NCT07908459Not yet recruitingPhase 4
B-Ensure: Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants
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
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 303 (estimated)
- First submitted
- 26 Oct 2026
- Start date
- 3 Dec 2026
- Primary completion date
- 3 Dec 2030
- Lead sponsor
- GlaxoSmithKline
- Diseases
- Hepatitis B
- NCT number
- NCT07908459
- EudraCT number
- 2026-528519-28
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 303
- From 3 Dec 2026 to the primary completion date, 3 Dec 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Any condition which, in the opinion of the investigator or Medical Monitor, contraindicates their participation in this study.
Who the study is looking for
- 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).
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.