[Translation] A multicenter, randomized, partially placebo-controlled, double-blind, phase IIb study to investigate the safety and efficacy of daplusiran/tomligisiran followed by bepirovirsen in subjects with chronic hepatitis B receiving background nucleos(t)ide analog therapy (B-United)
主要目的:
有效性:评估两种不同剂量的DAP/TOM持续24周序贯Bepirovirsen 300 mg每周一次(含负荷剂量)持续24周治疗,在慢性HBV感染受试者(接受NA治疗;基线HBsAg不设限的所有受试者)中实现功能性治愈的治疗效果。
次要目的:
有效性:评估两种不同剂量的DAP/TOM持续24周序贯Bepirovirsen 300 mg每周一次(含负荷剂量)持续24周治疗,在慢性HBV感染受试者(接受NA治疗且基线HBsAg>3000 IU/mL)中实现功能性治愈的治疗效果。
有效性:评估两种不同剂量的DAP/TOM或安慰剂持续24周序贯Bepirovirsen 300 mg每周一次(含负荷剂量)持续24周治疗,在慢性HBV感染受试者(接受NA治疗且基线HBsAg≤3000 IU/mL)中实现功能性治愈的治疗效果。
[Translation] Primary objective:
Efficacy: To evaluate the therapeutic effect of two different doses of DAP/TOM for 24 weeks followed by Bepirovirsen 300 mg once weekly (including loading dose) for 24 weeks to achieve functional cure in chronic HBV infected subjects (receiving NA treatment; all subjects with no restriction on baseline HBsAg).
Secondary objective:
Efficacy: To evaluate the therapeutic effect of two different doses of DAP/TOM for 24 weeks followed by Bepirovirsen 300 mg once weekly (including loading dose) for 24 weeks to achieve functional cure in chronic HBV infected subjects (receiving NA treatment and baseline HBsAg>3000 IU/mL).
Efficacy: To evaluate the therapeutic effect of two different doses of DAP/TOM or placebo for 24 weeks followed by Bepirovirsen 300 mg once weekly (including loading dose) for 24 weeks to achieve functional cure in chronic HBV infected subjects (receiving NA treatment and baseline HBsAg≤3000 IU/mL).