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Long-term follow-up for hepatitis B treatment response durability

A Prospective, Multi-Centre Study (B-Sure) to Evaluate Long-Term Durability of Treatment Response in Chronic Hepatitis B Participants With and Without Nucleos(t)Ide Therapy Who Have Participated in a Previous Bepirovirsen Treatment Study

Phase 2 Interventional GlaxoSmithKline · NCT04954859

This study looks at how well hepatitis B treatment works over the long term for people who previously responded to a medication called bepirovirsen.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment450 (estimated)
Ages18 Years and up
SexAll
SponsorGlaxoSmithKline Industry-sponsored
Locations51 sites (Sacramento, California and 50 other locations)
Trial IDNCT04954859 on ClinicalTrials.gov

What this trial studies

This global multi-center follow-up study evaluates the long-term durability of treatment response in participants who previously received bepirovirsen for hepatitis B. Eligible participants are those who achieved a complete or partial response in earlier bepirovirsen studies and will be categorized based on their nucleos(t)ide analogue treatment status. The study does not involve further administration of bepirovirsen, focusing instead on monitoring the maintenance of treatment response over time.

Who should consider this trial

Good fit: Ideal candidates are individuals who previously participated in bepirovirsen studies and achieved a significant treatment response.

Not a fit: Patients who have not participated in prior bepirovirsen studies or did not achieve a treatment response will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the long-term effectiveness of bepirovirsen in managing hepatitis B.

How similar studies have performed: Other studies involving bepirovirsen have shown promising results, indicating potential for success in this follow-up approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion criteria:

* 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.

For participants rolling over from 209668 (B-Clear), 209348 (B-Together), and 212602 (B-Fine):

* Participants who have previously received at least one dose of bepirovirsen AND

  1. Achieved the PSPO in the parent study and who maintained a response until the End of Study (EoS) visit in their parent study (defined as complete responders to bepirovirsen from the parent study) OR
  2. Demonstrated hepatitis B virus surface antigen (HBsAg) reduction greater than or equal to (≥) 1.0 log10 international units per milliliter (IU/mL) from parent study Baseline with HBsAg levels less than (\<) 100 IU/mL and HBV deoxyribonucleic acid (DNA) \< lower limit of quantification (LLOQ) for 24 weeks after the actual end of treatment regimen, in the absence of rescue medication and maintained until their EoS visit in the parent study.

For participants rolling over from 202009 (B-Well1) and 219288 (B-Well 2):

* Participants who have previously received at least 1 dose of bepirovirsen (or matching placebo where appropriate) AND

  1. NA cessated at Week 48 in parent study and achieved at least HBsAg \<1 IU/ml and HBV DNA \<LLOQ at the EOS visit (Week 96) in the parent study OR
  2. Achieved NA cessation criteria at Week 48 in parent study but have not stopped NA treatment, and are maintaining at least HBsAg \<1 IU/ml and HBV DNA \<LLOQ at EOS visit (Week 72) of parent study OR
  3. Did not achieve NA cessation criteria in parent study but achieved at least HBsAg \<1 IU/ml and HBV DNA \<LLOQ at EOS visit (Week 72) of parent study.

For participants rolling over from 217023 (TH HBV ASO-001):

* Participants who have previously received at least 1 dose of bepirovirsen AND

  1. Achieved HBsAg \<1 IU/ml and HBV DNA \<LLOQ in parent study at Week 66 (ASO12 arm) or Week 78 (ASO 24 arm) and are maintaining HBsAg \< 1 IU/ml and HBV DNA \<LLOQ, at the EOS study visit \[Week 133 ASO12 arm), or Week 145 (ASO24 arm)\] in parent study OR
  2. Did not achieve HBsAg \<1 IU/ml and HBV DNA \<LLOQ in parent study at Week 66 (ASO12 arm) or Week 78 (ASO24 arm) but have achieved HBsAg \< 1 IU/ml and HBV DNA \< LLOQ by the EOS visit (Week 133 (ASO12 arm) or Week 145 (ASO24 arm)) in the parent study.

Exclusion Criteria:

* 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.

Where this trial is running

Sacramento, California and 50 other locations

+1 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hepatitis BBepirovirsenB-SureNucleosideDurabilityHBsAgFunctional cure
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.