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Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 2)
Sponsor: GlaxoSmithKline
Summary
This study is intended to confirm the efficacy, safety, pharmacokinetic (PK) profile, and the durability of hepatitis B virus surface antigen (HBsAg) suppression observed with bepirovirsen for 24 weeks (with loading doses) as compared to the placebo arm. This study will have 4 stages: a) Double-blind treatment (bepirovirsen or placebo) for 24 weeks. b) Nucleos(t)ide analogue (NA) treatment for 24 weeks. c) NA cessation stage OR Continue NA for 24 weeks. d) Durability of response and follow up for further 24 weeks for participants who stopped NA treatment at Week 48. The arms will be stratified based on HBsAg level (HBsAg greater than or equal to \[≥\] 100 international unit per milliliter \[IU/mL\] to less than or equal \[≤\]1000 IU/mL or greater than \[\>\] 1000 IU/mL to ≤3000 IU/mL) at screening. The total duration of the study, including screening (up to 60 days), the double-blind treatment stage (24 weeks), the On NA only stage (24 weeks), and the NA cessation and durability stages (48 weeks) is up to approximately 104 weeks at maximum for each participant.
Official title: Phase 3 Multicenter, Randomized, Double-Blind, Study to Assess the Efficacy and Safety of Treatment With Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B Virus (B-Well 2)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
857
Start Date
2022-12-06
Completion Date
2026-04-29
Last Updated
2025-12-12
Healthy Volunteers
No
Conditions
Interventions
Bepirovirsen
Bepirovirsen will be administered.
Placebo
Matching placebo will be administered.
Locations (171)
GSK Investigational Site
Centreville, Alabama, United States
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Los Angeles, California, United States
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San Francisco, California, United States
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San Francisco, California, United States
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Colorado Springs, Colorado, United States
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Ft. Pierce, Florida, United States
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Miami, Florida, United States
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Glen Burnie, Maryland, United States
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Minneapolis, Minnesota, United States
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Philadelphia, Pennsylvania, United States
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Denison, Texas, United States
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Seattle, Washington, United States
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Buenos Aires, Argentina
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Buenos Aires, Argentina
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Ciudad Autonoma de Bueno, Argentina
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Santa Fe, Argentina
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Westmead, New South Wales, Australia
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Herston, Queensland, Australia
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Box Hill, Victoria, Australia
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Fitzroy, Victoria, Australia
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Botucatu, Brazil
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Fortaleza, Brazil
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Nova Iguaçu, Brazil
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Porto Alegre, Brazil
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Porto Alegre, Brazil
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Rio de Janeiro, Brazil
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Salvador, Brazil
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Vitória, Brazil
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Plovdiv, Bulgaria
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Sliven, Bulgaria
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Sofia, Bulgaria
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Varna, Bulgaria
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Edmonton, Alberta, Canada
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Halifax, Nova Scotia, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Regina, Saskatchewan, Canada
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Beijing, China
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Beijing, China
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Changchun, China
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Chengdu, China
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Chongqing, China
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Guangzhou, China
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Guangzhou, China
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Hangzhou, China
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Hangzhou, China
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Hefei, China
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Kunming, China
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Liuchow, China
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Nanjing, China
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Shanghai, China
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Shanghai, China
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Shenzhen, China
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Taiyuan, China
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Tianjin, China
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Ürümqi, China
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Wuhan, China
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Xi'an, China
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Xiamen, China
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Zhengzhou, China
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Zunyi, China
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Créteil, France
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Grenoble, France
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Limoges, France
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Lyon, France
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Paris, France
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Rouen, France
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Toulouse, France
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Frankfurt, Germany
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Frankfurt, Germany
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Hamburg, Germany
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Hanover, Germany
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Athens, Greece
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Heraklion Crete, Greece
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Thessaloniki, Greece
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Szeged, Hungary
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Székesfehérvár, Hungary
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Zalaegerszeg, Hungary
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Ahmedabad, India
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Chennai, India
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Kanpur, India
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Kochi, India
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Kolkata, India
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Kolkata, India
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Mumbai, India
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Mumbai, India
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Nagpur, India
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New Delhi, India
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New Delhi, India
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New Delhi, India
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Pune, India
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Raipur, India
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Secunderabad, India
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Milan, Italy
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Naples, Italy
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Padova, Italy
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Palermo, Italy
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Pisa, Italy
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Roma, Italy
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Sassari, Italy
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Torino, Italy
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Fukui, Japan
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Hiroshima, Japan
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Hokkaido, Japan
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Hokkaido, Japan
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Hokkaido, Japan
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Ishikawa, Japan
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Kagawa, Japan
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Kumamoto, Japan
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Nagasaki, Japan
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Nara, Japan
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Niigata, Japan
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Osaka, Japan
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Tokyo, Japan
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Yamaguchi, Japan
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Yamanashi, Japan
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Johor Bahru, Malaysia
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Kota Bharu Kelantan, Malaysia
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Kota Kinabalu, Malaysia
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Kuala Lumpur, Malaysia
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Kuala Terengganu, Malaysia
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Kuantan, Malaysia
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Aguascalientes, Mexico
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Auckland, New Zealand
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Papatoetoe Auckland, New Zealand
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Panama City, Panama
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Cebu City, Philippines
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Makati City, Philippines
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Pasig, Philippines
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Silang, Philippines
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Gdansk, Poland
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Mysłowice, Poland
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Żychlin, Poland
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Bucharest, Romania
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Bucharest, Romania
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Cluj-Napoca, Romania
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Constanța, Romania
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Galati, Romania
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Oradea, Romania
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Ansan, South Korea
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Incheon, 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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Ulsan, South Korea
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Alcorcon Madrid, Spain
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Badajoz, Spain
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Granada, Spain
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Madrid, Spain
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Madrid, Spain
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Madrid, Spain
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Sabadell Barcelona, Spain
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Seville, Spain
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Valencia, Spain
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Valladolid, Spain
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Zaragoza, Spain
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Kaohsiung City, Taiwan
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Taichung, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Chiang Mai, Thailand
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Ankara, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
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Liverpool, United Kingdom
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London, United Kingdom
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Middlesbrough, United Kingdom
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Newcastle upon Tyne, United Kingdom