Long-term Follow-up Study to Evaluate Durability of Sustained Virologic Response (SVR) in Previous GSK3228836 Study Participants (B-Sure)

Phase 2

Recruiting

• Conditions: Hepatitis B
• Interventions: Drug: Bepirovirsen; Drug: Placebo

• Registration Number: NCT04954859
• Lead Sponsor: GlaxoSmithKline

Brief Summary

This is a long-term follow-up study to assess durability of efficacy, as measured by SVR, in participants who have received prior treatment with GSK3228836 and achieved a complete or partial response. No further treatment with GSK3228836 will be administered in this study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-29
• Study First Submitted QC: 2021-06-29
• Study First Posted: 2021-07-08
• Study Start: 2021-12-14
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-10
• Primary Completion: 2029-02-08
• Study Completion: 2029-02-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

Not provided

Exclusion Criteria

• Participants who have/or are currently participating in another non-GSK interventional clinical study exploring HBV treatment since completing their treatment with GSK3228836.
• Any condition which, in the opinion of the investigator or Medical Monitor, contraindicates their participation in this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NA-cessated participants	Bepirovirsen	Participants rolling over from studies 202009 and 219288 who have stopped NA treatment during the parent study will be included in this arm. Participants will be followed up for 33 months. No study treatment will be administered in this study.
Not-on-NA participants	Bepirovirsen	Participants rolling over from study 209668 who have not received nucleos(t)ide analogue (NA) therapy during the parent study and remain off NAs will be included in this arm. Participants will be followed up for 33 months. Participants maintaining either functional cure (FC) or a partial response off NA treatment at Month 33 will be eligible to be followed up for an additional 2 years. No study treatment will be administered in this study.
Not-on-NA participants	Placebo	Participants rolling over from study 209668 who have not received nucleos(t)ide analogue (NA) therapy during the parent study and remain off NAs will be included in this arm. Participants will be followed up for 33 months. Participants maintaining either functional cure (FC) or a partial response off NA treatment at Month 33 will be eligible to be followed up for an additional 2 years. No study treatment will be administered in this study.
On-NA participants	Bepirovirsen	Participants rolling over from studies 209668, 209348, 212602, 202009, 219288, and 217023 who entered the parent study on stable NA therapy and remained on NA therapy for the duration of the treatment and follow-up periods in the parent study will be included in this arm. NA cessation will occur at 3 months in 206882 for eligible and willing participants. Participants will be followed up for 33 months. Participants rolling over from studies 209668 and 209348 who stopped NA treatment and are maintaining either FC or a partial response at Month 33, and remaining off NA treatment, will be eligible to be followed up for an additional 2 years. No study treatment will be administered in this study.
On-NA participants	Placebo	Participants rolling over from studies 209668, 209348, 212602, 202009, 219288, and 217023 who entered the parent study on stable NA therapy and remained on NA therapy for the duration of the treatment and follow-up periods in the parent study will be included in this arm. NA cessation will occur at 3 months in 206882 for eligible and willing participants. Participants will be followed up for 33 months. Participants rolling over from studies 209668 and 209348 who stopped NA treatment and are maintaining either FC or a partial response at Month 33, and remaining off NA treatment, will be eligible to be followed up for an additional 2 years. No study treatment will be administered in this study.
NA-cessated participants	Placebo	Participants rolling over from studies 202009 and 219288 who have stopped NA treatment during the parent study will be included in this arm. Participants will be followed up for 33 months. No study treatment will be administered in this study.

