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RECRUITING
NCT04954859
PHASE2

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

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

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