• Trial status: recruiting
• Trial ID: NCT06380335

What is OPAL?

OPAL is an observational study sponsored by Resolution Therapeutics. 11 hospitals across England and Scotland are participating in the study.

OPAL stands for Observational Study in PArticipants with Liver Cirrhosis.

What is the reason for OPAL?

Advanced cirrhosis can progress in different ways for different people. We do not fully understand how the disease develops after someone has their first liver decompensation event.

How could OPAL help?

The OPAL trial will collect data from routine hospital visits, medical records, and blood tests. This data will help doctors and scientists understand how to better care for people with advanced cirrhosis.

The research will also help companies developing new medicines and treatments. OPAL is sponsored by a company called Resolution Therapeutics.

This is an innovative biotech company with labs in Edinburgh and London. They are working on developing a novel treatment for advanced cirrhosis. The data collected in OPAL will help with future studies of their new treatment. If you decide to participate in OPAL, you would be contributing to medical research that may lead to improved treatments for people like you.

Taking part in the OPAL study

Can I take part in OPAL?

OPAL is focused on people with “decompensated cirrhosis”. If you are interested in taking part you must meet certain criteria, such as:

• be aged 18-75 years old
• have been diagnosed with liver cirrhosis
• must either have had a serious liver-related hospitalization within the past 6 weeks and only one such hospitalization in the last 6 months, or must have a recurring, uncontrollable buildup of fluid in your abdomen that has required multiple removal procedures despite treatment attempts
• be willing and able to comply with study procedures

Not everyone with cirrhosis will be able to take part. For example, you will not be able to join the study if you:

• have liver cirrhosis due to primary biliary cholangitis or viral hepatitis
• have a MELD score lower than 12 or higher than 20 (your Meld score is calculated by your doctor using a blood test)
• are on, or plan to be on, immunosuppressive medicines (with some exceptions)
• currently (or in the past 3 months) drink more than 3 units of alcohol every day for women or more than 4 units per day for men.

Find out more about alcohol units here.

The full list of criteria is available here:

What do I have to do if I take part?

The study does not involve you taking any new medicines. Instead it follows the normal care you receive.

You might have extra visits and tests if you do not have a routine appointment booked. This is to make sure that certain routine data is collected at the right time. For example, information about your liver health, medicines, and overall health. You might have an extra blood test at these appointments. As a result, you may get more appointments and be more closely monitored by being part of this study.

What to expect if you take part in the study:

• the study sponsor will view your medical records while at the hospital
• you will still have all your normal clinic appointments
• you may have up to 4-5 extra clinic visits
• you will have a blood test, taking about 1-2 teaspoons of blood at each clinic visit. This blood will be used for laboratory analysis to look at how your liver is doing and how much inflammation is associated with your condition

All this takes place over two years. You are free to leave the study at any time without giving a reason. If you leave the study, you will not have the extra appointments. But you will still receive all the normal care for your condition.

Are there any costs/payments for taking part in this study?

There will be no cost to you for taking part in this study. You will be able to claim money to cover travel expenses, meal and time if you need extra clinic visits that do not coincide with your routine appointments.

How do I get involved in OPAL?

There are currently 11 hospitals across England and Scotland participating in the study. If you are being treated for cirrhosis at one of them and you would like to find out more about taking part in OPAL please use the contact details below.