Long-term follow-up study to evaluate durability of sustained virologic response in previous GSK3228836 study participants.

A Prospective, Multi-Centre Study (B-Sure) to Evaluate Long-Term Durability of Sustained Virologic Response in Chronic Hepatitis B Participants With and Without Nucleos(t)ide Therapy Who Have Received and Responded to GSK3228836 in a Previous Treatment Study - B-Sure

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000554-26-IT

Enrollment

450

Registered

2021-10-15

Start date

2021-12-15

Completion date

Unknown

Last updated

2022-03-02

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

Conditions

Chronic Hepatitis B MedDRA version: 20.1 Level: PT Classification code 10008910 Term: Chronic hepatitis B System Organ Class: 10021881 - Infections and infestations

Interventions

Product Name: GSK3228836 Product Code: [GSK3228836B (Free acid)

GSK3228836A (Sodium salt Pharmaceutical Form: Injection INN or Proposed INN: Bepirovirsen CAS Number: 1403787-62-1 Current Sponsor code: GSK3228836 Concentration unit: mg/ml milligram(s)/millilitre Co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Participants who have previously received at least one dose of GSK3228836 AND a. Achieved SVR (defined as HBsAg =65 years) yes F.1.3.1 Number of subjects for this age range 112

Exclusion criteria

Exclusion criteria: GSK interventional clinical study exploring HBV treatment since completing their treatment with GSK3228836. 2. Any condition which, in the opinion of the investigator or Medical Monitor, contraindicates their participant in this study.

Design outcomes

Primary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Defined in the primary endpoints;Main Objective: To describe long-term durability of sustained virologic response (SVR) as measured by time to loss of SVR in the following two groups: • Treatment naïve participants who achieved a complete response. Participants who achieved a complete response in the parent study and either didn't meet the eligibility criteria or met the eligibility criteria and decided not to enrol will be included in the analysis. • NA controlled participants who achieved a complete response and discontinued NA treatment per protocol (Section 6.8.1 of the protocol);Secondary Objective: • Describe changes in disease after NA cessation as measured by time to HBsAg reversion, time to virologic relapse, time to clinical relapse and time to NA retreatment in NA controlled participants who achieved a complete response and discontinued NA treatment. • To describe long-term durability of sustained virologic response (SVR) as measured by time to loss of SVR in NA controlled participants who achieved a complete response and are continuing NA treatment. • Describe achieving delayed SVR in treatment naive participants who achieved a partial response, and describe time to loss of SVR in participants achieving delayed SVR. • Describe achieving delayed SVR in NA controlled participants who achieved a partial response, and describe time to loss of SVR in participants achieving delayed SVR. Please, refer to the study protocol for the complete list of secondary objectives.;Primary end point(s): • Time from achieving SVR in the previous GSK3228836 treatment study to the loss of SVR (first occurrence of either HBsAg or HBV DNA reversion, or first use of any rescue medication). • Time from NA cessation to the loss of SVR (first occurrence of either HBsAg or HBV DNA reversion or first use of any rescue medication).	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Defined in the primary endpoints;Main Objective: To describe long-term durability of sustained virologic response (SVR) as measured by time to loss of SVR in the following two groups: • Treatment naïve participants who achieved a complete response. Participants who achieved a complete response in the parent study and either didn't meet the eligibility criteria or met the eligibility criteria and decided not to enrol will be included in the analysis. • NA controlled participants who achieved a complete response and discontinued NA treatment per protocol (Section 6.8.1 of the protocol);Secondary Objective: • Describe changes in disease after NA cessation as measured by time to HBsAg reversion, time to virologic relapse, time to clinical relapse and time to NA retreatment in NA controlled participants who achieved a complete response and discontinued NA treatment. • To describe long-term durability of sustained virologic response (SVR) as measured by time to loss of SVR in NA controlled participants who achieved a complete response and are continuing NA treatment. • Describe achieving delayed SVR in treatment naive participants who achieved a partial response, and describe time to loss of SVR in participants achieving delayed SVR. • Describe achieving delayed SVR in NA controlled participants who achieved a partial response, and describe time to loss of SVR in participants achieving delayed SVR. Please, refer to the study protocol for the complete list of secondary objectives.;Primary end point(s): • Time from achieving SVR in the previous GSK3228836 treatment study to the loss of SVR (first occurrence of either HBsAg or HBV DNA reversion, or first use of any rescue medication). • Time from NA cessation to the loss of SVR (first occurrence of either HBsAg or HBV DNA reversion or first use of any rescue medication).

