Active not recruitingOBSERVATIONAL

HBRN: Immune Regulation and Costimulation in Natural History of Chronic Hepatitis B

This study, linked to a larger research project on hepatitis B, aims to understand how the body's immune system behaves in people with long-term hepatitis B. Researchers are particularly interested in the balance between two types of immune responses: those that regulate or calm down the immune system, and those that actively fight the virus. By looking at blood tests and liver health, they hope to get a clearer picture of why hepatitis B affects people differently. They also want to see how this balance changes when people experience a short worsening of their hepatitis, known as a flare. This research could help us better understand the disease and potentially lead to new ways of managing it in the future.

At a glance

Status

Active not recruiting

Sponsor

University of Pennsylvania

Enrolment target

201

Start

01 Feb 2011

Estimated completion

01 Dec 2026

Hepatitis B

What is this study about?

This study is about understanding how your body's amazing defence system, called the immune system, works in people who have long-term hepatitis B. Hepatitis B is a virus that can cause liver problems, and for some people, it stays in their body for many years.

Researchers want to carefully look at the different parts of your immune system. They're particularly interested in finding out if there's a certain way the immune system acts that makes some people with hepatitis B have more liver problems or higher levels of the virus, while others don't. They also want to see how these immune system actions are linked to things like how much of the virus is in the blood, how well the liver is working (measured by something called ALT), and even what the liver looks like under a microscope.

They also plan to investigate what happens to this immune balance when someone with long-term hepatitis B experiences a sudden worsening of their condition, which doctors call a 'flare.' By gathering all this information, the study aims to build a clearer picture of how hepatitis B affects the body and why it behaves differently in various people. This understanding is really important because it could eventually help doctors find better ways to help people living with hepatitis B.

Key takeaways

Study looks at immune system balance in long-term hepatitis B.
Aims to understand why hepatitis B affects people differently.
No new medicines or extra tests are involved.
Uses existing blood samples from a larger hepatitis B study.
Helps advance understanding of hepatitis B.
Open to adults aged 18 and over.

Who may be eligible?

To be part of this study, you need to be an adult, aged 18 or older, and be willing to give your permission to take part. This study is open to both men and women.

However, there are some reasons why you might not be able to join. For example, if you have certain health conditions like severe anaemia (very low iron in your blood), serious heart or lung problems that need oxygen, serious kidney problems, or if you have another significant illness. People with autoimmune diseases (where your body attacks itself) or those taking medicines that weaken the immune system are also not able to join.

Essentially, the study is looking for adults with hepatitis B who are generally healthy apart from their hepatitis, to make sure the results clearly show how hepatitis B affects the immune system without other major health issues clouding the picture.

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?
Do you have chronic (long-term) hepatitis B?
Are you currently participating in the main HBRN Study Cohort Study (NCT01263587)?
Do you have any serious heart, lung, or kidney problems?
Do you have severe anaemia (very low blood count)?
Do you have an autoimmune disease or take medicines to suppress your immune system?

Answer every question to see your result.

What does participation involve?

This study is an add-on part of a larger ongoing study about hepatitis B. If you are already participating in that main study (NCT01263587), you would be asked if you'd like to take part in this additional research.

Taking part would involve agreeing to have your blood samples looked at more closely than usual. These samples would come from blood tests you already have as part of the main study. There are no extra hospital visits or additional medications specifically for this study. The researchers will be using information collected from your routine check-ups and existing blood tests to understand your immune system. The overall duration would depend on how long you are part of the main Hepatitis B Research Network study.

Potential risks and benefits

There are no major additional risks to you from taking part in this specific study, as it primarily involves using existing blood samples and information from your routine care in the main study. This means you won't need extra blood tests just for this. The potential benefit is that your contribution will help researchers better understand how hepatitis B affects the immune system, which could eventually lead to improved treatments for people with this condition. You are free to decide whether to take part, and you can withdraw your permission at any time without it affecting your care in the main study.

Locations (12)

California Pacific Medical Center
Verified postcode
San Francisco, United States
University of California San Francisco Medical Center
Verified postcode
San Francisco, United States
Massachusetts General Hospital
Verified postcode
Boston, United States
Beth Israel Deaconess Medical Center
Verified postcode
Boston, United States
University of Minnesota
Verified postcode
Plymouth, United States
Mayo Clinic Rochester
Verified postcode
Rochester, United States
University of North Carolina
Verified postcode
Chapel Hill, United States
University of Texas Southwestern
Verified postcode
Dallas, United States
Virginia Commonwealth University
Verified postcode
Richmond, United States
Virginia Mason Medical Center
Verified postcode
Seattle, United States
Harborview Medical Center
Verified postcode
Seattle, United States
University of Toronto
Verified postcode
Toronto, Canada

Common questions

What is the main goal of this study?

The main goal is to understand how your body's immune system works in people with long-term hepatitis B, especially how different parts of the immune system balance each other out.

Will I have to take new medicines?

No, this study does not involve taking any new medicines. It focuses on studying blood samples and information already collected from you as part of another hepatitis B study.

Will I need extra blood tests?

No, you won't need extra blood tests specifically for this study. Researchers will use blood samples that you already have taken during your regular checks in the main study you are part of.

Who is funding this research?

This study is linked to a larger project sponsored by the NIDDK, a part of the US National Institutes of Health, but it's important to know this is a research study and not a medical service.

If I join, does it affect my regular medical care?

No, joining or not joining this study will not affect the medical care you receive for your hepatitis B. You can also change your mind and withdraw at any time.