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A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
NCT06537414 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Bepirovirsen
- DRUG Daplusiran/Tomligisiran Dose Level 1
- DRUG Daplusiran/Tomligisiran Dose Level 2
Study Locations (20)
Other
- GSK Investigational Site — Brussels
- GSK Investigational Site — Edegem
- GSK Investigational Site — Ghent
- GSK Investigational Site — Aracaju
- GSK Investigational Site — Curitiba
- GSK Investigational Site — Manaus
- GSK Investigational Site — São Paulo
- GSK Investigational Site — Beijing
- GSK Investigational Site — Chengdu
California
- GSK Investigational Site — San Francisco
- GSK Investigational Site — San Jose
Ontario
- GSK Investigational Site — Ottawa
- GSK Investigational Site — Toronto
Minnesota
- GSK Investigational Site — Minneapolis
New York
- GSK Investigational Site — New York
Pennsylvania
- GSK Investigational Site — Philadelphia
New South Wales
- GSK Investigational Site — Westmead
Victoria
- GSK Investigational Site — Fitzroy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 283 participants |
| Start Date | 2024-11-11 |
| Est. Completion | 2027-05-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06537414
The ClinicalTrials.gov registry entry for NCT06537414 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 283 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Hepatitis B appearing as the primary indexed condition, and to 4 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06537414 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Other, California, Ontario. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06537414 about?
NCT06537414 is a clinical study titled "A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)". 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 bepirovirs...
What is the current status of trial NCT06537414?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 283 participants. The study started on 2024-11-11. Estimated completion is 2027-05-31.
What conditions does trial NCT06537414 study?
This clinical trial studies the following conditions: Hepatitis B, Chronic Hepatitis B Virus Infection. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06537414?
The interventions under investigation include: Placebo (DRUG), Bepirovirsen (DRUG), Daplusiran/Tomligisiran Dose Level 1 (DRUG), Daplusiran/Tomligisiran Dose Level 2 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06537414?
This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06537414 being conducted?
This trial has 20 study locations across California, Minnesota, New York, Pennsylvania, New South Wales. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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