Last updated: 04/09/2025 09:40:09
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)B-Sure
GSK study ID
206882
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Trial status
Recruiting
Recruiting
Trial overview
Official title: 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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Percentage of Not-on-NA participants without loss of parent study primary outcome (PSPO)
Timeframe: From primary endpoint assessment in the parent study up to Month 57
Percentage of On-NA participants rolling over from studies 209668 and 209348 without loss of functional cure (FC) after NA-cessation in study 206882
Timeframe: From Month 3 up to Month 57
Percentage of On-NA participants rolling over from study 217023 without loss of FC after NA-cessation in study 206882
Timeframe: From Month 3 up to Month 33
Percentage of NA-cessated participants rolling over from studies 202009 and 219288 without loss of FC after NA-cessation in the parent study
Timeframe: From primary endpoint assessment in the parent study up to Month 33
Secondary outcomes:
Percentage of On-NA and NA-cessated participants with PSPO in the parent study who have hepatitis B surface antigen (HBsAg) reversion or use of any rescue medication after NA cessation (in either parent study or study 206682)
Timeframe: Up to Month 57
Percentage of On-NA and NA-cessated participants with PSPO in the parent study who have virologic relapse or use of any rescue medication after NA cessation (in either parent study or study 206682)
Timeframe: Up to Month 57
Percentage of On-NA and NA-cessated participants with PSPO in the parent study who have clinical relapse or use of any rescue medication after NA cessation (in either parent study or study 206682)
Timeframe: Up to Month 57
Percentage of On-NA and NA-cessated participants with PSPO in the parent study who receive NA retreatment after NA cessation (in either parent study or study 206682)
Timeframe: Up to Month 57
Percentage of On-NA participants with PSPO in the parent study, who continue NA treatment in study 206882, and have no loss of treatment response
Timeframe: From primary endpoint assessment in the parent study up to Month 33
Percentage of Not-on-NA participants with a partial response in the parent study and a delayed FC in study 206882 in absence of rescue medication after end of treatment in the parent study
Timeframe: Up to Month 57
Time to loss of FC from time of achieving delayed FC in Not-on-NA participants with a partial response in the parent study and a delayed FC in study 206882
Timeframe: From date of achieving delayed FC up to Month 57
Percentage of On-NA participants with a partial response in the parent study, who discontinue NA treatment in study 206882, and have a delayed FC in 206882 in absence of rescue medication after end of treatment in the parent study
Timeframe: Up to Month 57
Time to loss of FC in On-NA participants who achieve a partial response in the parent study, discontinue NA treatment in study 206882 and achieve delayed FC in 206882
Timeframe: From date of achieving delayed FC up to Month 57
Percentage of On-NA participants with a partial response in the parent study, who do not discontinue NA treatment in study 206882, and have a delayed treatment response in 206882 in absence of rescue medication after end of treatment in the parent study
Timeframe: Up to Month 33
Time to loss of treatment response in On-NA participants who achieve a partial response in the parent study, do not discontinue NA treatment in study 206882 and have a delayed treatment response in 206882
Timeframe: From date of achieving delayed treatment response up to Month 33
Percentage of On-NA participants with a partial response in the parent study, who discontinue NA treatment in study 206882, and have HBsAg loss in the absence of any rescue medication after NA cessation in 206882
Timeframe: From Month 3 to Month 57
Percentage of On-NA participants with a partial response in the parent study, who discontinue NA treatment in study 206882, and have virologic relapse or use of any rescue medication after NA cessation in 206882
Timeframe: From Month 3 up to Month 57
Percentage of On-NA participants with a partial response in the parent study, who discontinue NA treatment in study 206882, and have clinical relapse or use of any rescue medication after NA cessation in 206882
Timeframe: From Month 3 up to Month 57
Percentage of On-NA participants with a partial response in the parent study, who discontinue NA treatment in study 206882 and have use of any rescue medication after NA cessation in 206882
Timeframe: From Month 3 up to Month 57
Percentage of participants with anti-HBs (antibody to HBsAg)
Timeframe: Up to 57 months
Percentage of participants with anti-HBe (antibody to hepatitis B e-antigen [HBeAg])
Timeframe: Up to 57 months
Absolute values for HBsAg, hepatitis B virus (HBV) deoxyribonucleic acid (DNA), HBeAg (logarithm to the base 10 [log10] international units per milliliter [IU/mL])
Timeframe: Up to 57 months
Change from Baseline for HBsAg, HBV DNA, HBeAg (log10 IU/mL)
Timeframe: Baseline (End of Study visit in the parent study) and up to 57 months
Absolute values for hepatitis B core-related antigen (HBcrAg) (kiloUnits per milliliter [kU/mL])
Timeframe: Up to 57 months
Change from Baseline for HBcrAg (kU/mL)
Timeframe: Baseline (End of Study visit in the parent study) and up to 57 months
Absolute values for HBV ribonucleic acid (RNA) (log10 IU/ml)
Timeframe: Up to 57 months
Change from Baseline for HBV RNA (log10 IU/ml)
Timeframe: Baseline (End of Study visit in the parent study) and up to 57 months
Percentage of participants with mutations
Timeframe: Up to 57 months
Interventions:
Drug: Bepirovirsen
Drug: Placebo
Enrollment:
450
Observational study model:
Not applicable
Primary completion date:
2029-08-02
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Hepatitis B
Product
Not applicable
Collaborators
Not applicable
Study date(s)
December 2021 to February 2029
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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.
- 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.
Inclusion and 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 a. 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 b. 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
a. NA cessated at Week 48 in parent study and achieved at least HBsAg <1 IU/ml and HBV DNA
- Participants who have previously received at least 1 dose of bepirovirsen AND a. Achieved HBsAg <1 IU/ml and HBV DNA
- Participants who have previously received at least 1 dose of bepirovirsen AND a. Achieved HBsAg <1 IU/ml and HBV DNA
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.
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
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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