Clinical Research Directory

B-Ensure: Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants

Sponsor: GlaxoSmithKline

Summary

This multi-country, longitudinal follow-up study will enrol adults with chronic hepatitis B (CHB) who previously participated in the Phase III B-Well-1 ((202009: NCT05630807) or B-Well-2 (219288: NCT05630820) studies, received 24 weeks of Bepirovirsen treatment, and achieved hepatitis B surface antigen (HBsAg) levels less than or equal to (\<=) 100 International units per millilitres (IU/mL) at Week 72 without achieving functional cure. No investigational treatment will be administered in this study. Participants will be followed approximately every 6 months for up to 4 years, and retrospective data will be collected from Week 72 of the parent study until enrolment. The study aims to evaluate the long-term durability of HBsAg suppression and disease-related outcomes. The study will end at the last visit of the last participant globally (Month 48). The primary objective of the study is to describe the long-term durability of HBsAg reduction in participants who achieved HBsAg levels ≤100 IU/mL at Week 72 following 24 weeks of Bepirovirsen treatment.

Official title: B-Ensure: A Multi-centre, Prospective and Retrospective Study to Evaluate the Long-term Durability of Treatment Response in Participants With Chronic Hepatitis B Who Have Participated in a Previous Bepirovirsen Treatment Study

Key Details

Conditions

Interventions