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Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Sponsor: GlaxoSmithKline
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
450
Start Date
2021-12-14
Completion Date
2029-02-08
Last Updated
2025-04-10
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (51)
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