[Translation] A multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial to evaluate the efficacy and safety of TVAX-008 injection in the treatment of chronic hepatitis B
主要目的:评价 TVAX-008 注射液的有效性。
次要目的:评价 TVAX-008 注射液的安全性。
探索性目的:探索实现功能性治愈[定义为实现血清 HBsAg 转阴(HBsAg<0.05 IU/mL)和血清乙型肝炎病毒脱氧核糖核酸(HBV DNA)<定量下限(LLOQ)]的受试者肝内 HBV 相关标志物。
[Translation] Primary objective: To evaluate the efficacy of TVAX-008 injection.
Secondary objective: To evaluate the safety of TVAX-008 injection.
Exploratory objective: To explore the hepatic HBV-related markers in subjects who have achieved functional cure [defined as serum HBsAg negative conversion (HBsAg < 0.05 IU/mL) and serum hepatitis B virus deoxyribonucleic acid (HBV DNA) < lower limit of quantification (LLOQ)].