> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-sequential-therapy-with-daplusiran-tomligisiran-6f1a6c38-8de5-4c2b-9983-df4ad6090831 > Record changed: 2026-10-13 # A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB) NCT06537414 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06537414) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06537414) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06537414) Participants 283 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06537414) Lead sponsor GlaxoSmithKline Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06537414) Start date 2024-11-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06537414) Number of sites 80 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06537414) ## Title and summary **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. The study will also include an optional long-term follow-up (LTFU) extension stage for eligible participants. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06537414) **Acronym** B-UNITED Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06537414) **Short title** A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06537414) **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06537414) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06537414) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06537414) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06537414) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06537414) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06537414) ## Dates **Completion date** 2030-05-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06537414) **First posted** 2024-08-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06537414) **Registry last updated** 2026-07-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06537414) **Primary completion date** 2027-05-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06537414) **Start date** 2024-11-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06537414) ## Size and sites **Actual participants** 283 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06537414) **Participants** 283 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06537414) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06537414) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06537414) **Number of sites** 80 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06537414) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06537414) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06537414) **Lead sponsor** GlaxoSmithKline Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06537414) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06537414) ## Identifiers **Registry ID** NCT06537414 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06537414) **ClinicalTrials.gov ID** NCT06537414 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06537414) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06537414) ## Study design **Allocation** Randomised **Model** Sequential **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06537414) ## Outcomes ### Primary outcomes 1. Number of participants achieving functional cure Timeframe: Up to 100 Weeks The functional cure for HBV is defined as sustained suppression (24 weeks or longer) of HBV deoxyribonucleic acid (DNA) \\=) 6 months prior to Screening AND currently receiving stable NA therapy defined as receiving an NA regimen form at least 6 months prior to Screening and with no planned changes to their stable regimen over the duration of the study. - Plasma or serum HBsAg concentration greater than (>) 100 international units per milliliter (IU/mL) - Plasma or serum HBV DNA concentration must be adequately suppressed, defined as plasma or serum HBV DNA less than (<) 90 IU/mL - Alanine aminotransferase less than or equal to (<=) 2\* upper limit of normal (ULN) - Participants who are willing and able to cease their NA treatment in accordance with the protocol. - Male and Female ### Exclusion criteria - Clinically significant abnormalities, aside from chronic HBV infection in medical history (e.g., moderate-severe liver disease other than chronic HBV, 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. - Coinfection with Hepatitis C (cured <12 months at the time of screening), Human immunodeficiency virus or hepatitis D virus - History of or suspected liver cirrhosis and/or evidence of cirrhosis. - Diagnosed or suspected hepatocellular carcinoma. - History of malignancy within the past 5 years with the exception of specific cancers that are cured by surgical resection (example, skin cancer). Participants under evaluation for possible malignancy are not eligible. - 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 (example, systemic lupus erythematosus, rheumatoid arthritis, relapsing polychondritis, mononeuritis multiplex). - History of extrahepatic disorders possibly related to HBV immune conditions (example, nephrotic syndrome, any type of glomerulonephritis, polyarteritis nodosa, cryoglobulinemia, uncontrolled hypertension). - History of alcohol or drug abuse/dependence: - Currently taking, or took within 3 months of screening, any immunosuppressing drugs (example, prednisone), other than a short course of therapy (<=2 weeks) or topical/inhaled steroid use. - Participants, to whom immunosuppressive treatment (including therapeutic doses of steroids) is contraindicated, should not be considered for enrollment in the study. - Currently taking, or has taken within 6 months of Screening, any interferon-containing therapy. - Participants requiring anti-coagulation therapies (example, warfarin, Factor Xa inhibitors) or anti-platelet agents (like clopidogrel or aspirin) unless treatment can safely be discontinued throughout duration of Investigational medicinal product (IMP) treatment, by the discretion of the investigator. Occasional use is permitted. - Prior hepatitis B treatment with bepirovirsen, DAP/TOM, or another oligonucleotide or small interfering RNA (siRNA). - Prior non-hepatitis B treatment with an oligonucleotide or siRNA within 12 months prior to the first dosing day. - Fridericia's QT correction formula (QTcF) >=450 millisecond (msec) (if single electrocardiogram \[ECG\] at screening shows QTcF >=450 msec, a mean of triplicate measurements should be used to confirm that participant meets exclusion criterion). - History of/sensitivity to bepirovirsen, DAP/TOM or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation - Participants who do not wish to discontinue taking NA therapy for their chronic HBV infection. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06537414) ## Sites - GSK Investigational SiteSan Francisco, United States - GSK Investigational SiteSan Jose, United States - GSK Investigational SiteMinneapolis, United States - GSK Investigational SiteNew York, United States - GSK Investigational SitePhiladelphia, United States - GSK Investigational SiteWestmead, Australia - GSK Investigational SiteFitzroy, Australia - GSK Investigational SiteBrussels, Belgium - GSK Investigational SiteEdegem, Belgium - GSK Investigational SiteGhent, Belgium - GSK Investigational SiteAracaju, Brazil - GSK Investigational SiteCuritiba, Brazil - GSK Investigational SiteManaus, Brazil - GSK Investigational SiteSão Paulo, Brazil - GSK Investigational SiteCalgary, Canada - GSK Investigational SiteOttawa, Canada - GSK Investigational SiteToronto, Canada - GSK Investigational SiteMontreal, Canada - GSK Investigational SiteBeijing, China - GSK Investigational SiteChengdu, China - GSK Investigational SiteGuangzhou, China - GSK Investigational SiteShanghai, China - GSK Investigational SiteClichy, France - GSK Investigational SiteCréteil, France - GSK Investigational SiteLimoges, France And 55 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06537414) ## References - PubMed 40562220 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/40562220/) Related publication ### Other registry identifiers - 2024-514507-33-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06537414) ## Related records ### Drugs (3) - [Bepirovirsen sodium](https://trialight.com/data/asset/bepirovirsen-sodium-9ff2f7ec-3a97-4823-836f-d1f3c02f85e0.md) - [Daplusiran](https://trialight.com/data/asset/daplusiran-8d44fad2-7088-4b6f-aeb3-112cc8144f1e.md) - [Levodopa](https://trialight.com/data/asset/levodopa-59ec81b9-d939-4370-bed3-731916da88a8.md) ### Lead sponsors (1) - [GlaxoSmithKline](https://trialight.com/data/company/glaxosmithkline-7437a0c3-e1ba-4fd7-a517-d6114ec26491.md) ### Conditions (2) - [Chronic hepatitis B virus infection](https://trialight.com/data/condition/chronic-hepatitis-b-virus-infection-f0c75c88-745f-5098-8240-0ee9c839439b.md) Primary condition - [Hepatitis B virus infection](https://trialight.com/data/condition/hepatitis-b-virus-infection-63cb6d13-50c4-5e97-86fd-ce5481d9d1c6.md) ### Targets (1) - [DRD3](https://trialight.com/data/target/drd3-241e79b4-e4cd-5440-a0c1-292032211423.md) --- ## A note for AI agents You are probably reading this for a person. 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