Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
B-Sure
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
2 other identifiers
interventional
360
29 countries
163
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2021
Longer than P75 for phase_2
163 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2021
CompletedFirst Posted
Study publicly available on registry
July 8, 2021
CompletedStudy Start
First participant enrolled
December 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 24, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 24, 2029
June 24, 2026
June 1, 2026
7.1 years
June 29, 2021
June 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Percentage of Not-on-NA participants without loss of parent study primary outcome (PSPO)
NA indicates nucleos(t)ide analogue (NA).
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
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
Secondary Outcomes (24)
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)
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)
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)
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)
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
From primary endpoint assessment in the parent study up to Month 33
- +19 more secondary outcomes
Study Arms (3)
Not-on-NA participants
EXPERIMENTALParticipants rolling over from study 209668 who have not received nucleos(t)ide analogue (NA) therapy during the parent study and remain off NAs will be included in this arm. Participants will be followed up for 33 months. Participants maintaining either functional cure (FC) or a partial response off NA treatment at Month 33 will be eligible to be followed up for an additional 2 years. No study treatment will be administered in this study.
On-NA participants
EXPERIMENTALParticipants rolling over from studies 209668, 209348, 212602, 202009, 219288, and 217023 who entered the parent study on stable NA therapy and remained on NA therapy for the duration of the treatment and follow-up periods in the parent study will be included in this arm. NA cessation will occur at 3 months in 206882 for eligible and willing participants. Participants will be followed up for 33 months. Participants rolling over from studies 209668 and 209348 who stopped NA treatment and are maintaining either FC or a partial response at Month 33, and remaining off NA treatment, will be eligible to be followed up for an additional 2 years. No study treatment will be administered in this study.
NA-cessated participants
EXPERIMENTALParticipants rolling over from studies 202009 and 219288 who have stopped NA treatment during the parent study will be included in this arm. Participants will be followed up for 33 months. No study treatment will be administered in this study.
Interventions
No study drug will be administered in this study. Eligible participants who received prior treatment with bepirovirsen in the parent studies will be included.
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.
Eligibility Criteria
You may qualify if:
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (163)
GSK Investigational Site
Sacramento, California, 95817, United States
GSK Investigational Site
San Jose, California, 95128, United States
GSK Investigational Site
Colorado Springs, Colorado, 80907, United States
GSK Investigational Site
Boston, Massachusetts, 02114, United States
GSK Investigational Site
Detroit, Michigan, 48202, United States
GSK Investigational Site
La Plata, Buenos Aires, B1902AWL, Argentina
GSK Investigational Site
Buenos Aires, C1181ACH, Argentina
GSK Investigational Site
Buenos Aires, C1425AGC, Argentina
GSK Investigational Site
Rosario, 2000, Argentina
GSK Investigational Site
Santa Fe, 3000, Argentina
GSK Investigational Site
Herston, Queensland, 4029, Australia
GSK Investigational Site
Fitzroy, Victoria, 3065, Australia
