutic indication is to reduce inflammation in patients with severe forms of this liver condition. At the molecular level, Alpha-1 Antitrypsin works by inhibiting enzymes that cause tissue damage, thereby reducing inflammation. It is classified as a protease inhibitor in pharmacology.

Investigated diseases

Alcohol-Associated Hepatitis – This disease is a liver condition caused by excessive alcohol consumption, leading to inflammation of the liver. It often occurs after years of heavy drinking, but can also develop after a short period of excessive alcohol intake. The inflammation can cause symptoms such as jaundice, abdominal pain, and nausea. As the condition progresses, it may lead to liver scarring and impaired liver function. The severity of symptoms can vary, with some individuals experiencing mild discomfort while others may have severe liver damage. The progression of the disease depends on continued alcohol use and the body's response to liver inflammation.