Bepirovirsen: No study drug will be administered in this study. Eligible participants who received prior treatment with bepirovirsen in the parent studies will be included.
Placebo: No study drug will be administered in this study. Eligible participants who received prior treatment with placebo in the parent studies (209668, 202009, and 219288) will be included to maintain the blind in the still ongoing parent studies.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Percentage of Not-on-NA participants without loss of parent study primary outcome (PSPO) — From primary endpoint assessment in the parent study up to Month 57 NA indicates nucleos(t)ide analogue (NA).
Percentage of On-NA participants rolling over from studies 209668 and 209348 without loss of functional cure (FC) after NA-cessation in study 206882 — 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 — 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 — From primary endpoint assessment in the parent study up to Month 33
Trial sites (163)
Facility
City
Region
Status
GSK Investigational Site
Sacramento
California
GSK Investigational Site
San Jose
California
GSK Investigational Site
Colorado Springs
Colorado
GSK Investigational Site
Boston
Massachusetts
GSK Investigational Site
Detroit
Michigan
GSK Investigational Site
La Plata
Buenos Aires
GSK Investigational Site
Buenos Aires
Argentina
GSK Investigational Site
Buenos Aires
Argentina
GSK Investigational Site
Rosario
Argentina
GSK Investigational Site
Santa Fe
Argentina
GSK Investigational Site
Herston
Queensland
GSK Investigational Site
Fitzroy
Victoria
GSK Investigational Site
Aracaju
Sergipe
GSK Investigational Site
Campinas
Brazil
GSK Investigational Site
Curitiba
Brazil
GSK Investigational Site
Manaus
Brazil
GSK Investigational Site
São Paulo
Brazil
GSK Investigational Site
Vila Mariana
Brazil
GSK Investigational Site
Plovdiv
Bulgaria
GSK Investigational Site
Sliven
Bulgaria
GSK Investigational Site
Sofia
Bulgaria
GSK Investigational Site
Sofia
Bulgaria
GSK Investigational Site
Sofia
Bulgaria
GSK Investigational Site
Varna
Bulgaria
GSK Investigational Site
Calgary
Alberta
GSK Investigational Site
Victoria
British Columbia
GSK Investigational Site
Toronto
Ontario
GSK Investigational Site
Montreal
Quebec
GSK Investigational Site
Montreal
Quebec
GSK Investigational Site
Québec
Quebec
GSK Investigational Site
Beijing
China
GSK Investigational Site
Beijing
China
GSK Investigational Site
Beijing
China
GSK Investigational Site
Chengdu
China
GSK Investigational Site
Chengdu
China
GSK Investigational Site
Chongqing
China
GSK Investigational Site
Fuzhou
China
GSK Investigational Site
Guangzhou
China
GSK Investigational Site
Guangzhou
China
GSK Investigational Site
Guangzhou
China
+ 123 more sites — see the full list on the official registry below.
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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