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

Last updated: June 22, 2026
Sponsor: GlaxoSmithKline
Overall Status: Active - Not Recruiting

Phase

2

Condition

Hepatitis B

Hepatitis

Treatment

Placebo

Bepirovirsen

GSK3228836

Clinical Study ID

NCT04954859
206882
2023-506867-33
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion criteria:

  • Participants who enter the study on stable NA are willing and able to cease their NAtreatment 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 theEnd of Study (EoS) visit in their parent study (defined as complete respondersto bepirovirsen from the parent study) OR

  2. Demonstrated hepatitis B virus surface antigen (HBsAg) reduction greater thanor equal to (≥) 1.0 log10 international units per milliliter (IU/mL) fromparent study Baseline with HBsAg levels less than (<) 100 IU/mL and HBVdeoxyribonucleic acid (DNA) < lower limit of quantification (LLOQ) for 24 weeksafter the actual end of treatment regimen, in the absence of rescue medicationand 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 (ormatching placebo where appropriate) AND
  1. NA cessated at Week 48 in parent study and achieved at least HBsAg <1 IU/ml andHBV 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 stoppedNA treatment, and are maintaining at least HBsAg <1 IU/ml and HBV DNA <LLOQ atEOS visit (Week 72) of parent study OR

  3. Did not achieve NA cessation criteria in parent study but achieved at leastHBsAg <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 (ASO12arm) 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)] inparent 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 HBVDNA < LLOQ by the EOS visit (Week 133 (ASO12 arm) or Week 145 (ASO24 arm)) inthe parent study.

Exclusion

Exclusion Criteria:

  • Participants who have/or are currently participating in another non-GSKinterventional clinical study exploring HBV treatment since completing theirtreatment with bepirovirsen.

  • Any condition which, in the opinion of the investigator or Medical Monitor,contraindicates their participation in this study.

Study Design

Total Participants: 360
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 2
Study Start date:
December 14, 2021
Estimated Completion Date:
January 24, 2029

Connect with a study center

  • GSK Investigational Site

    La Plata, Buenos Aires B1902AWL
    Argentina

    Site Not Available

  • GSK Investigational Site

    Buenos Aires, C1425AGC
    Argentina

    Site Not Available

  • GSK Investigational Site

    Rosario, 2000
    Argentina

    Site Not Available

  • GSK Investigational Site

    Santa Fe, 3000
    Argentina

    Site Not Available

  • GSK Investigational Site

    Herston, Queensland 4029
    Australia

    Site Not Available

  • GSK Investigational Site

    Fitzroy, Victoria 3065
    Australia

    Site Not Available

  • GSK Investigational Site

    Aracaju, Sergipe 49055-000
    Brazil

    Site Not Available

  • GSK Investigational Site

    Campinas, 13060-803
    Brazil

    Site Not Available

  • GSK Investigational Site

    Curitiba, 30140-073
    Brazil

    Site Not Available

  • GSK Investigational Site

    Manaus, 69040000
    Brazil

    Site Not Available

  • GSK Investigational Site

    São Paulo, 05403-000
    Brazil

    Site Not Available

  • GSK Investigational Site

    Vila Mariana, 04121-000
    Brazil

    Site Not Available

  • GSK Investigational Site

    Plovdiv, 4000
    Bulgaria

    Site Not Available

  • GSK Investigational Site

    Sliven, 8800
    Bulgaria

    Site Not Available

  • GSK Investigational Site

    Sofia, 1431
    Bulgaria

    Site Not Available

  • GSK Investigational Site

    Varna, 9010
    Bulgaria

    Site Not Available

  • GSK Investigational Site

    Calgary, Alberta T2N 4Z6
    Canada

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  • GSK Investigational Site

    Victoria, British Columbia V8R 6R3
    Canada

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  • GSK Investigational Site

    Toronto, Ontario M5G 2C4
    Canada

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  • GSK Investigational Site

    Montreal, Quebec H4A 3J1
    Canada

    Site Not Available

  • GSK Investigational Site

    Québec, Quebec G1V 4G2
    Canada

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  • GSK Investigational Site

    Beijing, 100015
    China

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  • GSK Investigational Site

