RecruitingNAINTERVENTIONAL

A Novel Extracorporeal Liver Support Therapy In ALCF and to Evaluate the Efficacy of DIALIVE 2.0, a Liver Dialysis Device.

This research study is looking at a new treatment called DIALIVE 2.0, which acts like a 'liver dialysis' machine. It's designed for people who have severe liver failure, known as 'acute-on-chronic liver failure' (ACLF), where their liver has suddenly got much worse. The study wants to find out if using the DIALIVE 2.0 device alongside standard hospital care can improve health outcomes for these patients. Around 72 adults aged 18 to 70 with a history of liver scarring (cirrhosis) and recent worsening of their liver condition will take part in hospitals across the UK. Participants will either receive standard care or standard care plus up to seven sessions of the DIALIVE 2.0 treatment.

At a glance

Status

Recruiting

Phase

Sponsor

Yaqrit Ltd

Enrolment target

Start

01 Oct 2026

Estimated completion

01 May 2027

Acute-on-Chronic Liver Failure (ACLF)Liver Cirrhosis

What is this study about?

This study is about a new way to help people with a serious liver condition called acute-on-chronic liver failure (ACLF). This happens when someone with long-term liver scarring (cirrhosis) suddenly gets much sicker. Your liver does many vital jobs, like cleaning your blood and making important proteins. When it fails, harmful toxins can build up in your body, making you very unwell.

The new treatment being tested is a 'liver dialysis' device called DIALIVE 2.0. Think of it like a kidney dialysis machine, but for the liver. It works by cleaning your blood outside your body, removing harmful substances that your failing liver can no longer handle. It also helps to replace important proteins that your body needs, trying to give your liver a chance to recover or to keep you stable until other treatments are possible.

The main goal of this study is to see how well the DIALIVE 2.0 device works and if it's safe when used along with the usual hospital treatments. We want to find out if it can improve the health of people with this type of severe liver failure. The study will compare patients who receive the DIALIVE 2.0 treatment plus standard care against those who only receive standard care, to understand if the new device makes a positive difference.

Key takeaways

This study is testing a new 'liver dialysis' device called DIALIVE 2.0 for severe liver failure.
It aims to see if DIALIVE 2.0, with standard care, helps patients more than standard care alone.
Around 72 adults aged 18-70 with worsening liver cirrhosis will take part across the UK.
Participants will either get standard care or standard care plus up to 7 DIALIVE 2.0 sessions.
The study lasts about 105 days per person, including monitoring and follow-up.
You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

To be able to join this study, you would typically need to be an adult between 18 and 70 years old. You must have been diagnosed with a severe form of liver failure called acute-on-chronic liver failure (ACLF) that has gotten worse quite quickly, specifically within the last 10 days, and hasn't responded to initial standard hospital care within 48 hours. This condition means you already have long-term liver damage (cirrhosis) that has suddenly become much worse.

There are also some reasons why you might not be able to join. For example, if you are pregnant, have certain severe infections that aren't getting better with treatment, or have advanced HIV that's causing specific health problems. People who have already had a liver transplant, have very low blood platelet counts, or problems with blood clotting, or very unstable blood pressure and breathing difficulties, would also not be able to take part. This is to make sure the study is as safe as possible for everyone involved.

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 between 18 and 70 years old?
Do you have a history of liver scarring (cirrhosis)?
Has your liver condition recently gotten much worse (ACLF) within the last 10 days?
Have standard treatments for your liver condition not improved things much in the last 48 hours?
Are you *not* pregnant and do you *not* have certain severe, untreatable infections?
Have you *not* had a liver transplant before?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, your journey would last for about 105 days. First, there's a quick check-up (screening) over about 5 days to make sure you're suitable. If you are, you'll then be randomly put into one of two groups, like flipping a coin. One group will receive the usual hospital care for your condition. The other group will receive the usual care PLUS up to seven sessions of the DIALIVE 2.0 'liver dialysis' treatment, typically one session per day, over a 10-day period.

Each DIALIVE 2.0 session would last between six and eight hours, during which your blood is gently circulated through the device outside your body to be cleaned. Throughout the study, the medical team will closely monitor your health. After your treatment period, there will be follow-up checks over the next 90 days to see how you're doing. This involves regular appointments and tests, similar to what you might already have for your condition.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that the DIALIVE 2.0 treatment might help your liver function improve, reduce harmful toxins in your body, and potentially improve your overall health more than standard care alone. However, there's no guarantee it will help you personally. Potential risks could include side effects from the treatment itself, such as issues related to blood clotting or infections, as your blood is circulated outside your body. The medical team will monitor you closely for any problems. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Royal Free Hospital
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is 'liver dialysis'?

It's a treatment that cleans your blood outside your body, removing harmful substances when your liver isn't working well, similar to how kidney dialysis works.

How long will I be in the study?

The study lasts up to 105 days in total, including initial checks, the treatment period, and follow-up appointments.

Will I definitely get the new treatment?

Not necessarily. Participants are randomly assigned to either receive the new treatment plus standard care, or standard care alone. It's like flipping a coin.

What is 'acute-on-chronic liver failure' (ACLF)?

It's a serious condition where someone with long-term liver damage (cirrhosis) suddenly experiences a rapid and severe worsening of their liver function.

Is the DIALIVE 2.0 device approved for general use?

No, it's an investigational device being tested in this clinical trial to see if it's safe and effective before it could become widely available.

How to find out more

Carrie Morgan

carrie.morgan@yaqrit.com +44 (0) 7970771628 Official trial record

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