Hepatitis B immunoglobulins to induce HBsAg clearance in patients with chronic hepatitis B (HBIG for cure)
This study is investigating a new treatment approach for people with long-term hepatitis B. It involves giving patients certain antibodies, called immunoglobulins (like Hepatect CP or Zutectra), which are thought to help their bodies fight off the hepatitis B virus more effectively. The main goal is to find out if this treatment can make the hepatitis B surface antigen (a sign of the virus) disappear from the blood within 12 weeks while they are also receiving their usual antiviral medicine. Researchers will also be checking if the treatment reduces the amount of virus in the blood, helps liver function improve, and how it affects patients' overall quality of life. This is an early-stage study (Phase II) to see if this new treatment works and is safe.
At a glance
What is this study about?
This research is looking into a new way to help people who have chronic hepatitis B. Chronic hepatitis B means the hepatitis B virus has been in your body for a long time, and it can cause liver problems. Currently, treatments can keep the virus under control, but they don't always get rid of it completely.
This study is testing if a special type of medicine, called 'immunoglobulins,' can help the body clear the virus. Immunoglobulins are antibodies, which are natural defenders in your immune system. In this study, they are given as an infusion (like a drip) or an injection. The idea is that these extra antibodies might boost your body's ability to get rid of the hepatitis B virus, specifically looking to see if a key marker of the virus, called HBsAg, disappears from your blood.
The main aim of the study is to see if taking these immunoglobulins, alongside your usual anti-viral medication, can make the HBsAg disappear from your blood within 12 weeks. Researchers will also look at how quickly the virus levels change, how your liver is working, and if your general health and wellbeing (quality of life) improve. This is an exploratory study, meaning it's an early step to understand if this new treatment method works well and is safe before it can be offered more widely.
Key takeaways
- This study explores a new treatment for chronic hepatitis B using special antibodies (immunoglobulins).
- The main goal is to see if these antibodies can help clear the hepatitis B virus from the blood.
- It's an early-stage (Phase II) research to check for effectiveness and safety.
- Participants will receive the study treatment in addition to their current antiviral medication.
- Regular blood tests and quality of life checks will be part of the study.
- The study involves 12 weeks of treatment and up to 24 weeks of follow-up.
Who may be eligible?
To be considered for this study, you need to be an adult, 18 years old or older. The study is open to both men and women.
However, having chronic hepatitis B is a must. This means you have been living with the hepatitis B virus for a long time. There will be other specific medical details relating to your hepatitis B and general health that the study doctors will need to check to make sure the study is a good fit for you and safe for you to take part.
It's important to discuss your full medical history with the study team. They will review all your health information to confirm if you meet all the necessary requirements to join this research.
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 chronic hepatitis B?
- Are you currently receiving antiviral therapy for hepatitis B?
- Are you able to attend regular clinic appointments and blood tests?
What does participation involve?
If you join this study, you would receive the study medication, either Hepatect CP or Zutectra, which are special antibody treatments given alongside your existing antiviral therapy. These will be given as infusions or injections.
Throughout the study, you will have regular visits to the clinic. These visits will involve blood tests to check your hepatitis B virus levels (HBsAg and HBV DNA), your liver function (ALT levels), and your overall health. You will also be asked to fill out questionnaires to assess your quality of life (using something called an SF-36 questionnaire).
The main treatment period will last 12 weeks. However, the study will continue to follow your health and virus levels for up to 24 weeks after your treatment finishes to see how you are doing in the longer term. Your study team will explain the exact schedule of visits and assessments.
Potential risks and benefits
Locations (1)
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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, which can lead to liver damage over time.
What are immunoglobulins?
Immunoglobulins are special antibodies, which are proteins your body uses to fight off infections. In this study, they are given as a medicine to help fight the hepatitis B virus.
What does 'HBsAg negativity' mean?
HBsAg negativity means that a specific marker for the hepatitis B virus has disappeared from your blood, which is a sign that the virus may be clearing from your body.
Will I still take my regular hepatitis B medicine?
Yes, this study involves taking the new immunoglobulin treatment alongside your existing antiviral therapy for hepatitis B.
How long will I be involved in the study?
The main treatment lasts 12 weeks, but you will be followed up for your health and virus levels for up to 24 weeks after treatment finishes.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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