Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
NCT ID: NCT04954859
Last Updated: 2025-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
450 participants
INTERVENTIONAL
2021-12-14
2029-02-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Not-on-NA participants
Participants 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.
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.
On-NA participants
Participants 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.
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.
NA-cessated participants
Participants 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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Any condition which, in the opinion of the investigator or Medical Monitor, contraindicates their participation in this study.
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Sacramento, California, United States
GSK Investigational Site
Boston, Massachusetts, United States
GSK Investigational Site
Detroit, Michigan, United States
GSK Investigational Site
Buenos Aires, , Argentina
GSK Investigational Site
Sliven, , Bulgaria
GSK Investigational Site
Sofia, , Bulgaria
GSK Investigational Site
Calgary, Alberta, Canada
GSK Investigational Site
Victoria, British Columbia, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Hangzhou, , China
GSK Investigational Site
Shanghai, , China
GSK Investigational Site
Wuhan, , China
GSK Investigational Site
Clichy, , France
GSK Investigational Site
Strasbourg, , France
GSK Investigational Site
Pokfulam, , Hong Kong
GSK Investigational Site
Milan, , Italy
GSK Investigational Site
Milan, , Italy
GSK Investigational Site
Modena, , Italy
GSK Investigational Site
Hiroshima, , Japan
GSK Investigational Site
Hiroshima, , Japan
GSK Investigational Site
Ishikawa, , Japan
GSK Investigational Site
Kagawa, , Japan
GSK Investigational Site
Kumamoto, , Japan
GSK Investigational Site
Miyagi, , Japan
GSK Investigational Site
Osaka, , Japan
GSK Investigational Site
Tokyo, , Japan
GSK Investigational Site
Tokyo, , Japan
GSK Investigational Site
Lublin, , Poland
GSK Investigational Site
Craiova Dolj, , Romania
GSK Investigational Site
Galati, , Romania
GSK Investigational Site
Chelyabinsk, , Russia
GSK Investigational Site
Moscow, , Russia
GSK Investigational Site
Novosibirsk, , Russia
GSK Investigational Site
Saint Petersburg, , Russia
GSK Investigational Site
Saint Petersburg, , Russia
GSK Investigational Site
Samara, , Russia
GSK Investigational Site
Красноярск, , Russia
GSK Investigational Site
Singapore, , Singapore
GSK Investigational Site
Singapore, , Singapore
GSK Investigational Site
Durban, , South Africa
GSK Investigational Site
Johannesburg, , South Africa
GSK Investigational Site
Ansan-si Gyenggi-do, , South Korea
GSK Investigational Site
Busan, , South Korea
GSK Investigational Site
Pusan, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Santander, , Spain
GSK Investigational Site
Bangkok, , Thailand
GSK Investigational Site
Kho Hong Hat Yai, , Thailand
GSK Investigational Site
London, , United Kingdom
GSK Investigational Site
Plymouth, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-506867-33
Identifier Type: OTHER
Identifier Source: secondary_id
206882
Identifier Type: -
Identifier Source: org_study_id
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