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Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
NCT04954859 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Bepirovirsen
Study Locations (20)
Other
- GSK Investigational Site — Buenos Aires
- GSK Investigational Site — Sliven
- GSK Investigational Site — Sofia
- GSK Investigational Site — Hangzhou
- GSK Investigational Site — Shanghai
- GSK Investigational Site — Wuhan
- GSK Investigational Site — Clichy
- GSK Investigational Site — Strasbourg
- GSK Investigational Site — Pokfulam
- GSK Investigational Site — Milan
- GSK Investigational Site — Milan
- GSK Investigational Site — Modena
- GSK Investigational Site — Hiroshima
- GSK Investigational Site — Hiroshima
California
- GSK Investigational Site — Sacramento
Massachusetts
- GSK Investigational Site — Boston
Michigan
- GSK Investigational Site — Detroit
Alberta
- GSK Investigational Site — Calgary
British Columbia
- GSK Investigational Site — Victoria
Ontario
- GSK Investigational Site — Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2021-12-14 |
| Est. Completion | 2029-02-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04954859
The ClinicalTrials.gov registry entry for NCT04954859 describes a study currently listed as 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 450 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 1 condition, with Hepatitis B appearing as the primary indexed condition, and to 2 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: NCT04954859 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Other, California, Massachusetts. 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 NCT04954859 about?
NCT04954859 is a clinical study titled "Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)". 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...
What is the current status of trial NCT04954859?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 450 participants. The study started on 2021-12-14. Estimated completion is 2029-02-08.
What conditions does trial NCT04954859 study?
This clinical trial studies the following conditions: Hepatitis B. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04954859?
The interventions under investigation include: Placebo (DRUG), Bepirovirsen (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04954859?
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 NCT04954859 being conducted?
This trial has 20 study locations across California, Massachusetts, Michigan, Alberta, British Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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