Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Condition(s) studied
Investigational drug(s) / intervention(s)
Bepirovirsen: No study drug will be administered in this study. Eligible participants who received prior treatment with bepirovirsen in the parent studies will be included.
Placebo: No study drug will be administered in this study. Eligible participants who received prior treatment with placebo in the parent studies (209668, 202009, and 219288) will be included to maintain the blind in the still ongoing parent studies.
Study summary
This is a global multi-center, long-term follow-up study to assess durability of efficacy, as measured by maintenance of treatment response from the parent study, in participants who participated in a previous bepirovirsen study and achieved a complete or partial response. Eligible participants will be enrolled in this study after completing the end of study (EoS) visit in the respective parent bepirovirsen studies (studies B-Clear \[209668: NCT04449029\], B-Together \[209348: NCT04676724\], B-Fine \[212602: NCT04544956\], B-Well 1 \[202009: NCT05630807\], B-Well 2 \[219288: NCT05630820\], and TH HBV ASO-001 \[217023: NCT05276297\]). Participants will be categorized as Not-on-NA, NA-cessated, or On-NA based on their nucleos(t)ide analogue (NA) status in the parent study. No further treatment with bepirovirsen will be administered in this study.
Eligibility
Primary outcome measure(s)
- 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 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
- 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
Trial sites (163)
| Facility | City | Region | Status |
|---|---|---|---|
| GSK Investigational Site | Sacramento | California | |
| GSK Investigational Site | San Jose | California | |
| GSK Investigational Site | Colorado Springs | Colorado | |
| GSK Investigational Site | Boston | Massachusetts | |
| GSK Investigational Site | Detroit | Michigan | |
| GSK Investigational Site | La Plata | Buenos Aires | |
| GSK Investigational Site | Buenos Aires | Argentina | |
| GSK Investigational Site | Buenos Aires | Argentina | |
| GSK Investigational Site | Rosario | Argentina | |
| GSK Investigational Site | Santa Fe | Argentina | |
| GSK Investigational Site | Herston | Queensland | |
| GSK Investigational Site | Fitzroy | Victoria | |
| GSK Investigational Site | Aracaju | Sergipe | |
| GSK Investigational Site | Campinas | Brazil | |
| GSK Investigational Site | Curitiba | Brazil | |
| GSK Investigational Site | Manaus | Brazil | |
| GSK Investigational Site | São Paulo | Brazil | |
| GSK Investigational Site | Vila Mariana | Brazil | |
| GSK Investigational Site | Plovdiv | Bulgaria | |
| GSK Investigational Site | Sliven | Bulgaria | |
| GSK Investigational Site | Sofia | Bulgaria | |
| GSK Investigational Site | Sofia | Bulgaria | |
| GSK Investigational Site | Sofia | Bulgaria | |
| GSK Investigational Site | Varna | Bulgaria | |
| GSK Investigational Site | Calgary | Alberta | |
| GSK Investigational Site | Victoria | British Columbia | |
| GSK Investigational Site | Toronto | Ontario | |
| GSK Investigational Site | Montreal | Quebec | |
| GSK Investigational Site | Montreal | Quebec | |
| GSK Investigational Site | Québec | Quebec | |
| GSK Investigational Site | Beijing | China | |
| GSK Investigational Site | Beijing | China | |
| GSK Investigational Site | Beijing | China | |
| GSK Investigational Site | Chengdu | China | |
| GSK Investigational Site | Chengdu | China | |
| GSK Investigational Site | Chongqing | China | |
| GSK Investigational Site | Fuzhou | China | |
| GSK Investigational Site | Guangzhou | China | |
| GSK Investigational Site | Guangzhou | China | |
| GSK Investigational Site | Guangzhou | China |
+ 123 more sites — see the full list on the official registry below.
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04954859 on ClinicalTrials.gov ↗ ← All trials in South Korea