Clinical Research Directory
Browse clinical research sites, groups, and studies.
Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 1)
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 1)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
981
Start Date
2022-12-07
Completion Date
2026-05-05
Last Updated
2025-12-15
Healthy Volunteers
No
Conditions
Interventions
Bepirovirsen
Bepirovirsen will be administered.
Placebo
Matching placebo will be administered.
Locations (177)
GSK Investigational Site
Chandler, Arizona, United States
GSK Investigational Site
Davis, California, United States
GSK Investigational Site
Los Angeles, California, United States
GSK Investigational Site
Palo Alto, California, United States
GSK Investigational Site
San Jose, California, United States
GSK Investigational Site
Littleton, Colorado, United States
GSK Investigational Site
Miami, Florida, United States
GSK Investigational Site
Iowa City, Iowa, United States
GSK Investigational Site
Baltimore, Maryland, United States
GSK Investigational Site
Detroit, Michigan, United States
GSK Investigational Site
Richmond, Virginia, United States
GSK Investigational Site
Richmond, Virginia, United States
GSK Investigational Site
Buenos Aires, Argentina
GSK Investigational Site
Buenos Aires, Argentina
GSK Investigational Site
Buenos Aires, Argentina
GSK Investigational Site
Capital Federal, Argentina
GSK Investigational Site
Pilar, Argentina
GSK Investigational Site
Rosario, Argentina
GSK Investigational Site
Aracaju, Brazil
GSK Investigational Site
Campinas, Brazil
GSK Investigational Site
Curitiba, Brazil
GSK Investigational Site
Manaus, Brazil
GSK Investigational Site
Porto Alegre, Brazil
GSK Investigational Site
Santa Maria, Brazil
GSK Investigational Site
São Paulo, Brazil
GSK Investigational Site
São Paulo, Brazil
GSK Investigational Site
Vila Mariana, Brazil
GSK Investigational Site
Sofia, Bulgaria
GSK Investigational Site
Sofia, Bulgaria
GSK Investigational Site
Sofia, Bulgaria
GSK Investigational Site
Veliko Tarnovo, Bulgaria
GSK Investigational Site
Vancouver, British Columbia, Canada
GSK Investigational Site
Victoria, British Columbia, Canada
GSK Investigational Site
Ottawa, Ontario, 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
Saint-Jérôme, Quebec, Canada
GSK Investigational Site
Beijing, China
GSK Investigational Site
Beijing, China
GSK Investigational Site
Beijing, China
GSK Investigational Site
Changchun, 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
Nanjing, China
GSK Investigational Site
Shanghai, China
GSK Investigational Site
Shanghai, China
GSK Investigational Site
Shanghai, China
GSK Investigational Site
Shenyang, China
GSK Investigational Site
Shenzhen, China
GSK Investigational Site
Ürümqi, China
GSK Investigational Site
Wuhan, China
GSK Investigational Site
Xi'an, China
GSK Investigational Site
Zhengzhou, China
GSK Investigational Site
Zhenjiang, China
GSK Investigational Site
Clermont-Ferrand, France
GSK Investigational Site
Clichy, France
GSK Investigational Site
Dijon, France
GSK Investigational Site
Lille, France
GSK Investigational Site
Pessac, France
GSK Investigational Site
Poitiers, France
GSK Investigational Site
Rennes, France
GSK Investigational Site
Strasbourg, France
GSK Investigational Site
Toulouse, France
GSK Investigational Site
Berlin, Germany
GSK Investigational Site
Berlin, Germany
GSK Investigational Site
Berlin, Germany
GSK Investigational Site
Berlin, Germany
GSK Investigational Site
Bochum, Germany
GSK Investigational Site
Cologne, Germany
GSK Investigational Site
Düsseldorf, Germany
GSK Investigational Site
München, Germany
GSK Investigational Site
Athens, Greece
GSK Investigational Site
Athens, Greece
GSK Investigational Site
