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Clinical Trials List

Protocol Number206882

NCT Number(ClinicalTrials.gov Identfier)NCT04954859

Active

2024-12-01 - 2029-03-31

Phase II

Recruiting6

ICD-10B18.1

Chronic viral hepatitis B without delta-agent

ICD-9070.22

Viral hepatitis B with hepatic coma, chronic, without mention of hepatitis delta

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

Trial Applicant

Syneos Health
Sponsor

GlaxoSmithKline Research & Development Limited (GSK)
Trial scale

Multi-Regional Multi-Center
Update

2026/05/12

Investigators and Locations

Principal Investigator Cheng-Yuan Peng 無

China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 王鴻源無

MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wan-Long Chuang 無

Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 許耀峻無

E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wen-Juei Jeng

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chun-Jen Liu

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Chronic Hepatitis B

Objectives

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.

Test Drug

NA

Active Ingredient

NA

Dosage Form

NA

Dosage

NA

Endpoints

Percentage of Not-on-NA participants without loss of parent study primary outcome (PSPO)
Percentage of On-NA and NA-cessated participants with PSPO in the parent study who have hepatitis B surface antigen (HBsAg) reversion or use of any rescue medication after NA cessation (in either parent study or study 206682)

Inclution Criteria

Inclusion criteria:

Participants who enter the study on stable NA are willing and able to cease their NA treatment in accordance with the NA cessation schedule.
Capable of giving informed consent.
For participants rolling over from 209668 (B-Clear), 209348 (B-Together), and 212602 (B-Fine):

Participants who have previously received at least one dose of bepirovirsen AND

Achieved the PSPO in the parent study and who maintained a response until the End of Study (EoS) visit in their parent study (defined as complete responders to bepirovirsen from the parent study) OR
Demonstrated hepatitis B virus surface antigen (HBsAg) reduction greater than or equal to (≥) 1.0 log10 international units per milliliter (IU/mL) from parent study Baseline with HBsAg levels less than (<) 100 IU/mL and HBV deoxyribonucleic acid (DNA) < lower limit of quantification (LLOQ) for 24 weeks after the actual end of treatment regimen, in the absence of rescue medication and maintained until their EoS visit in the parent study.
For participants rolling over from 202009 (B-Well1) and 219288 (B-Well 2):

Participants who have previously received at least 1 dose of bepirovirsen (or matching placebo where appropriate) AND

NA cessated at Week 48 in parent study and achieved at least HBsAg <1 IU/ml and HBV DNA Achieved NA cessation criteria at Week 48 in parent study but have not stopped NA treatment, and are maintaining at least HBsAg <1 IU/ml and HBV DNA Did not achieve NA cessation criteria in parent study but achieved at least HBsAg <1 IU/ml and HBV DNA For participants rolling over from 217023 (TH HBV ASO-001):

Participants who have previously received at least 1 dose of bepirovirsen AND

Achieved HBsAg <1 IU/ml and HBV DNA Did not achieve HBsAg <1 IU/ml and HBV DNA

Exclusion Criteria

Exclusion Criteria:

Participants who have/or are currently participating in another non-GSK interventional clinical study exploring HBV treatment since completing their treatment with bepirovirsen.
Any condition which, in the opinion of the investigator or Medical Monitor, contraindicates their participation in this study.

The Estimated Number of Participants

Taiwan

19 participants
Global

450 participants