Active not recruitingOBSERVATIONAL

Study in Patients With Decompensated Liver Cirrhosis

This study, called OPAL, is for people in the UK who have permanent scarring of the liver, known as cirrhosis, and have recently experienced a significant worsening of their liver condition. This worsening might have led to a hospital stay or needing extra medical help as an outpatient. The study aims to follow these individuals over several years to understand how their liver disease changes over time. Researchers will collect information from their usual doctor's appointments and any extra blood tests or assessments needed for the study. By gathering this real-world information, the study hopes to give us a clearer picture of how liver cirrhosis progresses after a serious event. This knowledge is really important because it will help doctors and scientists develop and test new, more effective treatments in the future.

At a glance

Status

Active not recruiting

Sponsor

Resolution Therapeutics Limited

Enrolment target

Start

10 Oct 2023

Estimated completion

03 Apr 2030

Liver Cirrhosis

What is this study about?

Imagine your liver as an essential organ that cleans your blood and helps you digest food. Sometimes, healthy liver tissue gets replaced by scar tissue, which is called cirrhosis. This scarring is permanent and can stop your liver from working properly.

This study is for adults who have cirrhosis and have recently had a 'decompensating event.' This means their liver disease has taken a turn for the worse. For example, they might have developed fluid build-up in their tummy, confusion due to liver problems, or bleeding from veins in the food pipe. These events can be serious and often lead to a hospital stay or needing extra care.

The main goal of this study is to simply watch and learn. We want to understand how the liver disease progresses naturally in people who have had one of these serious events. The information we gather will help researchers in the future when they are testing new medicines or treatments for cirrhosis. By knowing what typically happens to people with this condition, they can better judge if a new treatment is truly helping.

Key takeaways

It's an observational study for people with liver scarring (cirrhosis).
It's for people who have recently had a serious liver problem (decompensation).
It aims to understand how liver disease progresses over time.
Information is collected mostly from your standard medical appointments.
No new treatments or medications are given as part of this study.
The findings will help develop better treatments in the future.

Who may be eligible?

This study is looking for adults aged 18 to 75. You'll need to have a diagnosis of liver cirrhosis, which your doctor would have confirmed through various tests, such as scans, a special fibroscan, or a liver biopsy.

The study is focusing on specific causes of liver disease, including fatty liver disease (like MASLD or Met-ALD) or liver disease caused by alcohol (ALD). If your liver disease is linked to alcohol, you must have completely stopped drinking alcohol at levels considered harmful, and a special blood test will be done to confirm this.

Crucially, you must have recently experienced a significant worsening of your liver disease, like needing to be hospitalised for fluid build-up, confusion, bleeding, kidney problems, or serious infection within the last six weeks of leaving hospital. Alternatively, if you're an outpatient, you might qualify if you’ve needed repeated draining of fluid from your tummy due to ascites in the past six months, even with medication.

Quick self-check

Are you between 18 and 75 years old?
Has a doctor told you that you have liver cirrhosis?
Have you recently had a serious liver-related hospital stay or needed extra medical help for a worsening liver condition?
Are you able and willing to attend appointments and provide information?

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, the study team will follow your health over a long period. Initially, this would be for up to 96 weeks (about a year and nine months). After this, you would be invited to continue in a longer follow-up phase for another three years.

During this time, the researchers will collect information about your health. Much of this will come from your regular doctor's appointments and check-ups that you would already be having as part of your standard care. If certain tests or assessments needed for the study don't happen during your routine visits, you might be asked to come in for extra appointments specifically for the study. These extra appointments might involve blood tests and other assessments. You won't be given any new medications as part of this study, as it's purely about observing how your condition progresses.

Potential risks and benefits

Taking part in this study could help future patients with liver cirrhosis by providing important information that could lead to new treatments. While there are no direct medical benefits for you from taking part, you might feel a sense of satisfaction knowing you're contributing to medical research. The risks involved are generally low, as most of the information is gathered from your existing medical care. Any extra blood tests might cause minor discomfort or bruising. You can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (12)

Hospital Universitario Reina Sofía
Córdoba, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Spain
Bristol Royal Infirmary
Bristol, United Kingdom
Royal Infirmary Edinburgh
Edinburgh, United Kingdom
Leeds Teaching Hospital NHS Trust
Leeds, United Kingdom
Royal Liverpool Hospital
Liverpool, United Kingdom
King's College Hospital
London, United Kingdom
St George's Hospital
London, United Kingdom
St Mary's Hospital
London, United Kingdom
Nottingham University Hospital
Nottingham, United Kingdom
Southampton General Hospital
Southampton, United Kingdom
Sunderland Royal Hospital
Sunderland, United Kingdom

Common questions

What is liver cirrhosis?

It's permanent scarring of the liver, which can stop it from working as well as it should.

What does a 'decompensating event' mean?

It means your liver disease has become worse, leading to new or more severe symptoms, often requiring hospital care.

Will I take new medication in this study?

No, this study is about observing your health using your usual medical care; no new treatments are given.

How long will I be involved?

Initially around 96 weeks (nearly two years), with an option to continue for another three years.

Will my regular doctor still look after me?

Yes, your medical care will continue as normal with your existing doctors.

How to find out more

Official trial record

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