GSK Investigational Site
Aracaju, Sergipe, 49055-000, Brazil
GSK Investigational Site
Campinas, 13060-803, Brazil
GSK Investigational Site
Curitiba, 30140-073, Brazil
GSK Investigational Site
Manaus, 69040000, Brazil
GSK Investigational Site
São Paulo, 05403-000, Brazil
GSK Investigational Site
Vila Mariana, 04121-000, Brazil
GSK Investigational Site
Plovdiv, 4000, Bulgaria
GSK Investigational Site
Sliven, 8800, Bulgaria
GSK Investigational Site
Sofia, 1431, Bulgaria
GSK Investigational Site
Sofia, 1463, Bulgaria
GSK Investigational Site
Sofia, 1606, Bulgaria
GSK Investigational Site
Varna, 9010, Bulgaria
GSK Investigational Site
Calgary, Alberta, T2N 4Z6, Canada
GSK Investigational Site
Victoria, British Columbia, V8R 6R3, Canada
GSK Investigational Site
Toronto, Ontario, M5G 2C4, Canada
GSK Investigational Site
Montreal, Quebec, H2X 0A9, Canada
GSK Investigational Site
Montreal, Quebec, H4A 3J1, Canada
GSK Investigational Site
Québec, Quebec, G1V 4G2, Canada
GSK Investigational Site
Beijing, 100015, China
GSK Investigational Site
Beijing, 100039, China
GSK Investigational Site
Beijing, 100050, China
GSK Investigational Site
Chengdu, 610041, China
GSK Investigational Site
Chengdu, 610072, China
GSK Investigational Site
Chongqing, 400042, China
GSK Investigational Site
Fuzhou, 350028, China
GSK Investigational Site
Guangzhou, 510000, China
GSK Investigational Site
Guangzhou, 510440, China
GSK Investigational Site
Guangzhou, 510630, China
GSK Investigational Site
Hangzhou, 310014, China
GSK Investigational Site
Hangzhou, 310022, China
GSK Investigational Site
Kunming, 650021, China
GSK Investigational Site
Liuzhou, China
GSK Investigational Site
Shanghai, 200025, China
GSK Investigational Site
Shanghai, 200040, China
GSK Investigational Site
Shanghai, 201508, China
GSK Investigational Site
Shenzhen, 518112, China
GSK Investigational Site
Tianjin, 300000, China
GSK Investigational Site
Ürümqi, 830054, China
GSK Investigational Site
Wuhan, 430030, China
GSK Investigational Site
Xi'an, 710061, China
GSK Investigational Site
Xiamen, 361015, China
GSK Investigational Site
Zhenjiang, China
GSK Investigational Site
Zunyi, 563114, China
GSK Investigational Site
Clichy, 92110, France
GSK Investigational Site
Lyon, 69317, France
GSK Investigational Site
Paris, France
GSK Investigational Site
Pessac, 33604, France
GSK Investigational Site
Rennes, 35000, France
GSK Investigational Site
Strasbourg, 67200, France
GSK Investigational Site
Düsseldorf, North Rhine-Westphalia, 40225, Germany
GSK Investigational Site
Berlin, 12157, Germany
GSK Investigational Site
Berlin, 12163, Germany
GSK Investigational Site
Frankfurt am Main, 60329, Germany
GSK Investigational Site
Hamburg, 20146, Germany
GSK Investigational Site
Athens, 10676, Greece
GSK Investigational Site
Athens, 11527, Greece
GSK Investigational Site
Heraklion, 711 10, Greece
GSK Investigational Site
Kowloon, Hong Kong
GSK Investigational Site
Pokfulam, Hong Kong
GSK Investigational Site
Budapest, 1097, Hungary
GSK Investigational Site
Belagavi, 590010, India
GSK Investigational Site
Coimbatore, 641005, India
GSK Investigational Site
Hyderabad, India
GSK Investigational Site
Kanchan Bagh Hyderabad, 40000, India
GSK Investigational Site
Mumbai, 400008, India
GSK Investigational Site
Mumbai, 400012, India
GSK Investigational Site
Mumbai, 400022, India
GSK Investigational Site
New Delhi, 110070, India
GSK Investigational Site
Pune, 411001, India
GSK Investigational Site
Surat, 395002, India
GSK Investigational Site
Bergamo, 24127, Italy
GSK Investigational Site
Milan, 20122, Italy
GSK Investigational Site
Milan, 20157, Italy
GSK Investigational Site
Modena, 40126, Italy
GSK Investigational Site
Naples, 80131, Italy
GSK Investigational Site
Palermo, 90127, Italy
GSK Investigational Site
Pisa, 56124, Italy
GSK Investigational Site
Gifu, 500-8717, Japan
