NCT04954859Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
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
Source: ClinicalTrials.gov · Last updated 5 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 366 (actual)
- First submitted
- 29 Jun 2021
- Start date
- 14 Dec 2021
- Primary completion date
- 24 Jan 2029
- Lead sponsor
- GlaxoSmithKline
- Diseases
- Hepatitis B
- NCT number
- NCT04954859
- EU CT number
- 2023-506867-33-01
- EudraCT number
- 2021-000554-26
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 366
- From 14 Dec 2021 to the primary completion date, 24 Jan 2029
- 146 sites in 29 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants who have/or are currently participating in another non-GSK interventional clinical study exploring HBV treatment since completing their treatment with bepirovirsen.
Other illness
- Any condition which, in the opinion of the investigator or Medical Monitor, contraindicates their participation in this study.
Who the study is looking for
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (146)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| - Coordinator of this site? Confirm its status | La Plata | Argentina | Unknown status |
| - Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| - Coordinator of this site? Confirm its status | Santa Fe | Argentina | Unknown status |
| - Coordinator of this site? Confirm its status | Fitzroy | Australia | Unknown status |
| - Coordinator of this site? Confirm its status | Herston | Australia | Unknown status |
| University Multiprofile Hospital For Active Treatment Saint Georgi EAD Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Active, not recruiting |
| Multiprofile Hospital For Active Treatment Hadji Dimitar OOD Coordinator of this site? Confirm its status | Sliven | Bulgaria | Active, not recruiting |
| Military Medical Academy Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Active, not recruiting |
| University Multiprofile Hospital For Active Treatment Sofiamed OOD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Active, not recruiting |
| Diagnostic-Consultative Center Alexandrovska EOOD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Active, not recruiting |
| Diagnostics-Consultancy Center Mladost M Varna OOD Coordinator of this site? Confirm its status | Varna | Bulgaria | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Aracaju | Brazil | Unknown status |
| - Coordinator of this site? Confirm its status | Campinas | Brazil | Unknown status |
| - Coordinator of this site? Confirm its status | Curitiba | Brazil | Unknown status |
| - Coordinator of this site? Confirm its status | Manaus | Brazil | Unknown status |
| - Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| - Coordinator of this site? Confirm its status | Vila Mariana | Brazil | Unknown status |
| - Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Victoria | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| - Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| - Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| - Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| - Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| - Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| - Coordinator of this site? Confirm its status | Kunming | China | Unknown status |
| - Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| - Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
| - Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| - Coordinator of this site? Confirm its status | Ürümqi | China | Unknown status |
| - Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| - Coordinator of this site? Confirm its status | Xiamen | China | Unknown status |
| - Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| - Coordinator of this site? Confirm its status | Zhenjiang | China | Unknown status |
| - Coordinator of this site? Confirm its status | Zunyi | China | Unknown status |
| Infektiologisches Zentrum Steglitz (IZS) Coordinator of this site? Confirm its status | Berlin | Germany | Active, not recruiting |
| Epimed Gesellschaft fuer epidemiologische und klinische Forschung in der Medizin mbH Coordinator of this site? Confirm its status | Berlin | Germany | Active, not recruiting |
| Universitaetsklinikum Duesseldorf AöR Coordinator of this site? Confirm its status | Duesseldorf | Germany | Active, not recruiting |
| Praxis MainFachArzt Coordinator of this site? Confirm its status | Frankfurt | Germany | Active, not recruiting |
| ICH Study Center Gmbh & Co. KG Coordinator of this site? Confirm its status | Hamburg | Germany | Active, not recruiting |
| Medizinische Hochschule Hannover Coordinator of this site? Confirm its status | Hanover | Germany | Active, not recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitario De Leon Coordinator of this site? Confirm its status | León | Spain | Active, not recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario de la Princesa Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Infanta Leonor Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Complexo Hospitalario Universitario de Pontevedra Coordinator of this site? Confirm its status | Pontevedra | Spain | Active, not recruiting |
| Parc Tauli Hospital Universitari Coordinator of this site? Confirm its status | Sabadell | Spain | Active, not recruiting |
| Hospital Universitario De Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Active, not recruiting |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Active, not recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Consorcio Hospital General Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Clichy | France | Active, not recruiting |
| Centre Hospitalier Intercommunal Créteil Coordinator of this site? Confirm its status | Créteil | France | Active, not recruiting |
| Hospices Civils De Lyon Coordinator of this site? Confirm its status | Lyon Cedex 04 | France | Active, not recruiting |
| Assistance Publique Hopitaux De Paris Coordinator of this site? Confirm its status | Paris Cedex 13 | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Pessac | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Rennes Coordinator of this site? Confirm its status | Rennes | France | Active, not recruiting |
| Les Hopitaux Universitaires De Strasbourg Coordinator of this site? Confirm its status | Strasbourg Cedex | France | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Cottingham | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Plymouth | United Kingdom | Unknown status |
| Evaggelismos Hospital Coordinator of this site? Confirm its status | Athens | Greece | Active, not recruiting |
