This is a multicenter, randomized, double-blind, placebo-controlled phase II study, in which all participants are required to use TQA3605 tablets/placebo in combination with entecavir. The purpose is to evaluate the efficacy and safety of TQA3605 tablets combined with entecavir in treatment-naive chronic HBV-infected subjects. A total of 215 subjects are required.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Placebo contains no active substance.
TQA3605 tablets is core protein allosteric modulators
Entecavir dispersible tablets is an inhibitor of hepatitis B virus replication.
hepatitis B virus (HBV) DNA <10 IU/mL
Percentage of subjects with HBV DNA below the lower limit of quantification (\<10 IU/mL) after 48 weeks of treatment.
Time frame: 48 weeks
Percentage of subjects with HBV DNA<10 IU/mL
Percentage of subjects with HBV DNA\<10 IU/mL at week 12, 24, 36, 60, and 72
Time frame: 12 weeks, 24 weeks, 36 weeks, 60 weeks, 72 weeks
Percentage of HBV DNA<20 IU/mL
Percentage of subjects with HBV DNA\<20 IU/mL at weeks 12, 24, 36, 48, 60, and 72 of treatment.
Time frame: 12 weeks, 24 weeks, 36 weeks, 48weeks, 60 weeks, 72 weeks
Percentage of subjects with HBeAg serologic clearance and/or serologic conversion
Percentage of subjects with HBeAg serologic clearance and/or serologic conversion
Time frame: 24weeks, 48 weeks, 72 weeks
Alanine aminotransferase(ALT)≤The upper limit of the normal reference value (ULN)
The rate of ALT normalization at weeks 24, 48, and 72 of treatment
Time frame: 24weeks, 48 weeks, 72 weeks
Virology breakthrough percentage
Percentage of subjects who experienced virological breakthroughs at weeks 24, 48, and 72 of treatment
Time frame: 24weeks, 48 weeks, 72 weeks
Actual values of HBV markers and changes over time relative to baseline
Actual values of HBsAg, HBeAg, HBV DNA, HBV RNA, and Hepatitis B core-related antigen (HBcrAg) at each visit time point and their changes over time relative to baseline.
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Beijing Ditan Hospital Capital Medical University
Beijing, Beijing Municipality, China
Beijing Youan Hospital,Capital Medical University
Beijing, Beijing Municipality, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
The Southwest Hospital of AMU
Chongqing, Chongqing Municipality, China
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China
NanFang Hospital
Guangzhou, Guangdong, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
The First Affiliated Hospital of GUANGXI Medical University
Nanning, Guangxi, China
Hebei Medical University Third Hospital
Shijiazhuang, Hebei, China
Zhengzhou No.6 peoples Hospital
Zhengzhou, Henan, China
...and 19 more locations
Time frame: 12 weeks, 24 weeks, 36 weeks, 48 weeks, 72 weeks
Adverse events (AE)
The incidence and severity of adverse events.
Time frame: 72 weeks
Steady state minimum concentration (Cmin,ss)
Cmin,ss of TQA3605 and its metabolite
Time frame: 48 weeks