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ベピロビルセンの過去の試験参加者における治療反応の持続性を評価するための長期追跡調査(B-Sure)

基本情報

NCT ID
NCT04954859
ステータス
募集中
試験のフェーズ
第2相
試験タイプ
介入
目標被験者数
450
治験依頼者名
GlaxoSmithKline

概要

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.

対象疾患

Hepatitis B

介入

Bepirovirsen(DRUG)
Placebo(DRUG)

依頼者(Sponsor)