[Translation] A randomized, phase IIa, multicenter, open-label study evaluating an ABI-H0731-containing regimen in patients with chronic hepatitis B
主要目的 评估731联用ETV±Peg-IFNα治疗CHB受试者时的安全性和耐受性 次要目的 评估731联用ETV±Peg-IFNα降低CHB受试者HBV pgRNA水平的作用 评估731联用ETV±Peg-IFNα降低CHB受试者HBV DNA水平的作用 评估731联用ETV±Peg-IFNα降低CHB受试者HBV抗原(即HBeAg、HBcrAg和HBsAg)的作用 评估731联用ETV±Peg-IFNα对使丙氨酸氨基转移酶(ALT)恢复正常的作用 在CHB受试者中评估731的PK以及在未来评估Peg-IFNα和ETV的PK 评估731联用ETV±Peg-IFNα时耐药性的形成情况
[Translation] Primary objective To evaluate the safety and tolerability of 731 combined with ETV±Peg-IFNα in CHB subjects Secondary objective To evaluate the effect of 731 combined with ETV±Peg-IFNα to reduce the level of HBV pgRNA in CHB subjects To evaluate the combined use of 731 Evaluation of the effect of ETV±Peg-IFNα on reducing HBV DNA levels in CHB subjects Effects on normalization of alanine aminotransferase (ALT) Assess the PK of 731 in CHB subjects and in the future PK of Peg-IFNα and ETV Assess resistance to 731 in combination with ETV ± Peg-IFNα Formation