CompletedPhase 0Interventional

Restoring immune function in liver failure

This study aims to understand how to boost the body's natural defences (immune system) in people whose livers are failing. This includes those with a sudden liver shutdown (acute liver failure) or those with existing liver damage (cirrhosis) whose liver suddenly stops working well (acute decompensation). When the liver fails, people are much more likely to get infections, which can make their condition much worse. Researchers are looking into whether a drug called nivolumab can help the immune system fight these infections. The study involves a single dose of the drug and regular blood tests over 20 days. It's hoped this research could lead to new ways to support patients with liver failure.

At a glance

Status

Completed

Phase

Phase 0

Sponsor

Imperial College London

Enrolment target

Start

01 Dec 2022

Estimated completion

31 May 2026

Liver failure (acute liver failure and acute decompensation of cirrhosis)

What is this study about?

When your liver is severely damaged and can no longer work properly, this is called liver failure. This can happen very suddenly, even if your liver was healthy before, or it can happen in people who already have some liver damage (called cirrhosis) but experience a sudden worsening of their condition.

One of the big problems with liver failure is that your body's immune system, which usually fights off infections, doesn't work as well. This makes you much more likely to get serious infections, which can make your liver problem even worse. Currently, there isn't a specific treatment to help fix this immune system weakness in liver failure.

This study wants to find out if a specific type of drug, like nivolumab, can help improve the way immune cells work in people with liver failure. The goal isn't to fix the liver itself, but to help the body fight off infections better. By collecting samples and looking closely at how this drug affects the immune system, researchers hope to discover new ways to protect patients and ultimately improve their care. This is an early stage study, meaning it's mainly about understanding how the drug works in this situation.

Key takeaways

This study explores new ways to support immune function in liver failure.
It aims to reduce infection risk, a common complication of liver failure.
A single dose of nivolumab is given, followed by blood tests over 20 days.
Participation may not directly benefit you, but helps research for future patients.
The study involves people with sudden liver failure or worsening chronic liver disease.

Who may be eligible?

This study is looking for adults aged 18 or older who have serious liver problems. This includes people who have experienced a sudden liver shutdown (acute liver failure) or those with existing liver damage (cirrhosis) whose liver has suddenly stopped working well.

To be considered for the study, you would need to have certain signs of liver failure, such as jaundice (yellow skin or eyes) or a problem with your blood clotting. For those with existing liver damage, criteria like fluid build-up, infection in abdominal fluid, or confusion would be considered.

There are also some reasons why you wouldn't be able to join. For example, if you're already being considered for a liver transplant in the next two months, have certain other serious health conditions like specific types of cancer, untreated infections, or some immune system disorders. Also, if you've already received a similar type of drug or are pregnant or breastfeeding, you wouldn't be able to participate.

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.

Are you 18 years old or older?
Have you recently been diagnosed with sudden (acute) liver failure?
Do you have existing liver damage (cirrhosis) that has recently gotten much worse?
Are you NOT scheduled for a liver transplant in the next two months?
Do you NOT have an active, untreated serious infection?
Are you NOT pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive a single dose of the study drug, nivolumab, which is given as an injection. Before this injection, and then every 5 days for a total of 20 days, blood samples will be taken. These blood samples will help the researchers understand how the drug affects your immune system. The total duration of active participation in the study, involving treatments and assessments, would be about 20 days.

Potential risks and benefits

It's important to know that there's no guarantee you'll personally benefit from taking part in this study. The main goal is to learn more to help future patients. There is a small chance the drug could cause a temporary swelling or irritation of the liver (inflammation). You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Imperial College Healthcare NHS Trust
City only
London, England
Kings College Hospital NHS Trust
City only
London, England
St George's Hospital NHS Trust
City only
London, England

Common questions

What is liver failure?

Liver failure means your liver isn't working properly to clean your blood, digest food, and help your body function. It can be sudden (acute) or a worsening of existing liver damage (cirrhosis).

What is an 'immune system defect'?

This means your body's natural defences (immune system) aren't working as well as they should, making it harder to fight off infections, which is common in liver failure.

What is nivolumab?

Nivolumab is a type of drug that can help boost the immune system. In this study, researchers are testing if it can help the immune system of people with liver failure.

Will taking part cure my liver failure?

No, this study is not expected to restore liver function. The aim is to improve your immune system to help fight infections, which can make liver failure worse.

Who is running this study?

This study is being run from Imperial College London in the UK and is funded by the Medical Research Council.

How to find out more

Mark Thursz

m.thursz@imperial.ac.uk +44 (0)7768 783073 Official trial record

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