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Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Dasatinib and quercetin, a combination of senolytics to treat fibrotic non-alcoholic fatty liver disease; The TRUTH study

The TRUTH study is a research study investigating a new treatment for a common liver condition called non-alcoholic fatty liver disease (NAFLD), specifically when it involves scarring, known as fibrosis. This condition is now often referred to as MASLD. The treatment being tested is a combination of two medicines, dasatinib and quercetin. These drugs are thought to target old or 'senescent' cells that can contribute to liver damage. The main goal of the study is to find out if this drug combination can reduce liver scarring by at least one level, without making the overall liver disease worse, after 21 weeks. Researchers will also look at other aspects of liver health, such as the number of senescent cells and overall well-being, to understand how well the treatment works and if it's safe. It's a Phase II study, meaning it's an early stage of testing for this specific use.

At a glance

Status
Ongoing, recruiting
Phase
Therapeutic exploratory (Phase II)
Sponsor
Amsterdam UMC Stichting
Enrolment target
30
Start
14 Oct 2024

What is this study about?

This study, called The TRUTH study, is looking for new ways to treat a common liver problem called non-alcoholic fatty liver disease (NAFLD), which is now often called MASLD. This condition means there is too much fat in the liver, and over time, it can lead to scarring, known as fibrosis. When the liver becomes scarred, it can’t work as well, and this can lead to serious health issues.

The researchers are testing a combination of two medicines: dasatinib and quercetin. These medicines are believed to work by tackling 'senescent cells' – these are old, damaged cells that stay in the body and can contribute to disease, including liver scarring. By removing or reducing these cells, the hope is that the liver can heal and scarring can improve. This is an early stage study (Phase II), meaning it’s one of the first times this specific combination is being tested for this liver condition.

The main goal is to see if this treatment can reduce the amount of scarring in the liver by at least one step after about 21 weeks, without making the overall liver disease worse. To check this, doctors will take small samples of liver tissue (biopsies) from participants before and after the treatment period. They will also keep a close eye on other health markers, such as blood tests, liver scans, and general well-being, to understand the full picture of how the treatment affects participants.

Key takeaways

  • The study is testing two drugs (dasatinib and quercetin) for liver scarring caused by fatty liver disease (NAFLD/MASLD).
  • It aims to see if liver scarring can be reduced after 21 weeks of treatment.
  • Participation involves regular check-ups, blood tests, liver scans, and liver biopsies.
  • The study is a 'Phase II' trial, meaning it's an early step in testing this treatment.
  • Eligible participants must be at least 18 years old, male or female.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old. The study is open to both men and women.

More specific details about your health and medical history, such as the exact stage of your liver disease, other health conditions you might have, or medications you are currently taking, would determine if you are a good fit for this particular study. These specific criteria help make sure the study includes people who are most likely to benefit from the treatment or for whom the treatment would be suitable and safe to test.

It's important to discuss your full medical history with the study team to see if you meet all the requirements to join.

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.

  1. Are you at least 18 years old?
  2. Do you have non-alcoholic fatty liver disease (NAFLD) or MASLD with fibrosis (scarring)?
  3. Are you able to attend regular appointments and tests over about 21 weeks?
  4. Are you comfortable with the idea of having liver biopsies at the start and end of the study?
Answer every question to see your result.

What does participation involve?

If you join this study, it will last for about 21 weeks. You would receive either the study medication (a combination of dasatinib and quercetin) or a placebo (an inactive substance, like a sugar pill) and wouldn't know which one you're taking. During this time, you would have several appointments where doctors will check your health. This includes regular blood tests to check your liver function, sugar levels, and other general health markers. You would also have special liver scans (Fibroscan) to measure liver stiffness and fat, and potentially an ECG to check your heart. Crucially, you would have a small procedure called a liver biopsy at the beginning and end of the study. This involves taking a very small sample of liver tissue to look at the scarring directly under a microscope. You'll also be asked about your general health and how you feel, often through questionnaires.

Potential risks and benefits

Taking part in a clinical trial has potential benefits and risks. You might benefit from the new treatment if it works, which could improve your liver scarring. You'll also receive close medical attention and monitoring throughout the study. However, there are potential risks, as the study drugs might cause side effects, and procedures like liver biopsies carry small risks. There's also no guarantee the treatment will work for you. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

Common questions

What is NAFLD/MASLD?

NAFLD (Non-alcoholic fatty liver disease), now also called MASLD, is a condition where too much fat builds up in your liver. It's not caused by drinking too much alcohol.

What does 'fibrosis' mean?

Fibrosis means scarring in the liver. If too much scarring happens, it can make it harder for your liver to work properly.

What are dasatinib and quercetin?

Dasatinib and quercetin are medicines being tested. They are thought to help by removing old, damaged cells that can contribute to liver scarring.

Will I know if I'm getting the real medicine or not?

No, this study is 'blinded,' meaning neither you nor the study team will know if you're receiving the active medicine or a placebo (dummy pill) until the study is over.

How long will I be in the study?

The main treatment period for the study is about 21 weeks.

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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