Actively Recruiting
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Led by GlaxoSmithKline · Updated on 2025-04-10
450
Participants Needed
51
Research Sites
373 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants who are willing and able to stop their NA treatment following the NA cessation schedule.
- Able to give informed consent.
- Previously received at least one dose of bepirovirsen in a parent study.
- For certain parent studies, must have achieved complete response or specific reductions in hepatitis B surface antigen (HBsAg) and HBV DNA levels maintained until the end of the parent study.
- For other parent studies, must meet specific criteria related to NA cessation, HBsAg levels less than 1 IU/ml, and HBV DNA levels below the lower limit of quantification at specified study weeks.
- Participants rolling over from the TH HBV ASO-001 study must meet defined HBsAg and HBV DNA level criteria at specific weeks or end-of-study visits in the parent study.
You will not qualify if you...
- Participation in another non-GSK interventional clinical study for hepatitis B treatment since finishing bepirovirsen treatment.
- Any condition that an investigator or Medical Monitor believes makes participation unsafe or unsuitable.
AI-Screening
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Trial Site Locations
Total: 51 locations
1
GSK Investigational Site
Sacramento, California, United States, 95817
Actively Recruiting
2
GSK Investigational Site
Boston, Massachusetts, United States, 02114
Actively Recruiting
3
GSK Investigational Site
Detroit, Michigan, United States, 48202
Actively Recruiting
4
GSK Investigational Site
Buenos Aires, Argentina, C1181ACH
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5
GSK Investigational Site
Sliven, Bulgaria, 8800
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6
GSK Investigational Site
Sofia, Bulgaria, 1431
Actively Recruiting
7
GSK Investigational Site
Calgary, Alberta, Canada, T2N 4Z6
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8
GSK Investigational Site
Victoria, British Columbia, Canada, V8R 6R3
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9
GSK Investigational Site
Toronto, Ontario, Canada, M5G 2C4
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10
GSK Investigational Site
Hangzhou, China, 310000
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11
GSK Investigational Site
Shanghai, China, 200025
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12
GSK Investigational Site
Wuhan, China, 430030
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13
GSK Investigational Site
Clichy, France, 92110
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14
GSK Investigational Site
Strasbourg, France, 67200
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15
GSK Investigational Site
Pokfulam, Hong Kong
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16
GSK Investigational Site
Milan, Italy, 20122
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17
GSK Investigational Site
Milan, Italy, 20157
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18
GSK Investigational Site
Modena, Italy, 40126
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19
GSK Investigational Site
Hiroshima, Japan, 730-8619
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20
GSK Investigational Site
Hiroshima, Japan, 734-8551
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21
GSK Investigational Site
Ishikawa, Japan, 920-8650
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22
GSK Investigational Site
Kagawa, Japan, 760-8557
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23
GSK Investigational Site
Kumamoto, Japan, 862-8655
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24
GSK Investigational Site
Miyagi, Japan, 980-8574
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25
GSK Investigational Site
Osaka, Japan, 565-0871
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26
GSK Investigational Site
Tokyo, Japan, 113-8603
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27
GSK Investigational Site
Tokyo, Japan, 180-8610
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28
GSK Investigational Site
Lublin, Poland, 20081
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29
GSK Investigational Site
Craiova Dolj, Romania, 417307
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30
GSK Investigational Site
Galati, Romania, 800179
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31
GSK Investigational Site
Chelyabinsk, Russia, 454052
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32
GSK Investigational Site
Moscow, Russia, 121170
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33
GSK Investigational Site
Novosibirsk, Russia, 630099
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34
GSK Investigational Site
Saint Petersburg, Russia, 190103
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35
GSK Investigational Site
Saint Petersburg, Russia, 191167
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36
GSK Investigational Site
Samara, Russia, 443063
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37
GSK Investigational Site
Красноярск, Russia, 660049
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38
GSK Investigational Site
Singapore, Singapore, 119074
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39
GSK Investigational Site
Singapore, Singapore, 529889
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40
GSK Investigational Site
Durban, South Africa, 4091
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41
GSK Investigational Site
Johannesburg, South Africa, 1830
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42
GSK Investigational Site
Ansan-si Gyenggi-do, South Korea, 15355
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43
GSK Investigational Site
Busan, South Korea, 47392
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44
GSK Investigational Site
Pusan, South Korea, 49241
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45
GSK Investigational Site
Seoul, South Korea, 05505
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46
GSK Investigational Site
Madrid, Spain, 28031
Actively Recruiting
47
GSK Investigational Site
Santander, Spain, 39008
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48
GSK Investigational Site
Bangkok, Thailand, 10400
Actively Recruiting
49
GSK Investigational Site
Kho Hong Hat Yai, Thailand, 90110
Actively Recruiting
50
GSK Investigational Site
London, United Kingdom, WC1E 6JB
Actively Recruiting
51
GSK Investigational Site
Plymouth, United Kingdom, PL68DH
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
CONTACT
E
EU GSK Clinical Trials Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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