[Translation] A randomized, double-blind, placebo-controlled Phase II clinical trial to evaluate the efficacy and safety of TQA3605 tablets in previously treated subjects with chronic HBV infection and low viremia
主要目的:评价在经治的低病毒血症的慢性HBV感染受试者中,TQA3605片联合口服核苷(酸)类药物对比核苷(酸)类药物单药治疗,是否能够显著提高24周HBV DNA低于定量检测值下限(<20 IU/mL)的受试者百分比。
次要目的:评价TQA3605片联合口服核苷(酸)类药物在经治的低病毒血症的慢性HBV感染受试者中的安全性、耐受性;评价TQA3605片联合口服核苷(酸)类药物在经治的低病毒血症的慢性HBV感染受试者中的有效性;评价TQA3605片联合口服核苷(酸)类药物在经治的低病毒血症的慢性HBV感染受试者中的药代动力学(PK)特征。
[Translation] Main purpose: To evaluate whether TQA3605 tablets combined with oral nucleoside(acid) drugs compared with nucleoside(acid) drug monotherapy can significantly improve the 24 Percentage of subjects with weekly HBV DNA lower than the lower limit of quantitative detection value (<20 IU/mL).
Secondary purpose: To evaluate the safety and tolerability of TQA3605 tablets combined with oral nucleos(t)ide drugs in subjects with chronic HBV infection with low viremia; to evaluate the safety and tolerability of TQA3605 tablets combined with oral nucleos(t)ide drugs. The effectiveness of TQA3605 tablets combined with oral nucleos(t)ide drugs in treated subjects with chronic HBV infection and low viremia. Pharmacokinetic (PK) characteristics.