[Translation] Evaluation of Bepirovirsen for the treatment of nucleos(t)ide analogue-treated chronic hepatitis B
A phase III, multicenter, randomized, double-blind study of efficacy and safety in subjects infected with inflammatory virus (BWell 1)
本研究旨在确认Bepirovirsen 300 mg每周一次持续给药24周(含负荷剂量)相较于安慰剂组的有效性、安全性、PK特征以及HBsAg抑制的持久性。
本研究的数据旨在确认Bepirovirsen用于慢性HBV感染受试者的有效性,并确立其安全性特征,为评估获益/风险关系、支持其上市批准提供充分的依据。
[Translation] This study aims to confirm the efficacy, safety, PK characteristics and durability of HBsAg suppression of Bepirovirsen 300 mg once weekly for 24 weeks (including loading dose) compared with the placebo group.
The data of this study aims to confirm the effectiveness of Bepirovirsen in subjects with chronic HBV infection and establish its safety characteristics, so as to provide sufficient basis for evaluating the benefit/risk relationship and supporting its marketing approval.