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Active Not Recruiting
NCT06537414
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Conditions: Chronic Hepatitis B Virus Infection, Hepatitis B
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 283
Sponsor: GlaxoSmithKline
Location: GSK Investigational Site San Francisco California
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.
Eligibility Criteria
Inclusion Criteria:
* Age: At least 18 years of age at the time of signing the informed consent
* Documented chronic HBV infection greater than or equal to (\>=) 6 months prior to Screening AND currently receiving stable NA therapy defined as receiving an NA regimen form at least 6 months prior to Screening and with no planned changes to their stable regimen over the duration of the study.
* Plasma or serum HBsAg concentration greater than (\>) 100 international units per milliliter (IU/mL)
* Plasma or serum HBV DNA concentration must be adequately suppressed, defined as plasma or serum HBV DNA less than (\
Source: ClinicalTrials.gov (NCT06537414). StuddyBuddy aggregates publicly available trial information.