Bepirovirsen
DrugNo study drug will be administered in this study. Eligible participants who received prior treatment with bepirovirsen in the parent studies will be included.
NCT Number: NCT04954859
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 2
GSK Investigational Site, La Plata, Buenos Aires, Argentina
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
For participants rolling over from 209668 (B-Clear), 209348 (B-Together), and 212602 (B-Fine):
For participants rolling over from 202009 (B-Well1) and 219288 (B-Well 2):
For participants rolling over from 217023 (TH HBV ASO-001):
Exclusion criteria
No study drug will be administered in this study. Eligible participants who received prior treatment with bepirovirsen in the parent studies will be included.
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.
Time frame: From primary endpoint assessment in the parent study up to Month 57
NA indicates nucleos(t)ide analogue (NA).
Time frame: From Month 3 up to Month 57
Time frame: From Month 3 up to Month 33
Time frame: From primary endpoint assessment in the parent study up to Month 33
Time frame: Up to Month 57
Time frame: Up to Month 57
Time frame: Up to Month 57
Time frame: Up to Month 57
Time frame: From primary endpoint assessment in the parent study up to Month 33
Time frame: Up to Month 57
Time frame: From date of achieving delayed FC up to Month 57
Time frame: Up to Month 57
Time frame: From date of achieving delayed FC up to Month 57
Time frame: Up to Month 33
Time frame: From date of achieving delayed treatment response up to Month 33
Time frame: From Month 3 to Month 57
Time frame: From Month 3 up to Month 57
Time frame: From Month 3 up to Month 57
Time frame: From Month 3 up to Month 57
Time frame: Up to 57 months
Time frame: Up to 57 months
Time frame: Up to 57 months
Time frame: Baseline (End of Study visit in the parent study) and up to 57 months
Time frame: Up to 57 months
Time frame: Baseline (End of Study visit in the parent study) and up to 57 months
Time frame: Up to 57 months
Time frame: Baseline (End of Study visit in the parent study) and up to 57 months
Time frame: Up to 57 months
GlaxoSmithKline
Industry
A Prospective, Multi-Centre Study (B-Sure) to Evaluate Long-Term Durability of Treatment Response in Chronic Hepatitis B Participants With and Without Nucleos(t)Ide Therapy Who Have Participated in a Previous Bepirovirsen Treatment Study
Acronym: B-Sure
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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