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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
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506867-33-01
Acronym
206882
Enrollment
96
Registered
2024-02-28
Start date
2022-01-25
Completion date
Unknown
Last updated
2025-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B

Brief summary

For 209668 (B-Clear; not-on-NA): Time from achieving FC, to first occurrence of either HBsAg or HBV DNA reversion, or first use of any rescue medication., For 209668 (B-Clear; on-NA), 209348 (BTogether; on-NA), 212602 (B-Fine; on-NA), 202009 and 219288 (B-Well 1 & 2; on-NA)and 217023 (TH HBV ASO-001; on-NA): Time from achieving FC (24 weeks post NA cessation) to first occurrence of either HBsAg or HBV DNA reversion, or first use of any rescue medication, For 202009 and 219288 (B-Well 1 & 2; NAcessated): Time from achieving FC (including delayed FC) in the parent study to first occurrence of either HBsAg or HBV DNA reversion, or first use of any rescue medication.

Detailed description

For 209668 (B-Clear; on-NA), 209348 (BTogether; on-NA), 212602 (B-Fine; on-NA),217023 (TH HBV ASO-001; on-NA) and 202009 and 219288 (B-Well 1 & 2; on-NA): • Time from NA cessation to the first occurrence of HBsAg reversion or first use of any rescue medication, For 209668 (B-Clear; on-NA), 209348 (BTogether; on-NA), 212602 (B-Fine; on-NA),217023 (TH HBV ASO-001; on-NA) and 202009 and 219288 (B-Well 1 & 2; on-NA): Time from NA cessation to the first occurrence of virologic relapse or first use of any rescue medication, For 209668 (B-Clear; on-NA), 209348 (BTogether; on-NA), 212602 (B-Fine; on-NA),217023 (TH HBV ASO-001; on-NA) and 202009 and 219288 (B-Well 1 & 2; on-NA): Time from NA cessation to the first occurrence of clinical relapse or first use of any rescue medication, For 209668 (B-Clear; on-NA), 209348 (BTogether; on-NA), 212602 (B-Fine; on-NA),217023 (TH HBV ASO-001; on-NA) and 202009 and 219288 (B-Well 1 & 2; on-NA): Time from NA cessation to the first use of rescue medication, For 202009 and 219288 (B-Well 1 & 2; NAcessated): Time from NA cessation to the first occurrence of HBsAg reversion or first use of any rescue medication. Time from NA cessation to the first occurrence of virologic relapse or first use of any rescue medication., For 202009 and 219288 (B-Well 1 & 2; NAcessated): Time from NA cessation to the first occurrence of clinical relapse or first use of any rescue medication. Time from NA cessation to first use of any rescue medication., For 209668 (B-Clear; on-NA), 209348 (BTogether; on-NA), 212602 (B-Fine; on-NA): • Time from achieving complete response in the previous bepirovirsen treatment study, to first occurrence of either HBsAg or HBV DNA reversion, or first use of any rescue medication, 202009 and 219288 (B-Well 1 & 2; On-NA) and 217023 (TH HBV ASO-001; on-NA): •Time from HBsAg and HBV DNA , to first occurrence of either HBsAg or HBV DNA reversion, or first use of any rescue medication., For 209668 (B-Clear; not-on-NA) partial responders: a. Time from end of treatment in the parent study to delayed FC. b. For participants who go on to achieve delayed FC: Time from achieving delayed FC to loss of FC., For 202009 and 219288 (B-Well 1 & 2; NA-cessated) partial responders: a. Time from NA cessation to delayed FC. b. For participants who go on to achieve delayed FC: Time from achieving delayed FC to loss of FC., For 209668 (B-Clear; on-NA), 209348 (BTogether; on-NA), 212602 (B-Fine; on-NA), 202009 and 219288 (B-Well 1&2; on-NA), and 217023 (TH HBV ASO-001; on-NA): a. Time from NA cessation in B-Sure to delayed FC in B-Sure. b. For participants who achieve delayed FC in B-Sure: Time from achieving delayed FC to loss of FC., For 209668 (B-Clear; on-NA), 209348 (BTogether; on-NA), 212602 (B-Fine; on-NA), 217023 (TH HBV ASO-001; on-NA) and 202009 and 219288 (B-Well 1&2; on-NA): a.Time from end of treatment in the parent study to delayed complete response. b. For participants who achieve a delayed complete response: Time from achieving delayed complete response to loss of response., For 209668 (B-Clear; on-NA), 209348 (BTogether; on-NA), 212602 (B-Fine; on-NA), 202009 and 219288 (B-Well 1 & 2; on-NA) and 217023 (TH HBV ASO-001; on-NA): Time from NA cessation to HBsAg loss in the absence of any rescue medication., For 209668 (B-Clear; on-NA), 209348 (BTogether; on-NA), 212602 (B-Fine; on-NA), 202009 and 219288 (B-Well 1 & 2; on-NA) and 217023 (TH HBV ASO-001; on-NA): Time from NA cessation to the first occurrence of virologic relapse or first use of any rescue medication., For 209668 (B-Clear; on-NA), 209348 (BTogether; on-NA), 212602 (B-Fine; on-NA), 202009 and 219288 (B-Well 1 & 2; on-NA) and 217023 (TH HBV ASO-001; on-NA): Time from NA cessation to the first occurrence of clinical relapse or first use of any rescue medication, For 209668 (B-Clear; on-NA), 209348 (BTogether; on-NA), 212602 (B-Fine; on-NA), 202009 and 219288 (B-Well 1 & 2; on-NA) and 217023 (TH HBV ASO-001; on-NA): Time from NA cessation to the first use of rescue medication.

