Last updated: 10/26/2026 17:42:32

B-Ensure: Long-term follow-up study to evaluate durability of treatment response in previous bepirovirsen study participantsB-Ensure

GSK study ID
317556
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
2026-528519-28
Trial status
Not yet recruiting
Not yet recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: B-Ensure: A multi-centre, prospective and retrospective study to evaluate the long-term durability of treatment response in participants with chronic hepatitis B who have participated in a previous bepirovirsen treatment study
Trial description: This multi-country, longitudinal follow-up study will enrol adults with chronic hepatitis B (CHB) who previously participated in the Phase III B-Well-1 ((202009: NCT05630807) or B-Well-2 (219288: NCT05630820) studies, received 24 weeks of Bepirovirsen treatment, and achieved hepatitis B surface antigen (HBsAg) levels less than or equal to (<=) 100 International units per millilitres (IU/mL) at Week 72 without achieving functional cure. No investigational treatment will be administered in this study. Participants will be followed approximately every 6 months for up to 4 years, and retrospective data will be collected from Week 72 of the parent study until enrolment. The study aims to evaluate the long-term durability of HBsAg suppression and disease-related outcomes. The study will end at the last visit of the last participant globally (Month 48). The primary objective of the study is to describe the long-term durability of HBsAg reduction in participants who achieved HBsAg levels ≤100 IU/mL at Week 72 following 24 weeks of Bepirovirsen treatment.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:

Time From B-Well Week 72 to Confirmed Loss of Response

Timeframe: From B-Well Week 72 assessment up to Month 48

Secondary outcomes:

Absolute HBsAg Value at Each Follow-up Assessment

Timeframe: From B-Well Week 72 assessment up to Month 48

Change From Week 72 in HBsAg Level at Each Follow-up Assessment

Timeframe: From B-Well Week 72 assessment up to Month 48

Proportion of Participants Maintaining or Achieving Predefined HBsAg Thresholds

Timeframe: From B-Well Week 72 assessment up to Month 48

Proportion of Participants Who Achieve Functional Cure

Timeframe: From B-Well Week 72 assessment up to Month 48

Number of Participants with Clinical Relapse

Timeframe: From B-Well Week 72 assessment up to Month 48

Change From Week 72 Baseline in Hepatitis B Quality of Life Questionnaire (HBQoL) Score

Timeframe: From B-Well Week 72 assessment up to Month 48

Number of Participants with Healthcare Resource Utilization (HCRU)

Timeframe: From B-Well Week 72 assessment up to Month 48

Number of Participants with Hepatic Disease Progression Outcomes

Timeframe: From B-Well Week 72 assessment up to Month 48

Interventions:
Drug: Bepirovirsen
Enrollment:
303
Primary completion date:
2030-03-12
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Hepatitis B
Product
Bepirovirsen
Collaborators
Not applicable
Study date(s)
December 2026 to December 2030
Type
Interventional
Phase
4

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Participants who received bepirovirsen and completed the Week 72 visit (or had a last available observation) in the B-Well trials.
  • Had HBsAg <=100 IU/mL at Week 72 of the B-Well trials.
  • Participants who, at the time of enrollment into this study, are participating in another interventional clinical study evaluating treatment for HBV, or who have participated in such a study after completing treatment with bepirovirsen and prior to enrollment in this study.
  • Any condition which, in the opinion of the investigator or Medical Monitor, contraindicates their participation in this study.
Inclusion and exclusion criteria
Inclusion criteria:

    Participants who received bepirovirsen and completed the Week 72 visit (or had a last available observation) in the B-Well trials.

    • Had HBsAg <=100 IU/mL at Week 72 of the B-Well trials.
    • Were not enrolled in the B-Sure study.
    • Provide informed consent and are willing to participate in long-term follow-up (B-Ensure).
Exclusion criteria:

    Participants who, at the time of enrollment into this study, are participating in another interventional clinical study evaluating treatment for HBV, or who have participated in such a study after completing treatment with bepirovirsen and prior to enrollment in this study.

    • Any condition which, in the opinion of the investigator or Medical Monitor, contraindicates their participation in this study.

Trial location(s)

No location data available.

Study documents

No study documents available.

Results overview

Study Results yet to be posted

Recruitment status
Not yet recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

Additional information
Not applicable
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