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NCT06497504 · ClinicalTrials.gov registry record · Phase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
A Phase 2 study of Hepatitis B, sponsored by GlaxoSmithKline.
- Active
- Registry status
- Phase 2
- Development phase
- 157
- Enrollment target
- 20
- Study locations
NCT06497504: Active Phase 2 study of Hepatitis B, sponsored by GlaxoSmithKline.
NCT06497504 is a Phase 2 study of Hepatitis B that is active but no longer recruiting, run by GlaxoSmithKline. The registered enrollment target is 157 participants, below the 1,624-participant average among 32 other Hepatitis B trials with a reported enrollment target (90% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06497504, a Phase 2 study of Hepatitis B, is active but no longer recruiting, sponsored by GlaxoSmithKline.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 157 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate the efficacy and safety of bepirovirsen compared to placebo in participants with human immunodeficiency virus (HIV)/hepatitis B virus (HBV) co-infection.
Primary Outcome
HBV virologic response defined as HBV surface antigen (HBsAg) not detected and HBV deoxyribonucleic acid (DNA) less than (\<) lower limit of quantification (LLOQ).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Bepirovirsen
Study Locations (20)
Other
- GSK Investigational Site - Almagro
- GSK Investigational Site - Buenos Aires
- GSK Investigational Site - Buenos Aires
- GSK Investigational Site - Buenos Aires
- GSK Investigational Site - La Plata
- GSK Investigational Site - Rosario
- GSK Investigational Site - Aracaju
- GSK Investigational Site - Campinas
- GSK Investigational Site - Curitiba
- GSK Investigational Site - Manaus
- GSK Investigational Site - Salvador
- GSK Investigational Site - São Paulo
California
- GSK Investigational Site - Bakersfield
- GSK Investigational Site - San Francisco
Florida
- GSK Investigational Site - Orlando
- GSK Investigational Site - West Palm Beach
Maryland
- GSK Investigational Site - Baltimore
Minnesota
- GSK Investigational Site - Minneapolis
New Jersey
- GSK Investigational Site - Hillsborough
Ontario
- GSK Investigational Site - Ottawa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 157 participants |
| Start Date | 2024-09-17 |
| Est. Completion | 2027-04-22 |
| Phase | Phase 2 |
What the registry record for NCT06497504 still lists
NCT06497504 is an interventional study that assigns participants to a tested intervention. The registered 157 participants enrollment target is mid-sized for trials with a published cap, below the 1,624-participant average among 32 other Hepatitis B trials with a reported enrollment target (90% 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.
NCT06497504 names 20 study sites across 7 states, led by Other, California, Florida.
Frequently Asked Questions
What is clinical trial NCT06497504 about?
NCT06497504 is a clinical study titled "Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)". This study will evaluate the efficacy and safety of bepirovirsen compared to placebo in participants with human immunodeficiency virus (HIV)/hepatitis B virus (HBV) co-infection.
What is the current status of trial NCT06497504?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 157 participants. The study started on 2024-09-17. Estimated completion is 2027-04-22.
What conditions does trial NCT06497504 study?
This clinical trial studies the following conditions: Hepatitis B.
What interventions are being tested in trial NCT06497504?
The interventions under investigation include: Placebo (DRUG), Bepirovirsen (DRUG).
Who is sponsoring clinical trial NCT06497504?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06497504 being conducted?
This trial has 20 study locations across California, Florida, Maryland, Minnesota, New Jersey. 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 NCT06497504's enrollment target sits among peer trials
157 19th of 32 higher than 14 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
-
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
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-
Pentavalent DTaP-Hep B-IPV
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-
Study of Adding Entecavir to Current Lamivudine Therapy in HIV and HBV Co-Infected Patients
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