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Study on the Effectiveness of N-Acetylcysteine and Methylprednisolone for Patients with Severe Acute Alcoholic Hepatitis

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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 treatment of Severe Acute Alcoholic Hepatitis, a serious liver condition caused by excessive alcohol consumption. The study will use a combination of two medications: methylprednisolone, a type of steroid that helps reduce inflammation, and N-acetylcysteine (NAC), which is often used to help protect the liver. The purpose of the study is to evaluate how effective this combination is in reducing the risk of death within one month for patients suffering from this condition.

Participants in the study will receive the treatment through intravenous perfusion, which means the medication will be administered directly into the bloodstream. The study will monitor the patients over a period of time to assess not only the one-month mortality rate but also the mortality rates at three and six months. Additionally, the study will look at other factors such as liver complications, infections, kidney problems, and how well patients tolerate the NAC treatment.

The study will also explore the relationship between the Lille index, a score used to predict the outcome of treatment in patients with severe alcoholic hepatitis, and the response to the treatment after seven days. This research aims to provide valuable insights into the potential benefits of using methylprednisolone and NAC together for treating severe cases of alcoholic hepatitis.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, gender, and diagnosis of acute alcoholic hepatitis with a Maddrey score of 32 or higher.

  2. Step 2

    Consent and enrollment

    Written informed consent is obtained to confirm willingness to participate in the study.

  3. Step 3

    Treatment initiation

    The treatment involves the administration of two medications: methylprednisolone and N-acetylcysteine (NAC).

    Both medications are given through intravenous perfusion.

  4. Step 4

    Medication administration

    The dosage and frequency of administration are determined by the study protocol and are monitored by the medical team.

  5. Step 5

    Monitoring and follow-up

    Regular monitoring is conducted to assess the efficacy of the treatment in terms of mortality at one month.

    Additional assessments are made at three and six months to evaluate mortality, liver complications, infections, renal failure, and tolerance to NAC.

    The relationship between the Lille index at day 7 and the response to treatment is also evaluated.

  6. Step 6

    Completion of study

    The study is estimated to end by December 30, 2025. Participants will be informed of the study's findings and any relevant health information.

Who can join the trial?

5 criteria

  • Both males and females can participate.
  • Participants must be between the ages of 18 and 75.
  • Participants need to have a diagnosis of acute alcoholic hepatitis, which is a liver condition caused by excessive alcohol consumption. This diagnosis should follow specific guidelines or be confirmed by a liver tissue examination.
  • Participants must have a Maddrey Score of 32 or higher. The Maddrey Score is a calculation used to determine the severity of alcoholic hepatitis.
  • Participants must be willing to join the study and provide their agreement by signing a written informed consent, which is a document that explains the study and confirms their voluntary participation.

Who cannot join the trial?

6 criteria

  • Patients who are not diagnosed with Severe Alcoholic Hepatitis cannot participate. This condition is a serious liver disease caused by excessive alcohol consumption.
  • Patients who are under 18 years old or over 65 years old are not eligible to join the study.
  • Patients who are part of a vulnerable population, such as those who cannot give informed consent, are excluded from the study.
  • Patients who are pregnant or breastfeeding cannot participate in the study.
  • Patients who have other serious health conditions that might interfere with the study treatment are not eligible.
  • Patients who are currently participating in another clinical trial are excluded from this study.
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Investigated drugs

  • Methylprednisolone

    is a medication used to reduce inflammation in the body. In this trial, it is being used to help manage severe alcoholic hepatitis, a condition where the liver becomes inflamed due to excessive alcohol consumption. The goal is to see if it can improve survival rates in patients with this condition.

  • N-acetylcysteine (NAC)

    is a medication that helps to protect the liver from damage. It is often used to treat liver issues and is being tested in this trial to see if it can enhance the effects of methylprednisolone in treating severe alcoholic hepatitis. The combination aims to improve patient outcomes by reducing liver inflammation and damage.

What is already known about the treatment

  • N-acetylcysteine

    N-acetylcysteine is administered orally or intravenously and is currently being studied for its potential benefits in treating severe acute alcoholic hepatitis. It is commonly used as a mucolytic agent and an antidote for acetaminophen overdose. In this context, it is being evaluated for its ability to reduce liver damage by replenishing glutathione levels, which helps neutralize harmful substances in the liver. N-acetylcysteine is classified as an antioxidant and hepatoprotective agent.

  • Methylprednisolone

    Methylprednisolone is administered orally or intravenously and is a well-established medication in the treatment of inflammatory and autoimmune conditions. It is being investigated for its effectiveness in reducing mortality in patients with severe acute alcoholic hepatitis. Methylprednisolone works by suppressing the immune response and reducing inflammation in the liver. It belongs to the pharmacological class of corticosteroids.

Investigated diseases

Acute Alcoholic Hepatitis – This is a severe liver condition caused by excessive alcohol consumption. It is characterized by inflammation of the liver, which can lead to symptoms such as jaundice, abdominal pain, and nausea. The disease progresses as liver cells are damaged, leading to impaired liver function. Over time, this can result in the accumulation of toxins in the body, as the liver is less able to filter them out. The condition can also cause fluid buildup in the abdomen and increased risk of infections. It is important to manage alcohol intake to prevent further liver damage.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-510163-35-00Protocol codeCONACHAAEstimated enrolment180 patientsSponsorAsociacion Instituto De Investigacion Sanitaria Bioaraba

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