AuthorisedTherapeutic confirmatory (Phase III)Interventional

Utility of the use of N-acetylcysteine associated with conventional treatment in patients with severe acute alcoholic hepatitis (Maddrey>=32)

This research study is for people in the UK who have severe alcoholic hepatitis, a serious liver condition caused by heavy drinking. Doctors are testing a new approach, adding a medicine called N-acetylcysteine (NAC) to the usual treatment, which typically includes methylprednisolone, a steroid. The main goal is to see if this combination helps more people survive the first month after diagnosis. They will also check survival rates at three and six months. Researchers are also watching for potential problems like other liver complications, infections, and kidney issues, and how well people tolerate the new medication. This is a very important study to find better ways to treat this serious condition.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Asociacion Instituto De Investigacion Sanitaria Bioaraba

Enrolment target

180

Start

15 Jan 2025

Acute Alcoholic hepatitis

What is this study about?

This research study is about a severe liver condition called alcoholic hepatitis. This condition happens when the liver gets very inflamed and damaged due to heavy drinking. When it's severe, it can be very serious and sometimes life-threatening. Doctors usually treat severe alcoholic hepatitis with a medicine called methylprednisolone, which is a type of steroid designed to reduce the inflammation.

In this study, doctors want to see if adding another medicine, called N-acetylcysteine (NAC), to the standard methylprednisolone treatment can make a difference. NAC is a medication that has different uses, and in this case, researchers are hoping it might help protect the liver and improve how well people recover. The main thing they want to find out is if people treated with both medicines have a better chance of surviving the first month compared to those receiving only the standard treatment.

Beyond the first month, the researchers will also be checking on people's health at three and six months to see how they are doing. They will also carefully watch for any other problems that might come up, such as further liver issues, infections, or kidney problems. They want to understand how well people tolerate the full treatment and if there's a link between early treatment response and longer-term outcomes. The aim is to find the best possible way to help patients with this serious illness.

Key takeaways

This study explores a new treatment for severe alcoholic hepatitis.
It combines standard medicine (steroids) with a new medicine (NAC).
The main aim is to improve survival within the first month.
Researchers will also track other health problems and recovery over 6 months.
It's for adults with severe alcoholic hepatitis in the UK.
Participation involves close monitoring and follow-up.

Who may be eligible?

To be able to take part in this study, you would need to be an adult, 18 years old or older. The study includes both men and women.

The most important criteria is that you must have a severe form of acute alcoholic hepatitis. This is a specific diagnosis made by doctors based on certain tests and symptoms.

Further specific medical conditions or treatments might mean you can't join, as the study needs to ensure it's safe for participants and that the results are clear. Your doctor will be able to tell you if you meet all the requirements.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with severe acute alcoholic hepatitis?
Are you able to attend regular check-ups and tests?
Are you living in the UK and able to participate at a study site?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you will receive treatment for your severe alcoholic hepatitis. This treatment will include the standard medication, methylprednisolone, and you may also receive N-acetylcysteine (NAC).

Doctors will closely monitor your health throughout the study. This will likely involve regular check-ups, blood tests, and possibly other scans or tests to see how your liver is responding and to keep an eye on any side effects. These assessments will help the doctors understand if the treatment is working and if it's safe for you. The main focus will be on your health during the first month, but ongoing follow-up will continue for up to six months to see how you recover over time. Appointments may be frequent initially and then become less frequent.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that you might receive a treatment combination that could be more effective for your severe alcoholic hepatitis than standard care alone, potentially leading to a better outcome. However, there's no guarantee the new combination will work better for you, or at all. Potential risks could include side effects from the medications, which your doctor will explain in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Spain

Common questions

What is alcoholic hepatitis?

Alcoholic hepatitis is a severe inflammation and damage to the liver caused by heavy drinking over time. It can be very serious.

What is N-acetylcysteine (NAC)?

NAC is a medicine that doctors are testing to see if it helps protect the liver and improve recovery when given alongside standard treatment for alcoholic hepatitis.

What is the main goal of this study?

The main goal is to find out if adding NAC to the usual treatment helps people with severe alcoholic hepatitis survive the first month after diagnosis.

Will I know if I'm getting NAC or just the standard treatment?

This information will be explained by your doctor. Sometimes in studies like this, participants don't know which treatment they are receiving to keep the results fair and unbiased.

How long will I be followed in this study?

Your health will be closely watched for up to six months to see how you recover over time.