Hepatitis BPhase 4B-EnsureNCT07908459
B-Ensure: Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants
A Phase 4 study testing Bepirovirsen in people with Hepatitis B, run by GlaxoSmithKline.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Bepirovirsen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 303 participants
- Where
- No sites listed yet
- Study dates
- 3 Dec 2026to 3 Dec 2030
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Conditions
- Hepatitis B
- Being tested
- Bepirovirsen
- Keywords
- Bepirovirsen, Chronic hepatitis B (CHB), Hepatitis B surface antigen (HBsAg), Hepatitis B virus deoxyribonucleic acid (HBV DNA), Long-term follow-up, Durability of response, Healthcare resource utilization (HCRU), Hepatitis B Quality of Life Questionnaire (HBQoL)
- Medical subject headings
- Hepatitis B, Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BepirovirsenDrug
No study medication will be administered in this study. Eligible participants who received bepirovirsen in the parent studies will be included.
| Study group | Role | What they receive |
|---|---|---|
| Participants Who Received Bepirovirsen in B-Well | Experimental | Participants who received Bepirovirsen in B-Well studies (202009: NCT05630807) or B-Well-2 (219288: NCT05630820) will be enrolled in the study. No study intervention will be administered in this study. Receives: Drug: Bepirovirsen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time From B-Well Week 72 to Confirmed Loss of Response
Confirmed loss of response is defined as HBsAg greater than (>)100 IU/mL at two consecutive assessments.
Measured: From B-Well Week 72 assessment up to Month 48
Secondary outcomes (8)
Absolute HBsAg Value at Each Follow-up Assessment
Measured: From B-Well Week 72 assessment up to Month 48
Change From Week 72 in HBsAg Level at Each Follow-up Assessment
Measured: From B-Well Week 72 assessment up to Month 48
Proportion of Participants Maintaining or Achieving Predefined HBsAg Thresholds
Thresholds of interest include HBsAg <= 100 IU/mL, HBsAg <= 10 IU/mL, or HBsAg Loss. HBsAg loss is defined as HBsAg less than (<) lower limit of quantification (LLOQ) at 2 sequential visits.
Measured: From B-Well Week 72 assessment up to Month 48
Proportion of Participants Who Achieve Functional Cure
Functional cure is defined as sustained suppression (24 weeks or longer) of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) (<LLOQ) off all HBV treatment and loss of HBsAg (HBsAg < LLOQ at 2 sequential visits) with or without hepatitis B surface antibody (HBsAb) after a finite duration of therapy.
Measured: From B-Well Week 72 assessment up to Month 48
Number of Participants with Clinical Relapse
Clinical relapse is defined as HBsAg >= Lower limit of Quantification (LLOQ) and HBV Deoxyribonucleic Acid (DNA) >2000 IU/mL and Alanine Aminotransferase (ALT) >2x Upper Limit of Normal (ULN) at 2 sequential visits.
Measured: From B-Well Week 72 assessment up to Month 48
Change From Week 72 Baseline in Hepatitis B Quality of Life Questionnaire (HBQoL) Score
HBQoL has been designed to assess quality of life in participants with hepatitis B. It consists of 31 items and 6 domains: psychological well-being, anticipation anxiety, vitality, stigma, transmissibility and vulnerability. Response options range from 1 to 5 with higher scores indicating more severe impact of hepatitis B.
Measured: From B-Well Week 72 assessment up to Month 48
Number of Participants with Healthcare Resource Utilization (HCRU)
HCRU includes hospitalizations, emergency department visits, outpatient visits, specialist consultations, and liver-related interventions
Measured: From B-Well Week 72 assessment up to Month 48
Number of Participants with Hepatic Disease Progression Outcomes
Hepatic disease progression outcomes will include cirrhosis, hepatic decompensation, HCC, liver transplantation, liver-related mortality, all-cause mortality.
Measured: From B-Well Week 72 assessment up to Month 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start3 Dec 2026 (estimated)
- Primary completion3 Dec 2030 (estimated)
- Study completion3 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 303 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07908459
- Sponsor's protocol ID
- 317556
- Other IDs
- 2026-528519-28
- Acronym
- B-Ensure
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07908459
- Acronym / sponsor ID
- B-Ensure / 317556
- Conditions
- Hepatitis B
- Keywords
- Bepirovirsen, Chronic hepatitis B (CHB), Hepatitis B surface antigen (HBsAg), Hepatitis B virus deoxyribonucleic acid (HBV DNA), Long-term follow-up, Durability of response, Healthcare resource utilization (HCRU), Hepatitis B Quality of Life Questionnaire (HBQoL)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 303 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 3 Dec 2026 (estimated)
- Primary completion
- 3 Dec 2030 (estimated)
- Study completion
- 3 Dec 2030 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants Who Received Bepirovirsen in B-Well | Experimental | Drug: BepirovirsenParticipants who received Bepirovirsen in B-Well studies (202009: NCT05630807) or B-Well-2 (219288: NCT05630820) will be enrolled in the study. No study intervention will be administered in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BepirovirsenNo study medication will be administered in this study. Eligible participants who received bepirovirsen in the parent studies will be included. | Drug | Participants Who Received Bepirovirsen in B-Well |
Primary outcome
Time From B-Well Week 72 to Confirmed Loss of Response
Time frame: From B-Well Week 72 assessment up to Month 48
Confirmed loss of response is defined as HBsAg greater than (>)100 IU/mL at two consecutive assessments.
8 secondary outcomes
Absolute HBsAg Value at Each Follow-up Assessment
Time frame: From B-Well Week 72 assessment up to Month 48
Change From Week 72 in HBsAg Level at Each Follow-up Assessment
Time frame: From B-Well Week 72 assessment up to Month 48
Proportion of Participants Maintaining or Achieving Predefined HBsAg Thresholds
Time frame: From B-Well Week 72 assessment up to Month 48
Proportion of Participants Who Achieve Functional Cure
Time frame: From B-Well Week 72 assessment up to Month 48
Number of Participants with Clinical Relapse
Time frame: From B-Well Week 72 assessment up to Month 48
Change From Week 72 Baseline in Hepatitis B Quality of Life Questionnaire (HBQoL) Score
Time frame: From B-Well Week 72 assessment up to Month 48
Number of Participants with Healthcare Resource Utilization (HCRU)
Time frame: From B-Well Week 72 assessment up to Month 48
Number of Participants with Hepatic Disease Progression Outcomes
Time frame: From B-Well Week 72 assessment up to Month 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: Yes. Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
Related trials for Hepatitis B
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A Study to Compare Blood Levels of Bepirovirsen and Safety Using Different Methods of Injecting in Healthy Adult Participants
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Active, not recruitingPhase 1/2
A Clinical Study of HT-101 and/or HT-102 in Patients With Chronic Hepatitis B Virus Infection
Chronic Hepatitis B
Recruiting
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RecruitingObservational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bepirovirsen in people with Hepatitis B, run by GlaxoSmithKline.
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 4 inclusion and 2 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 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time From B-Well Week 72 to Confirmed Loss of Response (time frame: From B-Well Week 72 assessment up to Month 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2026.