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

• Status: Not yet recruiting
• Trial end date: 2029-01-25
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline

Criteria

Inclusion criteria:

• Participants who have previously received at least one dose of GSK3228836 and

1. Achieved SVR (defined as HBsAg and HBV DNA < lower limit of quantification (LLOQ) from end of previous investigational treatment until the End of study (EoS) visit in the previous treatment study (complete responder) OR

2. Participants who have previously received at least one dose of GSK3228836 and demonstrated a partial response to GSK3228836 in the previous treatment study

• Participants who enter the study on stable NA must be willing to discontinue NA treatment in accordance with the NA discontinuation schedule.

• Capable of giving signed informed consent.

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.