Bepirovirsen Liver Biopsy Study

NCT07696520 | Not Yet Recruiting Phase 2

• 1 other identifier: 2025-1414
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

HEPATITIS B CHRONIC; Hepatitis B Chronic Infection

Keywords

hepatitis B; Bepirovirsen; Liver Biopsy

Outcome Measures

Primary Outcomes (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

  72 weeks

Secondary Outcomes (4)

• Changes in intrahepatic virology

  Up to week 72

• Changes in Intrahepatic immunology

  Up to week 72

• Changes in blood biomarkers

  Up to week 72

• Safety measurements including adverse events (AEs) and serious adverse events (SAEs)

  Up to week 72

Study Arms (2)

Participants on Nucleoside Analogue treatment

EXPERIMENTAL

Participants 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)

Drug: Bepirovirsen; Procedure: Liver biopsy; Procedure: Optional Liver biopsy

Participants not on Nucleoside Analogue treatment

EXPERIMENTAL

Participants not on NA treatment at screening will go through the following stages * 1st Liver Biopsy * 2nd Liver Biopsy during therapy * 3rd Liver Biopsy (optional)

Drug: Bepirovirsen; Procedure: Liver biopsy; Procedure: Optional Liver biopsy

Interventions

Bepirovirsen DRUG

Weekly Bepirovirsen treatment for 24 weeks, with loading doses

Participants not on Nucleoside Analogue treatment; Participants on Nucleoside Analogue treatment

Liver biopsy PROCEDURE

Liver biopsy as previously described

Participants not on Nucleoside Analogue treatment; Participants on Nucleoside Analogue treatment

Optional Liver biopsy PROCEDURE

An optional Liver biopsy as previously described

Participants not on Nucleoside Analogue treatment; Participants on Nucleoside Analogue treatment

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• A*Star: collaborator
• National University of Singapore: collaborator
• National University Health System, Singapore: lead

Study Sites (1)

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

Singapore, 119074, Singapore

Location

MeSH Terms

Conditions

Hepatitis B, Chronic; Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Seng Gee Prof Lim, Professor

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seng Gee Prof Lim, Professor

CONTACT

+6567724369; mdclimsg@nus.edu.sg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 10, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: July 10, 2026

Record last verified: 2026-07

Locations

SG (1)