RecruitingPHASE3INTERVENTIONAL

Personalized Long-term Human Albumin Treatment in Patients With Decompensated Cirrhosis and Ascites

This study is for people with severe liver scarring (decompensated cirrhosis) and fluid build-up in the tummy (ascites). Researchers want to find out if a special blood test, called a biomarker panel, can help identify which patients are most likely to benefit from regular infusions of human albumin. Albumin is a protein found in the blood. Currently, albumin is given based on general guidelines, but this study hopes to make treatment more personalised and effective. Participants will receive either regular albumin infusions or a saltwater solution. The study aims to see if this new approach can reduce the number of serious liver-related problems patients experience, making treatment more targeted and potentially reducing unnecessary treatments.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Aleksander Krag

Enrolment target

240

Start

26 Feb 2024

Estimated completion

01 Sep 2026

Decompensated Cirrhosis and Ascites

What is this study about?

This clinical trial is looking at new ways to help people with severe liver scarring, known as decompensated cirrhosis. This condition often leads to fluid building up in the tummy, a symptom called ascites. Currently, people with cirrhosis and ascites are sometimes given regular infusions of human albumin, which is a protein found in the blood. These infusions can help manage the fluid build-up and support liver function.

The main idea behind this study is to make treatment with albumin more individual and effective. Researchers want to use a special kind of blood test, called a "biomarker panel," to help predict who will get the most benefit from these albumin infusions. If this test works, it could help doctors choose the best treatment for each patient, ensuring that those who need albumin infusions get them, and those who might not benefit as much don't receive unnecessary treatment.

Participants in the study will be divided into groups based on the results of their biomarker panel. They will then be randomly chosen to receive either regular infusions of human albumin or a saltwater solution (which acts as a comparison). The researchers will then carefully compare how these different treatments affect things like the number of liver-related problems patients have. The goal is to see if using this biomarker panel can lead to better outcomes and a more targeted approach to care for people living with decompensated cirrhosis and ascites.

Key takeaways

This study explores a new way to personalise treatment for severe liver scarring and fluid build-up.
It uses a blood test to predict who might benefit most from albumin infusions.
Participants will receive either albumin or a saltwater solution by IV over 6 months.
The goal is to reduce serious liver problems and make treatment more effective.
You can withdraw from the study at any time without affecting your care.

Who may be eligible?

To join this study, you must be at least 18 years old and have severe liver scarring (decompensated cirrhosis) with fluid in your tummy (ascites). You also need to have been free from any recent serious liver problems or hospital stays for at least five days.

There are several reasons why someone might not be able to join. For example, if your liver failure is very sudden, or if you have certain other serious health conditions like advanced heart or lung disease, severe kidney problems requiring dialysis, or certain severe mental health conditions. If you've had a liver transplant or are pregnant or breastfeeding, you also wouldn't be able to take part.

In addition, if you have certain types of severe infections, severe inflammation of the liver due to alcohol, or specific conditions affecting blood flow in your liver, you might not be eligible. The team will carefully check all these details to ensure the study is safe and suitable 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 18 years old or older?
Do you have severe liver scarring (cirrhosis) with fluid in your tummy (ascites)?
Have you been free from recent serious liver problems or hospital stays for at least 5 days?
Are you pregnant or breastfeeding?
Do you have severe other health conditions like advanced heart or kidney disease?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll first have a special blood test called a biomarker panel. This test will help researchers understand if you're likely to get a high or low benefit from human albumin infusions. Based on these results, you'll then be randomly assigned to one of two treatment groups. This means you won't get to choose which group you're in – it's like flipping a coin.

One group will receive regular infusions of human albumin, which will be given every 10 days over a period of 6 months. The other group will receive infusions of a saltwater solution, also every 10 days for 6 months. These infusions are given through a drip, just like in a hospital.

Throughout the 6 months, researchers will monitor your health closely and compare the effects of the two treatments on any liver-related events you might experience. After the 6-month treatment period, there will likely be follow-up appointments to continue monitoring your health. The total duration of active treatment in the study is 6 months, with additional follow-up likely.

Potential risks and benefits

Participating in any clinical trial involves potential benefits and risks. A potential benefit of this study is that you might receive regular albumin infusions, which could help manage your liver condition and potentially reduce serious liver-related problems. The study also aims to make treatments more targeted, which could be beneficial in the long run for patients like you. However, you might also receive the saltwater solution, which acts as a comparison and doesn't have the same direct effects as albumin. Potential risks could include side effects from the infusions, such as allergic reactions to albumin (though these are rare) or discomfort at the infusion site. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (12)

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

Katholieke Universiteit Leuven
Verified postcode
Leuven, Belgium· Recruiting
Herlev Hospital
Verified postcode
Herlev, Denmark· Recruiting
Odense University Hospital
Verified postcode
Odense, Denmark· Recruiting
Charité - Universitätsmedizin Berlin
Verified postcode
Berlin, Germany· Recruiting
Universitätsklinikum Jena
Verified postcode
Jena, Germany· Recruiting
Universitätsklinikum Münster
Verified postcode
Münster, Germany· Recruiting
Debreceni Egyetem
Verified postcode
Debrecen, Hungary· Recruiting
Academisch Ziekenhuis Leiden
Verified postcode
Leiden, Netherlands· Recruiting
Alrijne Ziekenhuis Leiden
Verified postcode
Leiderdorp, Netherlands· Recruiting
Hospital Clinic Barcelona
Verified postcode
Barcelona, Spain· Recruiting
Hospital Del Mar
Verified postcode
Barcelona, Spain· Recruiting
King's College Hospital
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is decompensated cirrhosis?

Decompensated cirrhosis means your severe liver scarring (cirrhosis) has started causing serious problems, like fluid build-up in your tummy (ascites) or confusion.

What is human albumin?

Human albumin is a protein found in your blood. It helps keep fluid in your blood vessels and carries important substances around your body. Infusions can help replace it if your liver isn't making enough.

What is a biomarker panel?

A biomarker panel is a special blood test that looks for specific signs in your blood that can help doctors understand your condition better and predict how you might respond to treatments.

Will I know if I'm getting albumin or saltwater?

No, you won't know if you're receiving the human albumin or the saltwater solution. This is called 'blinding' and helps ensure the study results are fair and accurate.

How long will the treatment last?

The regular infusions will last for 6 months, with an infusion given every 10 days during that time. There might be follow-up appointments after this period.

How to find out more

Aleksander Krag, Professor

albtrial@rsyd.dk +4566113333 Official trial record

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