Primary Outcome Measures

Name	Time	Method
Percentage of Not-on-NA participants without loss of parent study primary outcome (PSPO)	From primary endpoint assessment in the parent study up to Month 57	NA indicates nucleos(t)ide analogue (NA).
Percentage of On-NA participants rolling over from studies 209668 and 209348 without loss of functional cure (FC) after NA-cessation in study 206882	From Month 3 up to Month 57
Percentage of NA-cessated participants rolling over from studies 202009 and 219288 without loss of FC after NA-cessation in the parent study	From primary endpoint assessment in the parent study up to Month 33
Percentage of On-NA participants rolling over from study 217023 without loss of FC after NA-cessation in study 206882	From Month 3 up to Month 33

Secondary Outcome Measures

Name	Time	Method
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)	Up to Month 57
Percentage of On-NA and NA-cessated participants with PSPO in the parent study who have virologic relapse or use of any rescue medication after NA cessation (in either parent study or study 206682)	Up to Month 57
Percentage of On-NA and NA-cessated participants with PSPO in the parent study who have clinical relapse or use of any rescue medication after NA cessation (in either parent study or study 206682)	Up to Month 57
Percentage of On-NA and NA-cessated participants with PSPO in the parent study who receive NA retreatment after NA cessation (in either parent study or study 206682)	Up to Month 57
Percentage of On-NA participants with PSPO in the parent study, who continue NA treatment in study 206882, and have no loss of treatment response	From primary endpoint assessment in the parent study up to Month 33
Percentage of Not-on-NA participants with a partial response in the parent study and a delayed FC in study 206882 in absence of rescue medication after end of treatment in the parent study	Up to Month 57
Time to loss of FC from time of achieving delayed FC in Not-on-NA participants with a partial response in the parent study and a delayed FC in study 206882	From date of achieving delayed FC up to Month 57
Percentage of On-NA participants with a partial response in the parent study, who discontinue NA treatment in study 206882, and have a delayed FC in 206882 in absence of rescue medication after end of treatment in the parent study	Up to Month 57
Percentage of On-NA participants with a partial response in the parent study, who discontinue NA treatment in study 206882, and have HBsAg loss in the absence of any rescue medication after NA cessation in 206882	From Month 3 to Month 57
Percentage of On-NA participants with a partial response in the parent study, who discontinue NA treatment in study 206882, and have virologic relapse or use of any rescue medication after NA cessation in 206882	From Month 3 up to Month 57
Percentage of On-NA participants with a partial response in the parent study, who discontinue NA treatment in study 206882, and have clinical relapse or use of any rescue medication after NA cessation in 206882	From Month 3 up to Month 57
Percentage of participants with anti-HBs (antibody to HBsAg)	Up to 57 months
Percentage of participants with anti-HBe (antibody to hepatitis B e-antigen [HBeAg])	Up to 57 months
Absolute values for HBsAg, hepatitis B virus (HBV) deoxyribonucleic acid (DNA), HBeAg (logarithm to the base 10 [log10] international units per milliliter [IU/mL])	Up to 57 months
Change from Baseline for HBsAg, HBV DNA, HBeAg (log10 IU/mL)	Baseline (End of Study visit in the parent study) and up to 57 months
Absolute values for hepatitis B core-related antigen (HBcrAg) (kiloUnits per milliliter [kU/mL])	Up to 57 months
Change from Baseline for HBcrAg (kU/mL)	Baseline (End of Study visit in the parent study) and up to 57 months
Absolute values for HBV ribonucleic acid (RNA) (log10 IU/ml)	Up to 57 months
Change from Baseline for HBV RNA (log10 IU/ml)	Baseline (End of Study visit in the parent study) and up to 57 months
Percentage of participants with mutations	Up to 57 months
Time to loss of FC in On-NA participants who achieve a partial response in the parent study, discontinue NA treatment in study 206882 and achieve delayed FC in 206882	From date of achieving delayed FC up to Month 57
Percentage of On-NA participants with a partial response in the parent study, who do not discontinue NA treatment in study 206882, and have a delayed treatment response in 206882 in absence of rescue medication after end of treatment in the parent study	Up to Month 33
Time to loss of treatment response in On-NA participants who achieve a partial response in the parent study, do not discontinue NA treatment in study 206882 and have a delayed treatment response in 206882	From date of achieving delayed treatment response up to Month 33
Percentage of On-NA participants with a partial response in the parent study, who discontinue NA treatment in study 206882 and have use of any rescue medication after NA cessation in 206882	From Month 3 up to Month 57

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 Plymouth, United Kingdom