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Long-term Follow-up for Bepirovirsen in Hepatitis B (B-Sure)

This study, called B-Sure, is for people who previously participated in a bepirovirsen study for Hepatitis B and had a good response to treatment. It aims to see how long the positive effects of bepirovirsen last. You won't receive any new bepirovirsen or placebo in this study. Instead, researchers will follow your health over time to check if your treatment response from the earlier study is maintained. This study is for adults aged 18 and older who are able to give informed consent. Success in this study means maintaining the treatment response you achieved in the original bepirovirsen study. The current status of this study is unclear.

Study design
This is an interventional, long-term follow-up study with a planned enrollment of 360 participants. It includes individuals who previously received bepirovirsen or placebo in related studies.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 57 months, depending on their original study and treatment status.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04954859

Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)

Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatment
GlaxoSmithKline
~360 participants
Updated 2026-06-24 on ClinicalTrials.gov
What's tested:BepirovirsenPlacebo

At a glance

Recruiting sites
0 of 163 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Not-on-NA participants without loss of parent study primary outcome (PSPO)
Measured over From primary endpoint assessment in the parent study up to Month 57
+3 more outcomes measured

Conditions

Hepatitis B

Explore related trials

Hepatitis B InfectionHepatitis B InfectionHepatitis B Virus HBsAg Surface Protein Antigen

Where it's being run

163 sites across 39 states
China25
Japan16
India10
Taiwan8
Italy7
Russia7
Bulgaria6
France6

Study leadership

  • GSK Clinical Trials · STUDY_DIRECTOR · GlaxoSmithKline

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participants who enter the study on stable NA are willing and able to cease their NA treatment in accordance with the NA cessation schedule.
Capable of giving informed consent.
Participants who have previously received at least one dose of bepirovirsen AND
Participants who have previously received at least 1 dose of bepirovirsen (or matching placebo where appropriate) AND
Participants who have previously received at least 1 dose of bepirovirsen AND

Exclusion

Participants who have/or are currently participating in another non-GSK interventional clinical study exploring HBV treatment since completing their treatment with bepirovirsen.
Any condition which, in the opinion of the investigator or Medical Monitor, contraindicates their participation in this study.

What this trial measures

  • Percentage of Not-on-NA participants without loss of parent study primary outcome (PSPO)From primary endpoint assessment in the parent study up to Month 57

    NA indicates nucleos(t)ide analogue (NA).

  • Percentage of On-NA participants rolling over from studies 209668 and 209348 without loss of functional cure (FC) after NA-cessation in study 206882From Month 3 up to Month 57
  • Percentage of On-NA participants rolling over from study 217023 without loss of FC after NA-cessation in study 206882From Month 3 up to Month 33
  • Percentage of NA-cessated participants rolling over from studies 202009 and 219288 without loss of FC after NA-cessation in the parent studyFrom primary endpoint assessment in the parent study up to Month 33