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.