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NCT06537414 · ClinicalTrials.gov registry record · Phase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
A Phase 2 study of Hepatitis B and Chronic Hepatitis B Virus Infection, sponsored by GlaxoSmithKline.
- Active
- Registry status
- Phase 2
- Development phase
- 283
- Enrollment target
- 20
- Study locations
NCT06537414 is a Phase 2 study of Hepatitis B and Chronic Hepatitis B Virus Infection that is active but no longer recruiting, run by GlaxoSmithKline. The registered enrollment target is 283 participants, below the 1,620-participant average among 32 other Hepatitis B trials with a reported enrollment target (83% lower). The trial reports 20 study locations across 10 states.
The verdict
NCT06537414, a Phase 2 study of Hepatitis B and Chronic Hepatitis B Virus Infection, is active but no longer recruiting, sponsored by GlaxoSmithKline.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 283 participants
- Enrollment target
- 20
- Study locations
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, categorized as Phase 2. The registered enrollment target is 283 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,620-participant average among 32 other Hepatitis B trials with a reported enrollment target (83% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
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.
NCT06537414 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Other, California, Ontario.
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.
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).
Who is sponsoring clinical trial NCT06537414?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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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