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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Lille Lille France
Oncopole Claudius Regaud Toulouse France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nice Nice France
Centre Hospitalier Universitaire De Rennes Rennes France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Centre Hospitalier De Valenciennes Valenciennes France
Centre Hospitalier Universitaire De Caen Normandie Caen France
L’Hopital Alexandra Lepeve Dunkirk France
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Bldplykl Uaohonstlc Hlltblqh Cbmmdn Besançon France
Cmzvaw Hvnoimytxlu Rhbakbmq Uzohprsrdqxpq Dm Tgabr Tours France
Cqbq Du Niyzp Vandoeuvre Les Nancy France
Coriis Hjqkvubdtpo Uhtpzxmxujpdl Rvpzf Reims France
Cnudhc Hgsayayjjee Rlhhahoc Drndibxwdfynyl Angers France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
01.10.2025

Trial locations

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.

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 ID:
2025-522109-39-00
Protocol code:
2024_0476
NCT ID:
NCT06956482
Trial Phase:
Therapeutic confirmatory (Phase III)

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