Interventions

None listed

Sponsors

Glaxosmithkline Research & Development Limited, Glaxosmithkline Research & Development Limited
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
For 209668 (B-Clear; not-on-NA): Time from achieving FC, to first occurrence of either HBsAg or HBV DNA reversion, or first use of any rescue medication., For 209668 (B-Clear; on-NA), 209348 (BTogether; on-NA), 212602 (B-Fine; on-NA), 202009 and 219288 (B-Well 1 & 2; on-NA)and 217023 (TH HBV ASO-001; on-NA): Time from achieving FC (24 weeks post NA cessation) to first occurrence of either HBsAg or HBV DNA reversion, or first use of any rescue medication, For 202009 and 219288 (B-Well 1 & 2; NAcessated): Time from achieving FC (including delayed FC) in the parent study to first occurrence of either HBsAg or HBV DNA reversion, or first use of any rescue medication.

Secondary

MeasureTime frame
For 209668 (B-Clear; on-NA), 209348 (BTogether; on-NA), 212602 (B-Fine; on-NA),217023 (TH HBV ASO-001; on-NA) and 202009 and 219288 (B-Well 1 & 2; on-NA): • Time from NA cessation to the first occurrence of HBsAg reversion or first use of any rescue medication, For 209668 (B-Clear; on-NA), 209348 (BTogether; on-NA), 212602 (B-Fine; on-NA),217023 (TH HBV ASO-001; on-NA) and 202009 and 219288 (B-Well 1 & 2; on-NA): Time from NA cessation to the first occurrence of virologic relapse or first use of any rescue medication, For 209668 (B-Clear; on-NA), 209348 (BTogether; on-NA), 212602 (B-Fine; on-NA),217023 (TH HBV ASO-001; on-NA) and 202009 and 219288 (B-Well 1 & 2; on-NA): Time from NA cessation to the first occurrence of clinical relapse or first use of any rescue medication, For 209668 (B-Clear; on-NA), 209348 (BTogether; on-NA), 212602 (B-Fine; on-NA),217023 (TH HBV ASO-001; on-NA) and 202009 and 219288 (B-Well 1 & 2; on-NA): Time from NA cessation to the first use of rescue medication

Countries

Bulgaria, France, Germany, Greece, Hungary, Italy, Poland, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026