RecruitingNAINTERVENTIONAL

Fine Needle Aspiration (FNA) Evaluation of the Intrahepatic HBV Reservoir and Its Immunological Characteristics in Chronically HBV-infected Patients

This research is looking into chronic hepatitis B (`hep B`), a long-term infection affecting millions worldwide. Current treatments don't fully get rid of the virus for most people. Researchers need to understand how the virus survives in the liver and how the body's defence system (immune system) responds. They will use a thin needle to take tiny samples from the liver. This method, called Fine Needle Aspiration (FNA), is similar to how doctors check for lumps. The goal is to collect information that will help develop new and more effective medicines to clear the virus completely from the body, leading to a 'functional cure'.

At a glance

Status

Recruiting

Phase

Sponsor

Hospices Civils de Lyon

Enrolment target

100

Start

08 Mar 2024

Estimated completion

08 Mar 2030

Chronic Hepatitis b

What is this study about?

Hepatitis B (`hep B`) is a viral infection that can cause serious liver problems if it becomes long-term, or chronic. Despite existing treatments, the virus often stays hidden in the liver, leading to ongoing health concerns for many people. This study aims to get a much clearer picture of why this happens and how the body's immune system tries to fight it off.

Researchers believe that by understanding these complex interactions right where the virus lives – in the liver – they can find new ways to tackle the infection. They will be looking at both the virus itself and the body's immune response in the liver samples. This deeper knowledge is crucial for developing new drugs that could achieve what's called a 'functional cure' for `hep B`. A functional cure means the virus would no longer be active and causing problems, even after stopping treatment.

To collect these important samples, doctors will use a method called Fine Needle Aspiration (FNA). This technique involves using a very thin needle to take a small sample of liver cells. It's a method that is less invasive than a full liver biopsy and has been shown to be safe and effective for gathering information about the liver. The information gathered from this study could help doctors understand which patients might benefit from stronger treatments or even safely stop their current medication.

Key takeaways

Study aims to understand why `hep B` persists in the liver.
Uses a thin needle (FNA) to collect small liver samples.
Goal is to find better ways to achieve a 'functional cure' for `hep B`.
Participation involves an FNA procedure, questionnaires, and blood samples.
Open to adults with chronic `hep B`, including those with `HDV` and on treatment.
No direct personal health benefit, but contributes to future patient care.

Who may be eligible?

This study is looking for adults aged 18 or over who have chronic hepatitis B (`hep B`). This includes people who are currently taking medication for `hep B` as well as those who are not. If you also have hepatitis Delta (`HDV`) alongside your `hep B`, you might still be able to take part.

To be considered for the study, you must already be part of another research project called the CirB-RNA study and have given your permission to take part by signing a consent form.

There are certain situations that would prevent someone from joining. For example, if you are pregnant, breastfeeding, or have advanced liver scarring (decompensated cirrhosis). People with liver cancer, those who have had a liver transplant, or who also have HIV or Hepatitis C cannot join. You also can't be taking part in another medical study, be under psychiatric care, or have certain skin conditions on your abdomen. Also, if you're allergic to lidocaine (a local anaesthetic that numbs the skin) or are under legal protection like guardianship, you cannot participate.

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.

Am I 18 years old or older?
Do I have chronic hepatitis B?
Am I already part of the CirB-RNA study?
Am I not pregnant, breastfeeding, or have severe liver scarring (decompensated cirrhosis)?
Do I not have liver cancer, HIV, or Hepatitis C?
Am I not allergic to lidocaine?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the main procedure will involve a Fine Needle Aspiration (FNA). This is where a very thin needle is used to take a small sample from your liver. This will be done with local anaesthetic to numb the area. You will also be asked to complete a questionnaire about your experience with the FNA procedure to help researchers understand how acceptable and comfortable it is. Blood samples will also be collected for a 'biobank', which is a collection of samples stored for future research. The total duration of your participation in this study is not specified, but it's important to discuss the time commitment with the study team.

Potential risks and benefits

Participating in this study might offer a small benefit of contributing to a better understanding of hepatitis B, potentially leading to new and improved treatments for future patients. However, there's no direct personal medical benefit from taking part. The main risk involves the FNA procedure, which carries a small chance of discomfort, bleeding, or infection, similar to any medical procedure involving needles. You will have a questionnaire to complete afterwards to assess how you found the procedure. Remember, taking part is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Hepatology Department - Hospices Civils de Lyon
Verified postcode
Lyon, France· Recruiting

Common questions

What is Fine Needle Aspiration (FNA)?

It's a procedure where a very thin needle is used to take a small sample of cells from an organ, like your liver, for examination. It's often less invasive than a full biopsy.

What is a 'functional cure' for hepatitis B?

A 'functional cure' means the `hep B` virus would no longer be active in your body, even after stopping treatment, and would not be causing health problems. It's not a complete eradication, but the best outcome currently hoped for.

Why do researchers need liver samples?

The liver is where the `hep B` virus hides and causes problems. Samples from the liver help researchers understand exactly how the virus survives and how the immune system responds, which is vital for developing new treatments.

Will I get results from my liver sample?

The study aims to gather general information to help all patients. While your individual sample contributes, personal results from the specific tests might not be shared directly with you for this research study.

What is a serum biobank?

It's a collection of blood samples (`serum`) that are carefully stored for future research. It helps scientists study long-term changes and influences related to a condition like `hep B`.

How to find out more

Fabien ZOULIM, PU-PH

fabien.zoulim@chu-lyon.fr 0426109355 Official trial record

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