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Clinical Trials List

Protocol Number206882

NCT Number(ClinicalTrials.gov Identfier)NCT04954859

Active

2024-12-01 - 2029-03-31

Phase II

Recruiting9

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
Trial scale

Multi-Regional Multi-Center
Update

2026/02/01

Investigators and Locations

Principal Investigator CHUNG-HSIN CHANG Digestive System Department

Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wen-Juei Jeng Digestive System Department

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chun-Jen Liu Digestive System Department

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 王鴻源 Digestive System Department

MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳建宏 Digestive System Department

Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 許耀峻 Digestive System Department

E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Cheng-Yuan Peng Digestive System Department

China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wan-Long Chuang Digestive System Department

Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ting-Tsung Chang

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Hepatitis B

Objectives

This trial will observe whether the clearance of viral material in the body and its effect in preventing relapse following prior treatment with bepirovirsen can be maintained long-term. Bepirovirsen or any other investigational drugs will not be provided or administered in this trial.

Test Drug

Injectable frozen powder

Active Ingredient

Bepirovirsen

Dosage Form

048

Dosage

150mg 1mg/ml

Endpoints

The primary objective of this trial was to characterize the long-term durability of treatment response in the following participants:

• Participants who did not receive NA and achieved the original primary outcome (PSPO)

• Participants who received NA/NA discontinued and achieved the original primary outcome (PSPO)

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

375 participants