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ACTIVE NOT 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

360

Start Date

2021-12-14

Completion Date

2029-01-24

Last Updated

2026-06-24

Healthy Volunteers

Conditions

Hepatitis B

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.

Inclusion criteria: * Participants who enter the study on stable NA are willing and able to cease their NA treatment 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 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: * Participants who have/or are currently participating in another non-GSK interventional clinical study exploring HBV treatment since completing their treatment with bepirovirsen. * Any condition which, in the opinion of the investigator or Medical Monitor, contraindicates their participation in this study.

Locations (163)

GSK Investigational Site

Sacramento, California, United States

GSK Investigational Site

San Jose, California, United States

GSK Investigational Site

Colorado Springs, Colorado, United States

GSK Investigational Site

Boston, Massachusetts, United States

GSK Investigational Site

Detroit, Michigan, United States

GSK Investigational Site

La Plata, Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Rosario, Argentina

GSK Investigational Site

Santa Fe, Argentina

GSK Investigational Site

Herston, Queensland, Australia

GSK Investigational Site

Fitzroy, Victoria, Australia

GSK Investigational Site

Aracaju, Sergipe, Brazil

GSK Investigational Site

Campinas, Brazil

GSK Investigational Site

Curitiba, Brazil

GSK Investigational Site

Manaus, Brazil

GSK Investigational Site

São Paulo, Brazil

GSK Investigational Site

Vila Mariana, Brazil

GSK Investigational Site

Plovdiv, Bulgaria

GSK Investigational Site

Sliven, Bulgaria

GSK Investigational Site

Sofia, Bulgaria

GSK Investigational Site

Sofia, Bulgaria

GSK Investigational Site

Sofia, Bulgaria

GSK Investigational Site

Varna, Bulgaria

GSK Investigational Site

Calgary, Alberta, Canada

GSK Investigational Site

Victoria, British Columbia, Canada

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Montreal, Quebec, Canada

GSK Investigational Site

Montreal, Quebec, Canada

GSK Investigational Site

Québec, Quebec, Canada

GSK Investigational Site

Beijing, China

GSK Investigational Site

Beijing, China

GSK Investigational Site

Beijing, China

GSK Investigational Site

Chengdu, China

GSK Investigational Site

Chengdu, China

GSK Investigational Site

Chongqing, China

GSK Investigational Site

Fuzhou, China

GSK Investigational Site

Guangzhou, China

GSK Investigational Site

Guangzhou, China

GSK Investigational Site

Guangzhou, China

GSK Investigational Site

Hangzhou, China

GSK Investigational Site

Hangzhou, China

GSK Investigational Site

Kunming, China

GSK Investigational Site

Liuzhou, China

GSK Investigational Site

Shanghai, China

GSK Investigational Site

Shanghai, China

GSK Investigational Site

Shanghai, China

GSK Investigational Site

Shenzhen, China

GSK Investigational Site

Tianjin, China

GSK Investigational Site

Ürümqi, China

GSK Investigational Site

Wuhan, China

GSK Investigational Site

Xi'an, China

GSK Investigational Site

Xiamen, China

GSK Investigational Site

Zhenjiang, China

GSK Investigational Site

Zunyi, China

GSK Investigational Site

Clichy, France

GSK Investigational Site

Lyon, France

GSK Investigational Site

Paris, France

GSK Investigational Site

Pessac, France

GSK Investigational Site

Rennes, France

GSK Investigational Site

Strasbourg, France

GSK Investigational Site

Düsseldorf, North Rhine-Westphalia, Germany

GSK Investigational Site

Berlin, Germany

GSK Investigational Site

Berlin, Germany

GSK Investigational Site

Frankfurt am Main, Germany

GSK Investigational Site

Hamburg, Germany

GSK Investigational Site

Athens, Greece

GSK Investigational Site

Athens, Greece

GSK Investigational Site

Heraklion, Greece

GSK Investigational Site

Kowloon, Hong Kong

GSK Investigational Site

Pokfulam, Hong Kong

GSK Investigational Site

Budapest, Hungary

GSK Investigational Site

Belagavi, India

GSK Investigational Site

Coimbatore, India

GSK Investigational Site

Hyderabad, India

GSK Investigational Site

Kanchan Bagh Hyderabad, India

GSK Investigational Site

Mumbai, India

GSK Investigational Site

Mumbai, India

GSK Investigational Site

Mumbai, India

GSK Investigational Site

New Delhi, India

GSK Investigational Site

Pune, India

GSK Investigational Site

Surat, India

GSK Investigational Site

Bergamo, Italy

GSK Investigational Site

Milan, Italy

GSK Investigational Site

Milan, Italy

GSK Investigational Site

Modena, Italy

GSK Investigational Site

Naples, Italy

GSK Investigational Site

Palermo, Italy

GSK Investigational Site

Pisa, Italy

GSK Investigational Site

Gifu, Japan

GSK Investigational Site

Gifu, Japan

GSK Investigational Site

Hiroshima, Japan

GSK Investigational Site

Hiroshima, Japan

GSK Investigational Site

Hokkaido, Japan

GSK Investigational Site

Ishikawa, Japan

GSK Investigational Site

Kagawa, Japan

GSK Investigational Site

Kumamoto, Japan

GSK Investigational Site

Kumamoto, Japan

GSK Investigational Site

Miyagi, Japan

GSK Investigational Site

Niigata, Japan

And 63 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (163)