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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: Active Phase 2 study of Hepatitis B and Chronic Hepatitis B Virus Infection, sponsored by GlaxoSmithKline.

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

The functional cure for HBV is defined as sustained suppression (24 weeks or longer) of HBV deoxyribonucleic acid (DNA) \<lower limit of quantification (LLOQ) and HBsAg not detected with or without HBsAb after a finite duration of therapy and off all HBV treatment. The number of participants achieving functional cure after discontinuation of all chronic HBV treatments (DAP/TOM, bepirovirsen, and NA treatment) will be reported.

Conditions Studied

Hepatitis B Chronic Hepatitis B Virus Infection

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

FieldValue
Enrollment Target 283 participants
Start Date 2024-11-11
Est. Completion 2027-05-31
Phase Phase 2
GlaxoSmithKline

1,345 total trials

What the registry record for NCT06537414 still lists

NCT06537414 is an interventional study that assigns participants to a tested intervention. The registered 283 participants enrollment target is mid-sized for trials with a published cap, below the 1,620-participant average among 32 other Hepatitis B trials with a reported enrollment target (83% lower).

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 names 20 study sites across 10 states, led by 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.

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 NCT06537414's enrollment target sits among peer trials

283 14th of 32 higher than 19 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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Related registry views

Source: ClinicalTrials.gov NCT06537414, the US trial registry maintained by the National Library of Medicine. NCT06537414 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.