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HEPATITIS B CHRONICPhase 2GSK BiopsyNCT07696520

Bepirovirsen Liver Biopsy Study

A Phase 2 study testing Bepirovirsen, Liver biopsy and Optional Liver biopsy in people with HEPATITIS B CHRONIC and Hepatitis B Chronic Infection, run by National University Health System, Singapore at 1 site in Singapore.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 21 years and older
What is being tested?
Bepirovirsen, Liver biopsy and Optional Liver biopsy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteSingapore
Study dates
1 Jul 2026to 30 Apr 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • Is a woman of non-childbearing potential
  • Is a woman of childbearing potential and using a contraceptive method
  • Capable of giving signed informed consent

Who cannot join

  • 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)
  • 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
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  • 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.
  • History of malignancy within the past 5 years with the exception of specific cancers that are cured by surgical resection (e.g., skin cancer). Participants under evaluation for possible malignancy are not eligible.
  • History of vasculitis or presence of symptoms and signs of potential vasculitis, current or history of an autoimmune condition or history/presence of other diseases that may be associated with vasculitis condition
  • History of extrahepatic disorders possibly related to HBV immune conditions
  • Current/History of alcohol or drug abuse/dependence as judged by the investigator to potentially interfere with participant compliance
  • Currently taking, or took within 3 months of screening, any immunosuppressing drugs, other than a short course of therapy (≤2 weeks) or topical/inhaled steroid use.
  • Participants requiring anti-coagulation therapies or anti-platelet agents unless treatment can safely be discontinued throughout duration of Bepirovirsen treatment, by the discretion of the investigator. Occasional use is permitted.
  • The participant has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 5 half-lives (if known) or twice the duration (if known) of the biological effect of the study treatment (whichever is longer) or 90 days (if half-life or duration is unknown).
  • Prior treatment with any oligonucleotide or siRNA within 12 months prior to the first dosing day
  • Prior treatment with Bepirovirsen within 6 months
  • Fridericia's QT correction formula (QTcF) ≥450 msec (if single ECG at screening shows QTcF ≤450 msec, a mean of triplicate measurements should be used to confirm that participant meets exclusion criterion).
  • Laboratory results as follows:
  • Serum albumin ≤3.5 g/dL
  • Glomerular filtration rate (GFR) ≤60 mL/min/1.73m2 as calculated by the CKD-EPI formula
  • INR >1.25
  • Platelet count <140 x 109/L
  • Total bilirubin >1.25x ULN (For participants with benign unconjugated hyperbilirubinemia with total bilirubin >1.25x ULN, discussion for inclusion to the study is required with the investigator)
  • Urine albumin to creatinine ratio (uACR) >0.3 mg/mg (or >300 mg/g). (In the event of an uACR above this threshold, eligibility may be confirmed by a second measurement. In cases where results are shown as unable to perform (UTP), please check the individual labs and confirm that the participant has urine albumin and/or urine creatinine within normal levels. The investigator should confirm that the participant does not have a history of medical conditions or other risk factors that may affect renal function)
  • History of/sensitivity to Bepirovirsen or components thereof or a history of drug or other allergy that, in the opinion of the investigator, contraindicates their participation.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Seng Gee Prof Lim, Professor contact

+6567724369

mdclimsg@nus.edu.sg

Singapore1 site

  • Division of Gastroenterology & Hepatology, National University Hospital (NUH)

    Singapore, 119074

    Seng Gee Prof Lim, Professor, +6567724369, mdclim@nus.edu.sg

    Seng Gee Prof Lim, Professor

Other trials in Singapore

About this study

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

Read the detailed description

HYPOTHESIS AND OBJECTIVES Bepirovirsen, an ASO, has shown 19% Functional Cure rates in a phase 3 clinical trial but its intrahepatic mechanism of action is unclear, possibly through immune mechanisms since animal studies show a significant proportion of Bepirovirsen accumulates in non-parenchymal cells of the liver. Investigating the immunological and virological intrahepatic microenvironment before and during Bepirovirsen therapy will lead to insights into the mechanism of HBsAg loss, and differentiate sustained responders from transient responders.

Study Aims

  1. Determine the functional cure rate in Chronic Hepatitis B (CHB) patients with qHBsAg ≤1000 IU/ml treated with Bepirovirsen weekly for 24 weeks at the end of the study at 72 weeks and 60 weeks for patients on NA therapy and not on NA therapy respectively
  2. Determine the immunological and virological effects of Bepirovirsen in the intrahepatic microenvironment using paired liver biopsies

Primary Objective 1. Proportion of patients with functional cure in CHB patients who have qHBsAg ≤1000 IU/ml treated with Bepirovirsen

Secondary Objectives

  1. Determine intrahepatic immune cell types and pathways activated by Bepirovirsen
Being tested
Bepirovirsen, Liver biopsy, Optional Liver biopsy
Keywords
hepatitis B, Bepirovirsen, Liver Biopsy
Medical subject headings
Hepatitis B, Chronic, Hepatitis B

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BepirovirsenDrug

    Weekly Bepirovirsen treatment for 24 weeks, with loading doses

  • Liver biopsyProcedure or surgery

    Liver biopsy as previously described

  • Optional Liver biopsyProcedure or surgery

    An optional Liver biopsy as previously described

Study groups in NCT07696520
Study groupRoleWhat they receive
Participants on Nucleoside Analogue treatmentExperimentalParticipants on NA treatment at screening will go through the following stages: * 1st Liver Biopsy at baseline * 2nd Liver Biopsy during therapy * 3rd Liver Biopsy (optional)
Receives: Drug: Bepirovirsen; Procedure: Liver biopsy; Procedure: Optional Liver biopsy
Participants not on Nucleoside Analogue treatmentExperimentalParticipants not on NA treatment at screening will go through the following stages * 1st Liver Biopsy * 2nd Liver Biopsy during therapy * 3rd Liver Biopsy (optional)
Receives: Drug: Bepirovirsen; Procedure: Liver biopsy; Procedure: Optional Liver biopsy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Functional cure defined as HBsAg<0.05 IU/ml and HBV DNA <LLOQ 24 weeks off all therapy

    Measured: 72 weeks

Secondary outcomes (4)

  1. Changes in intrahepatic virology

    The changes of liver HBsAg, HBcAg, HBV RNA, integration HBV DNA and covalently closed circular DNA (cccDNA) compared to baseline;

    Measured: Up to week 72

  2. Changes in Intrahepatic immunology

    The changes in the liver immune cells compared to baseline

    Measured: Up to week 72

  3. Changes in blood biomarkers

    The changes of serum HBsAg, HBsAb, HBV DNA, HBV RNA, HBcrAg, HBsAg isoforrms, ultrasensitive HBsAg compared to baseline; changes in immune cell phenotypes, blood cytokines compared to baseline

    Measured: Up to week 72

  4. Safety measurements including adverse events (AEs) and serious adverse events (SAEs)

    Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAE) and clinically significant adverse events of interest

    Measured: Up to week 72

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2026
  2. Study start1 Jul 2026 (estimated)
  3. Primary completion30 Dec 2027 (estimated)
  4. Study completion30 Apr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07696520
Sponsor's protocol ID
2025-1414
Acronym
GSK Biopsy
Status last verified
Jul 2026
First submitted
6 Jul 2026
Last updated
10 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bepirovirsen, Liver biopsy and Optional Liver biopsy in people with HEPATITIS B CHRONIC and Hepatitis B Chronic Infection, run by National University Health System, Singapore at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Seng Gee Prof Lim, Professor (+6567724369, mdclimsg@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 72 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07696520.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.

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