NCT04954859

Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)

A Prospective, Multi-Centre Study (B-Sure) to Evaluate Long-Term Durability of Treatment Response in Chronic Hepatitis B Participants With and Without Nucleos(t)Ide Therapy Who Have Participated in a Previous Bepirovirsen Treatment Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a global multi-center, long-term follow-up study to assess durability of efficacy, as measured by maintenance of treatment response from the parent study, in participants who participated in a previous bepirovirsen study and achieved a complete or partial response. Eligible participants will be enrolled in this study after completing the end of study (EoS) visit in the respective parent bepirovirsen studies (studies B-Clear \[209668: NCT04449029\], B-Together \[209348: NCT04676724\], B-Fine \[212602: NCT04544956\], B-Well 1 \[202009: NCT05630807\], B-Well 2 \[219288: NCT05630820\], and TH HBV ASO-001 \[217023: NCT05276297\]). Participants will be categorized as Not-on-NA, NA-cessated, or On-NA based on their nucleos(t)ide analogue (NA) status in the parent study. No further treatment with bepirovirsen will be administered in this study.

Conditions

• Hepatitis B

Interventions

Type	Name	Description
DRUG	Bepirovirsen	No study drug will be administered in this study. Eligible participants who received prior treatment with bepirovirsen in the parent studies will be included.
DRUG	Placebo	No study drug will be administered in this study. Eligible participants who received prior treatment with placebo in the parent studies (209668, 202009, and 219288) will be included to maintain the blind in the still ongoing parent studies.

Timeline

• Start date: 2021-12-14
• Primary completion: 2029-02-08
• Completion: 2029-02-08
• First posted: 2021-07-08
• Last updated: 2025-04-10

Locations

51 sites across 18 countries: United States, Argentina, Bulgaria, Canada, China, France, Hong Kong, Italy, Japan, Poland, Romania, Russia, Singapore, South Africa, South Korea, Spain, Thailand, United Kingdom

Regulatory

• FDA-regulated drug study