    Chengdu, 610072
    China

    Site Not Available

  • GSK Investigational Site

    Chongqing, 400042
    China

    Site Not Available

  • GSK Investigational Site

    Fuzhou, 350028
    China

    Site Not Available

  • GSK Investigational Site

    Guangzhou, 510440
    China

    Site Not Available

  • GSK Investigational Site

    Hangzhou, 310014
    China

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  • GSK Investigational Site

    Kunming, 650021
    China

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  • GSK Investigational Site

    Liuzhou,
    China

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  • GSK Investigational Site

    Shanghai, 200025
    China

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  • GSK Investigational Site

    Shenzhen, 518112
    China

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  • GSK Investigational Site

    Tianjin, 300000
    China

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  • GSK Investigational Site

    Wuhan, 430030
    China

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  • GSK Investigational Site

    Xi'an, 710061
    China

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  • GSK Investigational Site

    Xiamen, 361015
    China

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  • GSK Investigational Site

    Zhenjiang,
    China

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  • GSK Investigational Site

    Zunyi, 563114
    China

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  • GSK Investigational Site

    Ürümqi, 830054
    China

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    Clichy, 92110
    France

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    Lyon, 69317
    France

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    Paris,
    France

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  • GSK Investigational Site

    Pessac, 33604
    France

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  • GSK Investigational Site

    Rennes, 35000
    France

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    Strasbourg, 67200
    France

    Site Not Available

  • GSK Investigational Site

    Düsseldorf, North Rhine-Westphalia 40225
    Germany

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  • GSK Investigational Site

    Berlin, 12157
    Germany

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  • GSK Investigational Site

    Frankfurt am Main, 60329
    Germany

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  • GSK Investigational Site

    Hamburg, 20146
    Germany

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    Athens, 10676
    Greece

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    Heraklion, 711 10
    Greece

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    Kowloon,
    Hong Kong

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    Pokfulam,
    Hong Kong

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    Budapest, 1097
    Hungary

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    Belagavi, 590010
    India

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    Coimbatore, 641005
    India

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    Hyderabad,
    India

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    Kanchan Bagh Hyderabad, 40000
    India

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    Mumbai, 400008
    India

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    New Delhi, 110070
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    Pune, 411001
    India

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    Surat, 395002
    India

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  • GSK Investigational Site

    Bergamo, 24127
    Italy

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  • GSK Investigational Site

    Milan, 20122
    Italy

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  • GSK Investigational Site

    Milano, 20157
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Modena, 40126
    Italy

    Site Not Available

  • GSK Investigational Site

    Naples, 80131
    Italy

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  • GSK Investigational Site

    Palermo, 90127
    Italy

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    Pisa, 56124
    Italy

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  • GSK Investigational Site

    Gifu, 503-8502
    Japan

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  • GSK Investigational Site

    Hiroshima, 734-8551
    Japan

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  • GSK Investigational Site

    Hokkaido, 006-0811
    Japan

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    Ishikawa, 920-8650
    Japan

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  • GSK Investigational Site

    Kagawa, 760-8557
    Japan

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  • GSK Investigational Site

    Kumamoto, 860-8556
    Japan

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  • GSK Investigational Site

    Miyagi, 980-8574
    Japan

    Site Not Available

  • GSK Investigational Site

    Niigata, 950-1104
    Japan

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  • GSK Investigational Site

    Osaka, 565-0871
    Japan

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  • GSK Investigational Site

    Tokyo, 113-8519
    Japan

    Site Not Available

  • GSK Investigational Site

    Yamaguchi, 750-0061
    Japan

    Site Not Available

  • GSK Investigational Site

    Ansan-si Gyenggi-do, 15355
    Korea, Republic of

    Active - Recruiting

  • GSK Investigational Site

    Busan, 47392
    Korea, Republic of

    Active - Recruiting

  • GSK Investigational Site

    Pusan, 49241
    Korea, Republic of

    Active - Recruiting

  • GSK Investigational Site

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

  • GSK Investigational Site

    Kuala Terengganu, 20400
    Malaysia

    Site Not Available

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    Auckland, 01042
    New Zealand

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  • GSK Investigational Site

    Panama City, 7196
    Panama

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  • GSK Investigational Site

    Cebu City, 6000
    Philippines

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  • GSK Investigational Site

    Silang, 4118
    Philippines

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  • GSK Investigational Site

