RecruitingOBSERVATIONAL

New HBV Infection Biomarkers: Clinical Characterization and Impact on Management

Doctors are studying whether new blood tests can give a clearer picture of Hepatitis B infection than current methods. Around 300 million people globally have long-term Hepatitis B, which can cause serious liver problems. This research, based in France, aims to find out if new markers, called HBcrAg and HBV RNA, can better predict how the disease will progress and when treatment might be needed, or even stopped. They hope these new tests will help doctors make more informed decisions about patient care and improve understanding of the infection. Patients would have regular check-ups and provide extra blood samples.

At a glance

Status

Recruiting

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

900

Start

28 Nov 2023

Estimated completion

27 Nov 2038

Chronic Hepatitis B Virus (HBV) Infection

What is this study about?

If you have long-term (chronic) Hepatitis B, you'll know that doctors regularly check on your condition using various tests. This often involves looking at how much of the virus is in your blood (HBV DNA) and a specific protein from the virus (HBsAg).

However, these standard tests don't always fully show how active the virus is or predict how your condition might change over time. This new research aims to find better ways to understand and manage Hepatitis B. Researchers are particularly interested in two newer markers, HBcrAg and HBV RNA, which they believe might give a more detailed picture of the infection and potentially help predict future problems like liver damage or liver cancer.

The main goal is to see if these new markers can help predict if the virus might clear up naturally (a process called HBsAg seroconversion) or if they can show which patients are at higher risk of serious liver disease. If successful, these new tests could help doctors make better decisions about when to start or stop antiviral treatments, leading to more personalised and effective care for people with Hepatitis B.

Key takeaways

This study aims to find better ways to monitor long-term Hepatitis B.
It involves collecting extra blood samples during existing appointments.
Researchers are testing new markers (HBcrAg, HBV RNA) to predict disease progression.
Results could help doctors make more tailored treatment decisions in the future.
Participation will not change your current Hepatitis B treatment.
You can stop participating at any time without affecting your care.

Who may be eligible?

This study is looking for volunteers who are aged 18 or older. To be considered, you must have been diagnosed with long-term Hepatitis B (meaning you've tested positive for HBsAg for at least six months) and be receiving care at the Henri Mondor-Albert Chenevier University Hospital group in France.

There are some reasons why you might not be able to join. For example, you can't be part of the study if you've had a liver transplant due to Hepatitis B. Also, pregnant or breastfeeding women, people who can't legally agree to take part, or those not covered by the French Social Security system won't be able to join.

Importantly, if you prefer not to take part, that's absolutely fine, and you wouldn't be included in the study.

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?
Have you been diagnosed with long-term Hepatitis B (HBsAg positive for > 6 months)?
Are you currently receiving care at Henri Mondor-Albert Chenevier University Hospital?
Have you NOT had a liver transplant for Hepatitis B?
Are you NOT pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, your regular medical appointments for Hepatitis B will continue as usual. The main difference will be that during some of these visits, an extra small amount of blood (about 18ml in total, which is roughly a tablespoon and a half) will be collected once a year for research purposes. This is in addition to any blood tests you would normally have.

This extra blood will help researchers study the new markers they are interested in. You will be followed over time, but the study doesn't involve taking any new or experimental medications; it focuses purely on understanding the disease better through these new blood tests. The total duration of your participation would be ongoing as long as you are part of the study and willing to continue.

Potential risks and benefits

Taking part in this study may not offer immediate personal health benefits, as the research is focused on learning more about Hepatitis B for future patient care. However, your participation will be very valuable in helping doctors better understand the disease and potentially improve treatments for everyone with Hepatitis B. The risks are minimal and similar to those of standard blood tests, such as slight bruising or discomfort at the injection site. You have the right to withdraw from the study at any time without giving a reason, and your medical care will not be affected.

Locations (1)

Clinical Research Unit (CRU) Henri Mondor.
Verified postcode
Créteil, France· Recruiting

Common questions

What is chronic Hepatitis B?

Chronic Hepatitis B means you have had the Hepatitis B virus in your body for a long time, usually more than six months. It can affect your liver and may need ongoing monitoring.

What are 'biomarkers'?

Biomarkers are simply things in your body, like certain substances in your blood, that doctors can measure. They can provide clues about your health or how a disease is progressing.

Will taking part in this study change my current Hepatitis B treatment?

No, this study is about observing and learning from new blood tests. It will not change the standard treatment plan your doctor has for you.

How much extra blood will be taken?

You would have about 18ml of extra blood taken once a year during your regular check-ups. This is a small amount, roughly a tablespoon and a half.

What happens if I decide I don't want to be in the study anymore?

You are free to leave the study at any time, for any reason, without it affecting your medical care.

How to find out more

Vincent LEROY, Dr

vincent.leroy2@aphp.fr +33 0149812325 Official trial record

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