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Long-term Follow-up Study to Evaluate Durability of Sustained Virologic Response (SVR) in Previous GSK3228836 Study Participants (B-Sure) - Trial NCT04954859

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.

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NCT04954859
Phase 2
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT04954859
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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

Study Focus

Hepatitis B

GSK3228836

Interventional

drug

Sponsor & Location

GlaxoSmithKline

Timeline & Enrollment

Phase 2

Nov 30, 2021

Jan 25, 2029

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 naรฏve 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 B
Acute hepatitis B without delta-agent and without hepatic coma
Acute delta-(super)infection in chronic hepatitis B
Chronic viral hepatitis B without delta-agent
Chronic viral hepatitis B without delta-agent : other and unspecified phase

Data Source

ClinicalTrials.gov

NCT04954859

Non-Device Trial