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NCT04954859

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

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
GlaxoSmithKline·Phase 2·ClinicalTrials.gov·drugNot yet recruiting
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Study focus
Disease/Condition
Hepatitis B
Drug/Device/Intervention
GSK3228836
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
GlaxoSmithKline
Timeline & enrollment
Phase
Phase 2
Start date
Nov 30, 2021
End date
Jan 25, 2029
Enrollment
450 participants
Primary outcome

Time from achieving SVR in previous GSK3228836 treatment study to loss of SVR (1st occurrence of either hepatitis B surface antigen or hepatitis B virus deoxyribonucleic acid [DNA] reversion, or 1st use of any rescue medication)-NA naïve participants,Time from NA cessation to the loss of SVR-NA controlled participants

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.

ICD-10 classifications
Acute hepatitis BAcute hepatitis B without delta-agent and without hepatic comaAcute delta-(super)infection in chronic hepatitis BChronic viral hepatitis B without delta-agentChronic viral hepatitis B without delta-agent : other and unspecified phase
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT04954859
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT04954859 through Pure Global AI's free database. This Phase 2 trial is sponsored by GlaxoSmithKline and is currently Not yet recruiting. The study focuses on Hepatitis B. Target enrollment is 450 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.