Periohi Dragana Alexand, Greece
GSK Investigational Site
Rio Patras, Greece
GSK Investigational Site
Kowloon, Hong Kong
GSK Investigational Site
Pokfulam, Hong Kong
GSK Investigational Site
Shatin, Hong Kong
GSK Investigational Site
Budapest, Hungary
GSK Investigational Site
Eger, Hungary
GSK Investigational Site
Gyula, Hungary
GSK Investigational Site
Miskolc, Hungary
GSK Investigational Site
Belagavi, India
GSK Investigational Site
Chandigarh, India
GSK Investigational Site
Chennai, India
GSK Investigational Site
Coimbatore, India
GSK Investigational Site
Guhawati, India
GSK Investigational Site
Hyderabad, India
GSK Investigational Site
HyderabadTelangana, India
GSK Investigational Site
Jaipur, India
GSK Investigational Site
Ludhiana, India
GSK Investigational Site
Manipal, India
GSK Investigational Site
Mumbai, India
GSK Investigational Site
Mumbai, India
GSK Investigational Site
Mumbai, India
GSK Investigational Site
Pune, India
GSK Investigational Site
Surat, India
GSK Investigational Site
Brescia, Italy
GSK Investigational Site
Foggia, Italy
GSK Investigational Site
Messina, Italy
GSK Investigational Site
Milan, Italy
GSK Investigational Site
Milan, Italy
GSK Investigational Site
Modena, Italy
GSK Investigational Site
Chiba, Japan
GSK Investigational Site
Ehime, Japan
GSK Investigational Site
Fukuoka, Japan
GSK Investigational Site
Fukuoka, Japan
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
Hyōgo, Japan
GSK Investigational Site
Kumamoto, Japan
GSK Investigational Site
Miyagi, Japan
GSK Investigational Site
Tokyo, Japan
GSK Investigational Site
Tokyo, Japan
GSK Investigational Site
Tokyo, Japan
GSK Investigational Site
George Town, Malaysia
GSK Investigational Site
Johor Bahru, Malaysia
GSK Investigational Site
Kota Bharu Kelantan, Malaysia
GSK Investigational Site
Kota Kinabalu, Malaysia
GSK Investigational Site
Kuala Lumpur, Malaysia
GSK Investigational Site
Kuantan, Malaysia
GSK Investigational Site
Guadalajara, Mexico
GSK Investigational Site
Oaxaca City, Mexico
GSK Investigational Site
Panama City, Panama
GSK Investigational Site
Bytom, Poland
GSK Investigational Site
Krakow, Poland
GSK Investigational Site
Łańcut, Poland
GSK Investigational Site
Bucharest, Romania
GSK Investigational Site
Bucharest, Romania
GSK Investigational Site
Cluj-Napoca, Romania
GSK Investigational Site
Iași, Romania
GSK Investigational Site
Suceava, Romania
GSK Investigational Site
Timișoara, Romania
GSK Investigational Site
Singapore, Singapore
GSK Investigational Site
Singapore, Singapore
GSK Investigational Site
Ansan, South Korea
GSK Investigational Site
Busan, South Korea
GSK Investigational Site
Daegu, South Korea
GSK Investigational Site
Daegu, South Korea
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Seoul, South Korea
GSK Investigational Site
Barcelona, Spain
GSK Investigational Site
Barcelona, Spain
GSK Investigational Site
León, Spain
GSK Investigational Site
Madrid, Spain
GSK Investigational Site
Málaga, Spain
GSK Investigational Site
Salamanca, Spain
GSK Investigational Site
Santander, Spain
GSK Investigational Site
Valencia, Spain
GSK Investigational Site
Valladolid, Spain
GSK Investigational Site
Vigo, Spain
GSK Investigational Site
Kaohsiung City, Taiwan
GSK Investigational Site
Kaohsiung City, Taiwan
GSK Investigational Site
Taichung, Taiwan
GSK Investigational Site
Taipei, Taiwan
GSK Investigational Site
Tau-Yuan, Taiwan
GSK Investigational Site
Bangkok, Thailand
GSK Investigational Site
Ankara, Turkey (Türkiye)
GSK Investigational Site
Birmingham, United Kingdom
GSK Investigational Site
Edinburgh, United Kingdom
GSK Investigational Site
Leeds West Yorkshire, United Kingdom
GSK Investigational Site
London, United Kingdom
GSK Investigational Site
London, United Kingdom