Bepirovirsen Liver Biopsy Study (NCT07696520) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Bepirovirsen Liver Biopsy Study
Singapore30 participantsStarted 2026-07-01
Plain-language summary
Bepirovirsen Liver Biopsy study is a single centre open label phase II study to examine the antiviral and immunological effects of bepirovirsen in CHB patients both treated and untreated with HBsAg\<1000 IU/ml
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. At least 21 years of age at the time of signing the informed consent.
. Documented to be HBsAg positive for ≥ 6 months prior to Screening.
. Currently receiving stable NA therapy (defined as no changes to their NA regimen from at least 6 months prior to Screening and with no planned changes to the stable regimen over the duration of the study), or not receiving any Hepatitis B treatment for at least 6 months, or Hepatitis B treatment naïve.
. qHBsAg ≤1000 IU/ml
. Alanine aminotransferase (ALT) ≤2x ULN
. A female participant is eligible to participate if she is not pregnant or breastfeeding, and 1 of the following conditions applies:
. Capable of giving signed informed consent
Exclusion criteria
. qHBsAg \> 1000 IU/ml
. Do not consent to participate in the Bepirovirsen Liver Biopsy study
. Clinically significant abnormalities or clinically significant physical examination findings (e.g. major surgery within 3 months of screening)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Functional cure rate after 24 weeks of weekly Bepirovirsen therapy at the end of the study at 72 weeks and 60 weeks for participants on NA therapy and not on NA therapy respectively.
Timeframe: 72 weeks
Trial details
NCT IDNCT07696520
SponsorNational University Health System, Singapore
. Past history of or current co-infection with Hepatitis C infection, Human immunodeficiency virus (HIV) or Hepatitis D virus
. History of or liver cirrhosis as determined by:
. Fibroscan \> 12kPa
. Participant's historic record of either/both liver biopsy or liver stiffness measurements in their medical records where their results are Liver biopsy Metavir Score is F4, they will be excluded from the study(If the participant has inconsistent clinical picture of cirrhosis, confirm and discuss eligibility with an investigator)
. Diagnosed with hepatocellular carcinoma as evidenced by Alpha-fetoprotein concentration ≥200 ng/mL or if the screening alpha fetoprotein concentration is ≥50 ng/mL and \<200 ng/mL, the absence of liver mass must be documented by imaging within 6 months of or at screening. Cases should be discussed with an investigator.