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NCT04954859 · ClinicalTrials.gov registry record · Phase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
A Phase 2 study of Hepatitis B, sponsored by GlaxoSmithKline.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 450
- Enrollment target
- 20
- Study locations
NCT04954859: Recruiting Phase 2 study of Hepatitis B, sponsored by GlaxoSmithKline.
NCT04954859 is a Phase 2 study of Hepatitis B that is actively recruiting participants, run by GlaxoSmithKline. The registered enrollment target is 450 participants, below the 1,614-participant average among 32 other Hepatitis B trials with a reported enrollment target (72% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04954859, a Phase 2 study of Hepatitis B, is actively recruiting participants, sponsored by GlaxoSmithKline.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 450 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
NA indicates nucleos(t)ide analogue (NA).
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 |
What NCT04954859 shows while recruiting
NCT04954859 is an interventional study that assigns participants to a tested intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap, below the 1,614-participant average among 32 other Hepatitis B trials with a reported enrollment target (72% lower).
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.
NCT04954859 names 20 study sites across 7 states, led by Other, California, Massachusetts.
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.
What interventions are being tested in trial NCT04954859?
The interventions under investigation include: Placebo (DRUG), Bepirovirsen (DRUG).
Who is sponsoring clinical trial NCT04954859?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Hepatitis B
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04954859's enrollment target sits among peer trials
450 10th of 32 higher than 23 of 32 other Hepatitis B trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatitis B trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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