Randomized, placebo-controlled, double blind, multi-centre Phase IIb stuDy to evaluate the efficacy and safety of HepaStem in patients with Acute on Chronic Liver Failure (ACLF) – DHELIVER
The DHELIVER study is looking into a new treatment called HepaStem for a serious liver condition known as Acute on Chronic Liver Failure (ACLF). ACLF happens when someone with existing liver disease suddenly gets much sicker, often affecting other organs in the body and leading to a high risk of death. HepaStem is being compared to a 'dummy' treatment (placebo) to see if it can improve survival rates and general health. Researchers will carefully monitor how participants respond, checking their liver function, overall health, and any side effects over 90 days. This study hopes to find a new way to help people suffering from this challenging condition.
At a glance
What is this study about?
The DHELIVER study is investigating a new treatment called HepaStem for a very serious liver condition. This condition is known as Acute on Chronic Liver Failure (ACLF). ACLF happens when someone who already has a long-term liver problem (like cirrhosis) suddenly gets much worse. It's not just the liver that's affected – other important organs in the body can also start to fail, which makes people very unwell and sadly means they are at a high risk of not surviving.
ACLF often involves a lot of inflammation in the body, which can make the organ failure worse. We are hoping that HepaStem might help to calm this inflammation and support the body in recovering. In this study, some people will receive HepaStem, and others will receive a 'placebo', which looks identical but doesn't contain any active medicine. This is a common way to test new treatments fairly.
The main goal of the study is to see if HepaStem helps people live longer. The researchers will be checking on participants for 90 days to see if they are still alive. They will also look at how liver function changes, if people need liver transplants, how long they stay in hospital, and carefully record any side effects. This detailed approach helps us understand if HepaStem is both effective and safe for people with ACLF.
Key takeaways
- This study is testing a new treatment (HepaStem) for serious liver failure (ACLF).
- It aims to see if HepaStem can help people live longer and improve their health.
- Some participants will receive HepaStem, others a 'dummy' treatment (placebo).
- Your health will be closely monitored for 90 days.
- You must be an adult with ACLF currently in hospital to be considered.
Who may be eligible?
To be considered for this study, you must be an adult aged 18 or over. This study is open to both men and women.
Crucially, you must have been diagnosed with Acute on Chronic Liver Failure, or ACLF, and be currently in hospital because of it. ACLF means you have a long-term liver problem (like cirrhosis) that has recently become much worse, affecting other organs in your body.
The study team will review your medical history and current health carefully to make sure this study is right for you, and that you meet all the specific criteria needed to take part safely.
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?
- Are you currently in hospital for liver problems?
- Have you been told you have Acute on Chronic Liver Failure (ACLF)?
- Do you have a long-term liver problem that has recently got worse?
What does participation involve?
If you decide to take part in the DHELIVER study, you will receive either the investigational treatment HepaStem or a placebo (a dummy treatment) intravenously, which means directly into a vein. Researchers will then closely monitor your health over a period of 90 days. This will involve regular check-ups, which include physical examinations, checking your vital signs (like blood pressure and heart rate), and collecting blood and urine samples for various laboratory tests to monitor your liver function, general health, and any possible side effects. They will also keep track of how long you stay in the hospital, both in general and in intensive care. All serious health events will be carefully recorded. You will be followed up for 90 days after receiving the treatment.
Potential risks and benefits
Locations (14)
- —UnverifiedDenmark
- —UnverifiedPoland
- —UnverifiedBulgaria
- —UnverifiedNetherlands
- —UnverifiedSlovakia
- —UnverifiedLatvia
- —UnverifiedLithuania
- —UnverifiedGermany
- —UnverifiedBelgium
- —UnverifiedAustria
- —UnverifiedFrance
- —UnverifiedEstonia
Common questions
What is ACLF?
ACLF (Acute on Chronic Liver Failure) is when someone with existing long-term liver disease suddenly gets much sicker, often with other organs failing too.
What is HepaStem?
HepaStem is the new treatment being tested in this study to see if it can help people with ACLF.
What is a 'placebo'?
A placebo is a 'dummy' treatment that looks like the real medicine but contains no active ingredients. It's used to compare against the real treatment.
How long will I be in the study?
You will be followed and monitored for 90 days after receiving the treatment.
Can I leave the study at any time?
Yes, you have the right to withdraw from the study at any time without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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