drugset / Trial / NCT06537414

A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)

NCT06537414

Phase 2 Active not recruiting 283 enrolled GlaxoSmithKline
RandomizedSequentialDouble-blindTreatment

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. The study will also include an optional long-term follow-up (LTFU) extension stage for eligible participants.

Timeline

Start
2024-11-11
Primary completion
2027-05-31
Completion
2030-05-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Bepirovirsen Antisense oligonucleotide
Subject Daplusiran Unknown
Subject Tomligisiran Unknown