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Study of N-acetylcysteine and prednisolone combination versus extended prednisolone treatment in patients with severe alcoholic hepatitis

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What is this trial about?

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

This study focuses on treating alcoholic hepatitis, a severe liver condition caused by excessive alcohol consumption. The research evaluates different treatment approaches using two medications: prednisolone, a corticosteroid medication that helps reduce inflammation in the liver, and N-acetylcysteine, a substance that may help protect liver cells from damage.

The study compares three different treatment approaches: standard treatment with prednisolone for 30 days, extended prednisolone treatment for 60 days, or a combination of standard prednisolone treatment with N-acetylcysteine given over 5 days. The purpose is to determine which treatment method is most effective in helping patients recover from severe alcoholic hepatitis and maintain stable liver function after 90 days.

During the study, participants will receive either prednisolone tablets taken by mouth, N-acetylcysteine given through an intravenous line (directly into a vein), or placebo, depending on their assigned treatment group. Some patients will receive additional supportive treatments including dextrose and saline solutions. The study will monitor patients' liver function and overall health throughout the treatment period and follow-up visits.

The research process

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

  1. Step 1

    Initial treatment phase - first 5 days

    You will receive prednisolone (20 mg tablets taken by mouth) as the main treatment

    Depending on your assigned group, you may also receive N-acetylcysteine through an intravenous infusion (5g/25ml) during these first 5 days

  2. Step 2

    Continued treatment - days 6-30

    You will continue taking prednisolone tablets by mouth

    Your liver function will be monitored through blood tests to calculate your MELD score (a measure of liver health)

  3. Step 3

    Extended treatment phase - days 31-60

    Depending on your assigned group, you may continue taking prednisolone tablets for an additional 30 days

    Some participants will stop treatment at day 30, while others will continue until day 60

  4. Step 4

    Follow-up evaluations - day 90

    Your liver function will be assessed through blood tests to calculate your MELD score

    The medical team will evaluate your overall health status and liver condition

  5. Step 5

    Long-term follow-up - up to 360 days

    Additional health assessments will be conducted at day 180 and day 360

    Your liver function and overall health status will continue to be monitored through regular check-ups

Who can join the trial?

9 criteria

  • Age between 18 and 75 years old
  • Regular alcohol consumption exceeding:
    • 40 grams per day for women
    • 50 grams per day for men
    • Recent yellowing of the skin and eyes (jaundice) that started less than 3 months ago
    • Confirmed alcoholic hepatitis through a special liver tissue sample (transjugular liver biopsy)
    • A Maddrey's score of 32 or higher (a medical calculation that measures the severity of liver disease)
    • A MELD score of 17 or higher (another medical score that evaluates how severe liver disease is)
    • Must have active social insurance coverage
    • Must be willing and able to provide written informed consent to participate in the study

Who cannot join the trial?

14 criteria

  • People under 18 or over 75 years old cannot participate
  • Patients with severe liver failure (when the liver stops working properly)
  • People with active bleeding in their digestive system
  • Those with active infections that are not under control
  • Patients who have kidney failure (when kidneys don't work properly)
  • People who are allergic to prednisolone (the study medication) or N-acetylcysteine
  • Pregnant women or women who are breastfeeding
  • People with autoimmune hepatitis (when the immune system attacks the liver)
  • Patients with other serious medical conditions that could affect their participation
  • Those who are currently participating in other clinical trials
  • People who cannot understand or follow the study instructions
  • Patients who have had an organ transplant
  • Those with hepatocellular carcinoma (liver cancer)
  • People with a history of drug abuse in the past 6 months
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Investigated drugs

  • Prednisolone

    This is a corticosteroid medication used to reduce inflammation in the liver. It's commonly used as a standard treatment for severe alcoholic hepatitis. This medication helps to decrease inflammation and suppress the immune system response that contributes to liver damage.

  • N-acetylcysteine

    This is an antioxidant medication that helps protect the liver from damage. It works by supporting the body's natural antioxidant systems and can help reduce inflammation. It's often used in combination with other treatments to improve liver function in patients with severe liver conditions.

What is already known about the treatment

  • Prednisolone

    A synthetic corticosteroid medication taken orally in tablet form or administered intravenously, widely used in modern medicine as a standard treatment for severe alcoholic hepatitis. This drug works by suppressing the immune system and reducing inflammation in the liver, acting on glucocorticoid receptors to decrease inflammatory responses at the cellular level. As a member of the glucocorticoid class of medications, prednisolone is typically prescribed in a tapering dose over 30 days for treating severe alcoholic hepatitis.

  • N-Acetylcysteine

    A medication that can be administered orally or intravenously, commonly used as an antioxidant and mucolytic agent in various liver conditions. It works by replenishing glutathione stores in the liver cells, providing protection against oxidative stress and cell death, while also having anti-inflammatory properties. This compound belongs to the class of antioxidant medications and is being studied in combination with prednisolone for potential enhanced therapeutic effects in severe alcoholic hepatitis treatment.

Investigated diseases

Alcoholic hepatitis - An inflammatory condition of the liver caused by heavy alcohol consumption over an extended period. The disease develops when alcohol damages liver cells, leading to inflammation and swelling in the liver tissue. It can occur suddenly, marked by symptoms such as jaundice (yellowing of the skin and eyes), abdominal pain, and nausea. The condition can vary in severity, with some people experiencing mild symptoms while others develop more serious manifestations. Continued alcohol consumption during the disease can worsen the liver damage and inflammation.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522109-39-00Protocol code2024_0476Estimated enrolment477 patientsSponsorCentre Hospitalier Universitaire De Lille

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