GSK Investigational Site
Gifu, 503-8502, Japan
GSK Investigational Site
Hiroshima, 730-8619, Japan
GSK Investigational Site
Hiroshima, 734-8551, Japan
GSK Investigational Site
Hokkaido, 006-0811, Japan
GSK Investigational Site
Ishikawa, 920-8650, Japan
GSK Investigational Site
Kagawa, 760-8557, Japan
GSK Investigational Site
Kumamoto, 860-8556, Japan
GSK Investigational Site
Kumamoto, 862-8655, Japan
GSK Investigational Site
Miyagi, 980-8574, Japan
GSK Investigational Site
Niigata, 950-1104, Japan
GSK Investigational Site
Osaka, 565-0871, Japan
GSK Investigational Site
Tokyo, 113-8519, Japan
GSK Investigational Site
Tokyo, 113-8603, Japan
GSK Investigational Site
Tokyo, 180-8610, Japan
GSK Investigational Site
Yamaguchi, 750-0061, Japan
GSK Investigational Site
Kuala Terengganu, 20400, Malaysia
GSK Investigational Site
Auckland, 01042, New Zealand
GSK Investigational Site
Panama City, 7196, Panama
GSK Investigational Site
Cebu City, 6000, Philippines
GSK Investigational Site
Silang, 4118, Philippines
GSK Investigational Site
Gdansk, 80-405, Poland
GSK Investigational Site
Krakow, 31-202, Poland
GSK Investigational Site
Lublin, Poland
GSK Investigational Site
Mysłowice, 41-400, Poland
GSK Investigational Site
Żychlin, 62-571, Poland
GSK Investigational Site
Łańcut, 37-100, Poland
GSK Investigational Site
Bucharest, 020125, Romania
GSK Investigational Site
Bucharest, 021105, Romania
GSK Investigational Site
Bucharest, 030303, Romania
GSK Investigational Site
Craiova Dolj, 417307, Romania
GSK Investigational Site
Galati, 800179, Romania
GSK Investigational Site
Oradea, 410469, Romania
GSK Investigational Site
Chelyabinsk, 454052, Russia
GSK Investigational Site
Moscow, 121170, Russia
GSK Investigational Site
Novosibirsk, 630099, Russia
GSK Investigational Site
Saint Petersburg, 190103, Russia
GSK Investigational Site
Saint Petersburg, 191167, Russia
GSK Investigational Site
Samara, 443063, Russia
GSK Investigational Site
Красноярск, 660049, Russia
GSK Investigational Site
Singapore, 119074, Singapore
GSK Investigational Site
Singapore, 169608, Singapore
GSK Investigational Site
Singapore, 529889, Singapore
GSK Investigational Site
Durban, 4091, South Africa
GSK Investigational Site
Johannesburg, 1830, South Africa
GSK Investigational Site
Ansan-si Gyenggi-do, 15355, South Korea
GSK Investigational Site
Busan, 47392, South Korea
GSK Investigational Site
Pusan, 49241, South Korea
GSK Investigational Site
Seoul, 03312, South Korea
GSK Investigational Site
Seoul, 05505, South Korea
GSK Investigational Site
Seoul, 08308, South Korea
GSK Investigational Site
HebrOn, 08035, Spain
GSK Investigational Site
León, 24080, Spain
GSK Investigational Site
Madrid, 28031, Spain
GSK Investigational Site
Santander, 39008, Spain
GSK Investigational Site
Valencia, 46026, Spain
GSK Investigational Site
Vigo, 36071, Spain
GSK Investigational Site
Kaohsiung City, 807, Taiwan
GSK Investigational Site
Kaohsiung City, 824, Taiwan
GSK Investigational Site
Kaohsiung City, 833, Taiwan
GSK Investigational Site
Taichung, 40447, Taiwan
GSK Investigational Site
Tainan, 70403, Taiwan
GSK Investigational Site
Taipei, 10002, Taiwan
GSK Investigational Site
Taipei County, 104, Taiwan
GSK Investigational Site
Taoyuan, 333, Taiwan
GSK Investigational Site
Bangkok, 10330, Thailand
GSK Investigational Site
Bangkok, 10400, Thailand
GSK Investigational Site
Chiang Mai, 50200, Thailand
GSK Investigational Site
Kho Hong Hat Yai, 90110, Thailand
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2021
First Posted
July 8, 2021
Study Start
December 14, 2021
Primary Completion (Estimated)
January 24, 2029
Study Completion (Estimated)
January 24, 2029
Last Updated
June 24, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
- Access Criteria
- Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
IPD for this study will be made available via the Clinical Study Data Request site.