| University General Hospital of Heraklion Coordinator of this site? Confirm its status | Heraklion | Greece | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Kowloon | Hong Kong SAR China | Unknown status |
| - Coordinator of this site? Confirm its status | Pokfulam | Hong Kong SAR China | Unknown status |
| Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet Coordinator of this site? Confirm its status | Budapest IX | Hungary | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Belagavi | India | Unknown status |
| - Coordinator of this site? Confirm its status | Coimbatore | India | Unknown status |
| - Coordinator of this site? Confirm its status | Hyderabad | India | Unknown status |
| - Coordinator of this site? Confirm its status | Kanchan Bagh Hyderabad | India | Unknown status |
| - Coordinator of this site? Confirm its status | Mumbai | India | Unknown status |
| - Coordinator of this site? Confirm its status | New Delhi | India | Unknown status |
| - Coordinator of this site? Confirm its status | Pune | India | Unknown status |
| - Coordinator of this site? Confirm its status | Surat | India | Unknown status |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII Coordinator of this site? Confirm its status | Bergamo | Italy | Active, not recruiting |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Active, not recruiting |
| ASST Fatebenefratelli Sacco Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Azienda Ospedaliero - Universitaria di Modena Coordinator of this site? Confirm its status | Modena | Italy | Active, not recruiting |
| Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli Coordinator of this site? Confirm its status | Naples | Italy | Active, not recruiting |
| Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Coordinator of this site? Confirm its status | Palermo | Italy | Active, not recruiting |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Active, not recruiting |
| Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino Coordinator of this site? Confirm its status | Turin | Italy | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Gifu | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Hiroshima | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Hokkaido | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Ishikawa | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Kagawa | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Kumamoto | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Miyagi | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Niigata | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Yamaguchi | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Ansan-si Gyenggi-do | South Korea | Unknown status |
| - Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| - Coordinator of this site? Confirm its status | Pusan | South Korea | Unknown status |
| - Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| - Coordinator of this site? Confirm its status | Kuala Terengganu | Malaysia | Unknown status |
| - Coordinator of this site? Confirm its status | Auckland | New Zealand | Unknown status |
| - Coordinator of this site? Confirm its status | Panama City | Panama | Unknown status |
| - Coordinator of this site? Confirm its status | Cebu City | Philippines | Unknown status |
| - Coordinator of this site? Confirm its status | Silang | Philippines | Unknown status |
| Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II Coordinator of this site? Confirm its status | Cracow | Poland | Active, not recruiting |
| Punkt Zdrowia Hlebowicz Jakubowski Lekarze sp. p. Coordinator of this site? Confirm its status | Gdansk | Poland | Active, not recruiting |
| Centrum Medyczne W Lancucie Sp. z o.o. Coordinator of this site? Confirm its status | Lancut | Poland | Active, not recruiting |
| HEPID Diagnostyka i Terapia Coordinator of this site? Confirm its status | Lublin | Poland | Active, not recruiting |
| ID Clinic Coordinator of this site? Confirm its status | Myslowice | Poland | Active, not recruiting |
| Spitalul Clinic De Boli Infectioase Si Tropicale Dr. Victor Babes Coordinator of this site? Confirm its status | Bucharest | Romania | Active, not recruiting |
| Institutul National de Boli Infectioase "Prof.Dr. Matei Bals" Coordinator of this site? Confirm its status | Bucharest | Romania | Active, not recruiting |
| Spitalul Clinic Colentina Bucuresti Coordinator of this site? Confirm its status | Bucharest | Romania | Active, not recruiting |
| Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr. Victor Babes Craiova Coordinator of this site? Confirm its status | Craiova | Romania | Active, not recruiting |
| Clinic Hospital For Infectious Diseases Sf. Cuvioasa Parascheva Galati Coordinator of this site? Confirm its status | Galati | Romania | Active, not recruiting |
| Spitalul Clinic De Boli Infectioase Sf. Parascheva Iasi Coordinator of this site? Confirm its status | Jassi | Romania | Active, not recruiting |
| Pelican Impex S.R.L. Coordinator of this site? Confirm its status | Oradea | Romania | Active, not recruiting |
| - Coordinator of this site? Confirm its status | Chelyabinsk | Russia | Unknown status |
| - Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| - Coordinator of this site? Confirm its status | Novosibirsk | Russia | Unknown status |
| - Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| - Coordinator of this site? Confirm its status | Samara | Russia | Unknown status |
| - Coordinator of this site? Confirm its status | Красноярск | Russia | Unknown status |
| - Coordinator of this site? Confirm its status | Singapore | Singapore | Unknown status |
| - Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| - Coordinator of this site? Confirm its status | Chiang Mai | Thailand | Unknown status |
| - Coordinator of this site? Confirm its status | Kho Hong Hat Yai | Thailand | Unknown status |
| - Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| - Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| - Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| - Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| - Coordinator of this site? Confirm its status | Taipei County | Taiwan | Unknown status |
| - Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Unknown status |
| - Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Colorado Springs | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| - Coordinator of this site? Confirm its status | San Jose | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Durban | South Africa | Unknown status |
| - Coordinator of this site? Confirm its status | Johannesburg | South Africa | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.