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Long-Term Follow-up Study for Subjects With CHB Previously Treated With Imdusiran (AB729)

This study is for people in the UK who have chronic hepatitis B and previously participated in a clinical trial using the medication imdusiran (AB729). Participants must have stopped their regular hepatitis B treatment (NA therapy) during that earlier trial and still be off it. This is a "follow-up" study, meaning no new treatments will be given. Instead, researchers will check your health over approximately two years by taking blood samples, noting any medicines you currently take, and recording any side effects. The goal is to understand what happens to people's health in the long term after stopping imdusiran treatment.

At a glance

Status
Recruiting
Sponsor
Arbutus Biopharma Corporation
Enrolment target
50
Start
11 Jul 2024
Estimated completion
30 Oct 2029

What is this study about?

This study is designed for adults in the UK who have chronic hepatitis B (CHB) and have previously taken part in a clinical trial where they received a medicine called imdusiran (also known as AB729). The main purpose is to carefully watch how people are doing over a longer period after they have stopped taking their hepatitis B medication (called NA therapy) as part of the earlier imdusiran trial.

Think of this as checking in on your health after your previous treatment. The researchers want to understand the long-term effects and how your body manages without ongoing medication. This kind of study is important because it helps doctors learn more about chronic hepatitis B and how new treatments like imdusiran might help people in the real world after their initial treatment finishes.

It’s important to know that this isn't a treatment study itself. You won't be given any new medications or active treatments as part of this follow-up. Instead, the focus is purely on observing your health without any new interventions, which helps gather valuable information for future patients.

Key takeaways

  • This study is for people who were in a previous imdusiran trial for chronic hepatitis B.
  • It's a follow-up study, meaning no new treatments are given.
  • The main activities are blood tests and health check-ups.
  • Participation will last for about two years.
  • It aims to understand long-term health after stopping treatment.

Who may be eligible?

This study is looking for adults aged between 20 and 70, men and women, who have chronic hepatitis B.

To join, you must have previously participated in another clinical trial where you received the medicine imdusiran. Crucially, you must have stopped your regular hepatitis B medication (called NA therapy) during that previous trial, and you need to still be off that medication when you join this particular study.

Finally, you need to be able to understand the study details and give your written permission to take part. You should also be able to stick to the planned schedule of visits and requirements.

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 between 20 and 70 years old?
  2. Have you participated in a previous imdusiran clinical trial?
  3. Did you stop your regular hepatitis B medication (NA therapy) during that trial?
  4. Are you still off your regular hepatitis B medication now?
  5. Are you able to understand and sign consent forms and attend study visits?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be in the study for about two years. During this time, you won't be given any new experimental treatments or medications. Your involvement will mainly include occasional short visits where a small blood sample will be taken. The study team will also ask you about any other medicines you are currently taking and check for any health issues or side effects you might experience, especially if you happen to restart your regular hepatitis B treatment. The goal is to ensure that, including your time in the previous imdusiran study, you will have been followed for at least three years since stopping your regular hepatitis B medication.

Potential risks and benefits

Taking part in this study could help doctors learn more about the long-term effects of imdusiran for people with chronic hepatitis B, which could benefit future patients. The risks in this study are generally low, mainly involving the minor discomfort of blood samples and the time commitment for appointments. There's also a chance that if your hepatitis B comes back, you might need to restart your regular medication. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (18)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Research and Education Inc.
    Verified postcode
    San Diego, United States· Recruiting
  • University of Miami Miller School of Medicine
    Verified postcode
    Miami, United States· Not yet recruiting
  • Infectious Disease Care
    Verified postcode
    Hillsborough, United States· Recruiting
  • The Alfred Hospital
    Verified postcode
    Melbourne, Australia· Recruiting
  • Fiona Stanley Hospital
    Verified postcode
    Murdoch, Australia· Not yet recruiting
  • Prince of Wales Hospital
    Verified postcode
    Shatin, Hong Kong· Recruiting
  • Queen Mary Hospital
    Verified postcode
    Hong Kong, Hong Kong· Recruiting
  • Arensia Exploratory Medicine Moldova
    Verified postcode
    Chisinau, Moldova· Recruiting
  • Asan Medial Center
    Verified postcode
    Seoul, South Korea· Not yet recruiting
  • Changhua Christian Hospital
    Verified postcode
    Changhua, Taiwan· Recruiting
  • Chia-Yi Christian Hospital
    Verified postcode
    Chiayi City, Taiwan· Recruiting
  • Kaohsiung Medical University Chung-Ho Memorial Hospital
    Verified postcode
    Kaohsiung City, Taiwan· Recruiting

Common questions

What is chronic hepatitis B?

Chronic hepatitis B is a long-lasting liver infection caused by the hepatitis B virus.

What is Imdusiran (AB729)?

Imdusiran (AB729) is a medicine that was being tested in previous trials for people with chronic hepatitis B.

Will I receive any new medicine in this study?

No, this is a follow-up study, so you will not receive any new medicines or treatments.

How long will I be in the study?

You will be in this study for about two years.

What will I have to do if I join?

You will have blood tests, answer questions about your current medicines, and report any health problems or side effects.

How to find out more

Michael Child

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

Interested in taking part?

Register your interest

Share your details and the research team for "Long-Term Follow-up Study for Subjects With CHB Previously T…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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