    Gdansk, 80-405
    Poland

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  • GSK Investigational Site

    Krakow, 31-202
    Poland

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  • GSK Investigational Site

    Lublin,
    Poland

    Site Not Available

  • GSK Investigational Site

    Mysłowice, 41-400
    Poland

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  • GSK Investigational Site

    Łańcut, 37-100
    Poland

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  • GSK Investigational Site

    Żychlin, 62-571
    Poland

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  • GSK Investigational Site

    Bucharest, 021105
    Romania

    Site Not Available

  • GSK Investigational Site

    Craiova Dolj, 417307
    Romania

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  • GSK Investigational Site

    Galati, 800179
    Romania

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  • GSK Investigational Site

    Oradea, 410469
    Romania

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  • GSK Investigational Site

    Chelyabinsk, 454052
    Russia

    Site Not Available

  • GSK Investigational Site

    Moscow, 121170
    Russia

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  • GSK Investigational Site

    Novosibirsk, 630099
    Russia

    Site Not Available

  • GSK Investigational Site

    Saint Petersburg, 191167
    Russia

    Site Not Available

  • GSK Investigational Site

    Samara, 443063
    Russia

    Site Not Available

  • GSK Investigational Site

    Красноярск, 660049
    Russia

    Site Not Available

  • GSK Investigational Site

    Chelyabinsk, 454052
    Russian Federation

    Active - Recruiting

  • GSK Investigational Site

    Moscow, 121170
    Russian Federation

    Active - Recruiting

  • GSK Investigational Site

    Novosibirsk, 630099
    Russian Federation

    Active - Recruiting

  • GSK Investigational Site

    Samara, 443063
    Russian Federation

    Active - Recruiting

  • GSK Investigational Site

    Singapore, 529889
    Singapore

    Site Not Available

  • GSK Investigational Site

    Durban, 4091
    South Africa

    Site Not Available

  • GSK Investigational Site

    Johannesburg, 1830
    South Africa

    Site Not Available

  • GSK Investigational Site

    Ansan-si Gyenggi-do, 15355
    South Korea

    Site Not Available

  • GSK Investigational Site

    Busan, 47392
    South Korea

    Site Not Available

  • GSK Investigational Site

    Pusan, 49241
    South Korea

    Site Not Available

  • GSK Investigational Site

    Seoul, 05505
    South Korea

    Site Not Available

  • GSK Investigational Site

    HebrOn, 08035
    Spain

    Site Not Available

  • GSK Investigational Site

    León, 24080
    Spain

    Site Not Available

  • GSK Investigational Site

    Madrid, 28031
    Spain

    Site Not Available

  • GSK Investigational Site

    Santander, 39008
    Spain

    Site Not Available

  • GSK Investigational Site

    Valencia, 46026
    Spain

    Site Not Available

  • GSK Investigational Site

    Vigo, 36071
    Spain

    Site Not Available

  • GSK Investigational Site

    Kaohsiung City, 807
    Taiwan

    Site Not Available

  • GSK Investigational Site

    Taichung, 40447
    Taiwan

    Site Not Available

  • GSK Investigational Site

    Tainan, 70403
    Taiwan

    Site Not Available

  • GSK Investigational Site

    Taipei, 10002
    Taiwan

    Site Not Available

  • GSK Investigational Site

    Taipei County, 104
    Taiwan

    Site Not Available

  • GSK Investigational Site

    Taoyuan, 333
    Taiwan

    Site Not Available

  • GSK Investigational Site

    Bangkok, 10330
    Thailand

    Site Not Available

  • GSK Investigational Site

    Chiang Mai, 50200
    Thailand

    Site Not Available

  • GSK Investigational Site

    Kho Hong Hat Yai, 90110
    Thailand

    Site Not Available

  • GSK Investigational Site

    Cottingham, HU16 5JQ
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Liverpool, L7 8XP
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    London, WC1E 6JB
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Plymouth, PL68DH
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Sacramento, California 95817
    United States

    Site Not Available

  • GSK Investigational Site

    San Jose, California 95128
    United States

    Site Not Available

  • GSK Investigational Site

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • GSK Investigational Site

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • GSK Investigational Site

    Detroit, Michigan 48202
    United States

    Site Not Available

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