Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
NCT ID: NCT06497504
Last Updated: 2025-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
150 participants
INTERVENTIONAL
2024-09-17
2027-04-27
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 2)
NCT05630820
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
NCT06537414
Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 1)
NCT05630807
Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and PEG-IFNα Combination Therapy in Chronic HBV Patients
NCT05970289
Study to Investigate the Safety and Efficacy of BRII-835 and BRII-179 Combination Therapy Treating Chronic Hepatitis B Virus (HBV) Infection
NCT04749368
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Participants receiving Bepirovirsen
Participants will receive bepirovirsen.
Bepirovirsen
Bepirovirsen will be administered.
Participants receiving Placebo
Participants will receive placebo.
Placebo
Placebo will be administered.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Bepirovirsen
Bepirovirsen will be administered.
Placebo
Placebo will be administered.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Must be on uninterrupted antiretroviral therapy (ART) containing at least tenofovir disoproxil (TDF) or tenofovir alafenamide (TAF) plus lamivudine (3TC) or emtricitabine (FTC) for greater than (\>)12 months, with no planned changes to the stable regimen over the duration of the study.
o Switch in ART is permitted \>=6 months prior to Screening for reasons not related to loss of HIV or HBV control (e.g., change in formulary, tolerability, side effects).
3. Documented evidence of at least 2 plasma HIV-1 ribonucleic acid (RNA) measurements less than (\<) 50 copies per milliliter (copies/mL) are required in the 12 months prior to Screening: 1 within 6 to 12 months prior to Screening and 1 within 6 months prior to Screening.
4. Plasma or serum HBV deoxyribonucleic acid (DNA) concentration must be adequately suppressed, defined as plasma or serum HBV DNA \<90 international units per milliliter (IU/mL).
5. Plasma or serum HBsAg concentration \>100 IU/mL and \<=3000 IU/mL.
6. Plasma HIV-1 RNA concentration must be undetectable, defined as plasma HIV 1 RNA \<50 copies/mL.
7. Cluster of differentiation 4 (CD4) count \>=350 cells per cubic millimeter (cells/mm\^3).
8. Alanine aminotransferase (ALT) \<=2 times upper limit of normal (ULN).
Exclusion Criteria
2. Diagnosed or suspected hepatocellular carcinoma (HCC).
3. History of extrahepatic disorders possibly related to HBV immune conditions (e.g., nephrotic syndrome, any type of glomerulonephritis, polyarteritis nodosa, cryoglobulinemia, uncontrolled hypertension).
4. Coinfection with:
1. Hepatitis C virus (HCV) with positive HCV antibody and detectable HCV RNA at Screening.
I. HCV treatment should have completed \>12 months prior to Screening.
2. Hepatitis D virus (HDV) defined as positive or equivocal HDV antibody regardless of HDV RNA level.
5. Clinically significant abnormalities, aside from HIV-1 infection and chronic HBV infection in medical history (e.g., moderate severe liver disease other than chronic HBV/HIV, acute coronary syndrome within 6 months of Screening, major surgery within 3 months of Screening, significant/unstable cardiac disease, uncontrolled diabetes, bleeding diathesis coagulopathy) or clinically significant physical examination findings.
6. Untreated syphilis infection (positive rapid plasma reagin \[RPR\] at Screening without clear documentation of treatment) are excluded unless they complete treatment during the Screening period and 7 days prior to randomization.
7. History of malignancy within the past 5 years with the exception of specific cancers that are cured by surgical resection (e.g., skin cancer). Participants under evaluation for possible malignancy are not eligible.
8. History of vasculitis or presence of symptoms and signs of potential vasculitis (e.g., vasculitic rash, skin ulceration, repeated blood detected in urine without identified cause), current or history of an autoimmune condition or history/presence of other diseases that may be associated with vasculitis condition (e.g., systemic lupus erythematosus, rheumatoid arthritis, relapsing polychondritis, mononeuritis multiplex).
9. Participants who in the investigator's judgment, have a significant risk of suicide or self-harm.
10. Alcohol or drug abuse/dependence
11. Currently taking, or took within 3 months of Screening, any immunosuppressing drugs (e.g., prednisone), other than a short course of therapy (\<=2 weeks) or topical/inhaled steroid use.
12. Participants to whom immunosuppressive treatment, including therapeutic doses of steroids, is contraindicated should not be considered for enrolment in the study.
13. Currently taking, or has taken within 12 months of Screening, any interferon containing therapy.
14. Participants requiring anti coagulation therapies (e.g., warfarin, Factor Xa inhibitors) or anti platelet agents (including but not limited to clopidogrel or aspirin) unless treatment can safely be discontinued throughout duration of study intervention, by the discretion of the investigator. Occasional use is permitted.
15. Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.
16. Prior treatment with any oligonucleotide or small interfering ribonucleic acid (siRNA) within 12 months prior to the first dosing day.
17. Prior treatment with bepirovirsen.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
GlaxoSmithKline
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
GSK Investigational Site
Bakersfield, California, United States
GSK Investigational Site
San Francisco, California, United States
GSK Investigational Site
Orlando, Florida, United States
GSK Investigational Site
West Palm Beach, Florida, United States
GSK Investigational Site
Baltimore, Maryland, United States
GSK Investigational Site
Minneapolis, Minnesota, United States
GSK Investigational Site
Hillsborough, New Jersey, United States
GSK Investigational Site
Almagro, , Argentina
GSK Investigational Site
Buenos Aires, , Argentina
GSK Investigational Site
Buenos Aires, , Argentina
GSK Investigational Site
Buenos Aires, , Argentina
GSK Investigational Site
La Plata, , 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
Salvador, , Brazil
GSK Investigational Site
São Paulo, , Brazil
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
Marseille, , France
GSK Investigational Site
Melun, , France
GSK Investigational Site
Montpellier, , France
GSK Investigational Site
Nantes, , France
GSK Investigational Site
Paris, , France
GSK Investigational Site
Paris, , France
GSK Investigational Site
Florence, , Italy
GSK Investigational Site
Genova, , Italy
GSK Investigational Site
Milan, , Italy
GSK Investigational Site
Milan, , Italy
GSK Investigational Site
Napoli, , Italy
GSK Investigational Site
Roma, , Italy
GSK Investigational Site
Sassari, , Italy
GSK Investigational Site
Durban, , South Africa
GSK Investigational Site
Johannesburg, , South Africa
GSK Investigational Site
Reiger Park, , South Africa
GSK Investigational Site
Barcelona, , Spain
GSK Investigational Site
Córdoba, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Banchiau Taipei, , Taiwan
GSK Investigational Site
Kaohsiung City, , Taiwan
GSK Investigational Site
Bristol Avon, , United Kingdom
GSK Investigational Site
London, , United Kingdom
GSK Investigational Site
London, , United Kingdom
GSK Investigational Site
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-509588-25
Identifier Type: OTHER
Identifier Source: secondary_id
219231
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.