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ACTIVE NOT RECRUITINGPhase2

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

Sponsor: GlaxoSmithKline

NCT ID: NCT04954859

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Bepirovirsen (drug), Placebo (drug)
How long the study runs
Study runs about 85 months (dates as stated)
About the drug or intervention
Bepirovirsen — drug: No study drug will be administered in this study. · Placebo — drug: No study drug will be administered in this study.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
360
Started
2021-12-14
Last checked
2026-06

Plain English Summary

What is this study?

  • • Testing a new treatment for hepatitis b
  • • Phase2 - 360 participants
  • • This is a global multi-center, long-term follow-up study to assess durability of efficacy, as measured by maintenance of treatment response from the parent study, in participants who participated in a previous bepirovirsen study and achieved a complete or partial response

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with hepatitis b

Where?

  • • Cottingham - GSK Investigational Site
  • • Liverpool - GSK Investigational Site
  • • London - GSK Investigational Site
  • • London - GSK Investigational Site
  • • +1 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

This is a global multi-center, long-term follow-up study to assess durability of efficacy, as measured by maintenance of treatment response from the parent study, in participants who participated in a previous bepirovirsen study and achieved a complete or partial response. Eligible participants will be enrolled in this study after completing the end of study (EoS) visit in the respective parent bepirovirsen studies (studies B-Clear \[209668: NCT04449029\], B-Together \[209348: NCT04676724\], B-Fine \[212602: NCT04544956\], B-Well 1 \[202009: NCT05630807\], B-Well 2 \[219288: NCT05630820\], and TH HBV ASO-001 \[217023: NCT05276297\]). Participants will be categorized as Not-on-NA, NA-cessated, or On-NA based on their nucleos(t)ide analogue (NA) status in the parent study. No further treatment with bepirovirsen will be administered in this study.

Hepatitis B

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Participants who enter the study on stable NA are willing and able to cease their NA treatment in accordance with...
  • ✓Capable of giving agreement to take part.
  • ✓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
  • ✓Achieved the PSPO in the parent study and who maintained a response until the End of Study (EoS) visit in their...

Who cannot take part

  • ✗Participants who have/or are currently participating in another non-GSK interventional clinical study exploring HBV...
  • ✗Any condition which, in the opinion of the investigator or Medical Monitor, contraindicates their participation in...
See the full 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 Is This Study? (5 UK sites)

GSK Investigational Site

Cottingham HU16 5JQ, United Kingdom

GSK Investigational Site

Liverpool L7 8XP, United Kingdom

GSK Investigational Site

London SW9 8RR, United Kingdom

GSK Investigational Site

London WC1E 6JB, United Kingdom

GSK Investigational Site

Plymouth PL68DH, United Kingdom

Data sourced from ClinicalTrials.gov · Last verified: 2026-06