NCT06537414

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

A Phase 2b, Multi-centre, Randomized, Partially Placebo-controlled, Double-blind Study to Investigate the Safety and Efficacy of Sequential Therapy With Daplusiran/Tomligisiran Followed by Bepirovirsen in Participants With Chronic Hepatitis B Virus on Background Nucleos(t)Ide Analogue Therapy (B-United)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 283 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Chronic Hepatitis B Virus Infection
• Hepatitis B

Interventions

Type	Name	Description
DRUG	Daplusiran/Tomligisiran Dose Level 1	Daplusiran/Tomligisiran dose level 1 will be administered
DRUG	Daplusiran/Tomligisiran Dose Level 2	Daplusiran/Tomligisiran dose level 2 will be administered
DRUG	Bepirovirsen	Bepirovirsen will be administered
DRUG	Placebo	Placebo will be administered

Timeline

• Start date: 2024-11-11
• Primary completion: 2027-05-31
• Completion: 2027-05-31
• First posted: 2024-08-05
• Last updated: 2025-07-28

Locations

81 sites across 19 countries: United States, Australia, Belgium, Brazil, Canada, China, France, Germany, Greece, Hong Kong, Italy, Japan, New Zealand, Singapore, South Africa, South Korea, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study