RecruitingPHASE3INTERVENTIONAL

PROlonged Corticosteroid Treatment or N-ACetylcysteine for Severe Alcoholic Hepatitis

This study focuses on severe alcoholic hepatitis, a serious liver condition caused by alcohol. Currently, a steroid called prednisolone is the main treatment, but it doesn't work for everyone. We're exploring two new approaches to improve patient outcomes. Firstly, we're investigating if giving prednisolone for a longer time than usual helps. Secondly, we're testing if adding another medicine, N-acetylcysteine (which is an antioxidant), to prednisolone treatment makes a difference. The aim is to find better ways to reduce deaths and liver damage for people with this condition, as current treatments aren't always enough. We're hoping to find more effective strategies after many years of research in this area.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

University Hospital, Lille

Enrolment target

477

Start

22 May 2026

Estimated completion

01 May 2030

Alcoholic Hepatitis

What is this study about?

Severe alcoholic hepatitis is a serious liver condition that happens because of heavy alcohol use. When someone has a severe form of this condition, they usually need medical treatment. The most common treatment currently is a steroid medicine called prednisolone, taken for about a month. While prednisolone can help some people in the short term, it doesn't work for everyone, and some patients still get worse or don't recover fully. This means doctors are always looking for better ways to treat it.

This study is trying to answer two big questions to improve care. First, we want to see if giving prednisolone for longer than the usual month could help more people recover their liver function. We know that some people heal slowly, and a longer treatment might give their bodies more time to get better. Second, we're looking at another medicine called N-acetylcysteine, which is an antioxidant. Antioxidants can help protect the body from damage, and we want to see if adding this medicine to prednisolone treatment can further improve how patients do.

For a long time, research in severe alcoholic hepatitis hasn't found many new breakthroughs. This study is exciting because it's looking at fresh ideas that could make a real difference. We're not just looking at survival, but also how well the liver recovers overall. By testing these new strategies, we hope to find ways to reduce the number of people who die from this condition and help more patients achieve better liver health in the long run. It's about finding more effective treatments so that fewer people suffer from the long-term effects of severe alcoholic hepatitis.

Key takeaways

This study is testing new ways to treat severe alcoholic hepatitis.
It's looking at whether longer steroid treatment or adding N-acetylcysteine helps more.
The goal is to reduce deaths and improve liver recovery.
Participation involves taking daily medication and regular hospital visits.
You have the right to stop participating at any time.

Who may be eligible?

To join this study, participants need to be between 18 and 75 years old and have a confirmed diagnosis of severe alcoholic hepatitis, usually found through a liver biopsy. You would also need to have recently developed jaundice (yellowing of the skin or eyes) within the last three months, and have a history of regular alcohol consumption. The doctors will also check specific scores (Maddrey's discriminant function and MELD score) to make sure your condition is severe enough for this study. You will also need to be covered by social insurance and agree to take part by providing your written consent.

There are also reasons why someone might not be able to join the study. For example, if you have certain other serious health conditions like liver cancer, uncontrolled bleeding in your gut, or a serious infection that hasn't been treated yet. If you've had a severe allergic reaction to N-acetylcysteine in the past, or if you're already taking certain steroid or immune-suppressing medicines, you wouldn't be able to participate. Also, individuals with certain viral infections like HIV or Hepatitis B would not be eligible.

The overall aim is to make sure the study includes people who have severe alcoholic hepatitis but are otherwise suitable for the treatments being tested, and for whom it would be safe to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Am I between 18 and 75 years old?
Have I been diagnosed with severe alcoholic hepatitis?
Did I develop yellow skin/eyes (jaundice) in the last 3 months?
Do I have a medical insurance coverage?
Do I have any other severe long-term health conditions that aren't related to my liver?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be assigned to one of several treatment groups, like flipping a coin. You might receive the standard prednisolone treatment, a longer course of prednisolone, or a combination of prednisolone with N-acetylcysteine. For some parts of the study, you might also receive a 'placebo' which looks like the active medicine but contains no active ingredients – this helps us understand if the treatment truly works better than nothing. You would be taking medication daily, either by mouth (for prednisolone and its placebo) or intravenously (through a drip for N-acetylcysteine and its placebo).

Throughout the study, you would have regular visits to the hospital or clinic for check-ups. These visits will involve blood tests to monitor your liver function and overall health, physical examinations, and potentially other tests as needed to see how you are responding to treatment. The doctors will closely watch for any side effects. Treatment will typically last for a defined period, often a month or longer depending on the group you're in, with follow-up appointments to check on your recovery after the treatment ends. The total duration of your involvement, including follow-up, will be explained in detail but generally involves several months of monitoring.

Potential risks and benefits

Taking part in this study might offer potential benefits, such as receiving a new or extended treatment approach that could be more effective for severe alcoholic hepatitis than current standard care. However, there's no guarantee you will personally benefit from these experimental treatments. As with any medication, there are potential risks and side effects associated with prednisolone and N-acetylcysteine, which your doctors will discuss with you. These can range from mild to more serious and will be carefully monitored throughout the study. We also constantly review how well the treatments are working and if they are safe. Remember, participating is entirely voluntary, and you have the right to withdraw from the study at any time without affecting your future medical care.

Locations (1)

CHU de Lille, Hôpital Huriez
Verified postcode
Lille, France· Recruiting

Common questions

What is 'alcoholic hepatitis'?

Alcoholic hepatitis is a severe inflammation of the liver caused by heavy alcohol use. It can lead to serious liver damage.

What is prednisolone?

Prednisolone is a type of steroid medicine. It's used in this condition to reduce inflammation in the liver.

What is N-acetylcysteine?

N-acetylcysteine (NAC) is a medicine that acts as an antioxidant. It helps protect the body's cells from damage.

Why are you giving some people a 'placebo'?

A placebo looks just like the real medicine but contains no active ingredients. Using a placebo helps researchers understand if the new treatments genuinely work better than no specific treatment.

How long will the treatment last?

The treatment period varies depending on the group you are in, but typically lasts for at least a month, with follow-up for several months after that.

How to find out more

Alexandre Louvet, Prof.

alexandre.louvet@chu-lille.fr +33 (0)3 20 44 53 03 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.