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ACTIVE NOT RECRUITING
NCT06537414
PHASE2

A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

Summary

The study is intended to evaluate the efficacy and safety of 2 different doses of DAP/TOM followed by bepirovirsen in participants living with CHB on standard of care nucleos(t)ide analogue (NA) therapy. The study also aims to identify an optimal dose of DAP/TOM for sequenced therapy with bepirovirsen for further clinical development and to assess the contribution of DAP/TOM to the sequential regimen.

Official title: A Phase 2b, Multi-centre, Randomized, Partially Placebo-controlled, Double-blind Study to Investigate the Safety and Efficacy of Sequential Therapy With Daplusiran/Tomligisiran Followed by Bepirovirsen in Participants With Chronic Hepatitis B Virus on Background Nucleos(t)Ide Analogue Therapy (B-United)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

283

Start Date

2024-11-11

Completion Date

2027-05-31

Last Updated

2025-07-28

Healthy Volunteers

No

Interventions

DRUG

Daplusiran/Tomligisiran Dose Level 1

Daplusiran/Tomligisiran dose level 1 will be administered

DRUG

Daplusiran/Tomligisiran Dose Level 2

Daplusiran/Tomligisiran dose level 2 will be administered

DRUG

Bepirovirsen

Bepirovirsen will be administered

DRUG

Placebo

Placebo will be administered

Locations (81)

GSK Investigational Site

San Francisco, California, United States

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San Jose, California, United States

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Minneapolis, Minnesota, United States

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New York, New York, United States

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Philadelphia, Pennsylvania, United States

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Westmead, New South Wales, Australia

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Fitzroy, Victoria, Australia

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Brussels, Belgium

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Edegem, Belgium

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Ghent, Belgium

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Aracaju, Brazil

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Curitiba, Brazil

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Manaus, Brazil

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São Paulo, Brazil

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Calgary, Alberta, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Beijing, China

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Chengdu, China

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Guangzhou, China

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Shanghai, China

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Clichy, France

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Créteil, France

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Limoges, France

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Lyon, France

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Marseille, France

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Toulouse, France

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Berlin, Germany

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Berlin, Germany

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Hanover, Germany

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Münster, Germany

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Athens, Greece

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Athens, Greece

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Pokfulam, Hong Kong

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Shatin, Hong Kong

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Bergamo, Italy

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Florence, Italy

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Milan, Italy

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Naples, Italy

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Padova, Italy

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Pisa, Italy

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Roma, Italy

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Chiba, Japan

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Hokkaido, Japan

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Hokkaido, Japan

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Hyōgo, Japan

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Kagawa, Japan

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Kagawa, Japan

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Kumamoto, Japan

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Kumamoto, Japan

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Osaka, Japan

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Osaka, Japan

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Tokyo, Japan

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Yamanashi, Japan

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Auckland, New Zealand

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Papatoetoe Auckland, New Zealand

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Singapore, Singapore

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Singapore, Singapore

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Johannesburg, South Africa

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Reiger Park, South Africa

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Ansan, South Korea

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Busan, South Korea

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Pusan, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Barcelona, Spain

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Barcelona, Spain

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León, Spain

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Madrid, Spain

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Salamanca, Spain

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Santander, Spain

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Valencia, Spain

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Kaohsiung City, Taiwan

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Kaohsiung City, Taiwan

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Taichung, Taiwan

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Tau-Yuan, Taiwan

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London, United Kingdom

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London, United Kingdom

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London, United Kingdom

GSK Investigational Site

Middlesbrough, United Kingdom