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Secondary

Measure	Time frame
Secondary end point(s): • 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 • Time from NA cessation to the first occurrence of clinical relapse or first use of any rescue medication • Time from NA cessation to NA retreatment • Time from achieving SVR in the previous GSK3228836 treatment study to the loss of SVR (first occurrence of either HBsAg or HBV DNA reversion, or first use of any rescue medication). • Time from end of treatment in the previous GSK3228836 treatment study to delayed SVR in the absence of rescue medication • In the subset of participants who go on to achieve a delayed SVR: Time to the loss of SVR from time of achieving delayed SVR • In NA controlled participants who are continuing NA treatment: - Time from end of treatment in the previous GSK3228836 treatment study to delayed SVR in the absence of any rescue medication - In the subset of participants who go on to achieve a delayed SVR: Time to the loss of SVR from time of achieving delayed SVR • In NA controlled participants who have discontinued NA treatment: - Time from NA cessation to delayed SVR, in the absence of NA retreatment. - In the subset of participants who go on to achieve a delayed SVR after NA cessation: Time to the loss of SVR from time of achieving SVR. • Time from NA cessation to HBsAg loss in the absence of any rescue medication • Time from NA cessation to the first occurrence of virologic relapse or first use of any rescue medication • Time from NA cessation to the first occurrence of clinical relapse or first use of any rescue medication • Time from NA cessation to the first occurrence of NA retreatment • Occurrence of anti-HBs (antibody to HBsAg) • Occurrence of anti-HBe (antibody to HBeAg) • Actual values and changes from Baseline (EoS visit in the parent study) at each study visit in HBsAg, HBV DNA, HBeAg, HBcrAg	—

Measure

Time frame

Secondary end point(s): • 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 • Time from NA cessation to the first occurrence of clinical relapse or first use of any rescue medication • Time from NA cessation to NA retreatment • Time from achieving SVR in the previous GSK3228836 treatment study to the loss of SVR (first occurrence of either HBsAg or HBV DNA reversion, or first use of any rescue medication). • Time from end of treatment in the previous GSK3228836 treatment study to delayed SVR in the absence of rescue medication • In the subset of participants who go on to achieve a delayed SVR: Time to the loss of SVR from time of achieving delayed SVR • In NA controlled participants who are continuing NA treatment: - Time from end of treatment in the previous GSK3228836 treatment study to delayed SVR in the absence of any rescue medication - In the subset of participants who go on to achieve a delayed SVR: Time to the loss of SVR from time of achieving delayed SVR • In NA controlled participants who have discontinued NA treatment: - Time from NA cessation to delayed SVR, in the absence of NA retreatment. - In the subset of participants who go on to achieve a delayed SVR after NA cessation: Time to the loss of SVR from time of achieving SVR. • Time from NA cessation to HBsAg loss in the absence of any rescue medication • Time from NA cessation to the first occurrence of virologic relapse or first use of any rescue medication • Time from NA cessation to the first occurrence of clinical relapse or first use of any rescue medication • Time from NA cessation to the first occurrence of NA retreatment • Occurrence of anti-HBs (antibody to HBsAg) • Occurrence of anti-HBe (antibody to HBeAg) • Actual values and changes from Baseline (EoS visit in the parent study) at each study visit in HBsAg, HBV DNA, HBeAg, HBcrAg

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Countries

Argentina, Bulgaria, Canada, China, France, Germany, Hong Kong, Italy, Japan, Korea, Republic of, Malaysia, Netherlands, Philippines, Poland, Romania, Russian Federation, Singapore, South Africa, Spain, Taiwan, Thailand, United Kingdom, United States

Contacts

Public ContactClinical Trials Help Desk

GlaxoSmithKline Research & Development Ltd

GSKClinicalSupportHD@gsk.com+442089909733

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026