This study is a phase II multicenter, randomized, double-blind, placebo controlled study designed to evaluate the efficacy and safety in LLV subjects and demonstrate that TQA3605 tablets combined with oral NAs drugs can improve the efficacy and safety of LLV subjects compared with oral NAs drug.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
122
TQA3605 tablets is core protein regulator
Placebo without drug substance
Beijing Ditan Hospital Capital Medical University
Beijing, Beijing Municipality, China
HBV DNA (Hepatitis B virus Deoxyribonucleic Acid)
Percentage of subjects with HBV DNA below the lower limit of quantitative detection (\<10 IU/mL) at 24 weeks of treatment
Time frame: 24 weeks
Incidence and severity of Adverse events (AEs)
The incidence and severity of AEs were determined by changes in physical examination, vital signs, electrocardiogram, and laboratory tests
Time frame: 32 weeks
Incidence and severity of serious adverse events (SAEs)
The incidence and severity of SAEs were determined by changes in physical examination, vital signs, electrocardiogram, and laboratory tests
Time frame: 32 weeks
HBV DNA (<10 IU/mL)
Percentage of subjects with HBV DNA below the lower limit of quantitative detection (\<10 IU/mL)
Time frame: Weeks 12, Weeks 16, Weeks 28, Weeks 32
HBV DNA (<10 IU/mL)
Percentage of subjects with HBV DNA below the lower limit of quantitative detection (\<10 IU/mL)
Time frame: Weeks 12, Weeks 16, Weeks 24, Weeks 28, Weeks 32
Hepatitis B e antigen (HBeAg) Serology
Percentage of subjects with HBeAg serologic clearance and/or serologic conversion (for HBeAg positive at baseline only)
Time frame: Weeks 12, Weeks 24, Weeks 32
Alanine Aminotransferase (ALT) relapse rate
Renormalize ALT over time in subjects with baseline ALT\>upper limit of normal (ULN) in the absence of enzyme-lowering Liver protection medicine
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Beijing Youan Hospital, Capital Medical Universitybeijing Institute of Hepatology
Beijing, Beijing Municipality, China
Meng Chao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China
Zunyi Medical University Affiliated Hospital
Zunyi, Guizhou, China
Zhengzhou No.6 peoples Hospital
Zhengzhou, Henan, China
The Second XIANGYA Hospital Of Central South University
Changsha, Hunan, China
Yueyang Central Hospital
Yueyang, Hunan, China
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China
...and 9 more locations
Time frame: Weeks 12, Weeks 24, Weeks 32
Breakthroughs in virology
Percentage of subjects with a virological breakthrough
Time frame: Weeks 12, Weeks 24, Weeks 32
Actual values and changes of HbsAg (Hepatitis B Surface Antigen)
Actual values and changes of HbsAg over time relative to baseline
Time frame: Weeks 12, Weeks 24, Weeks 32
Actual values and changes of HBeAg
Actual values and changes of HBeAg over time relative to baseline
Time frame: Weeks 12, Weeks 24, Weeks 32
Actual values and changes of HBV DNA
Actual values and changes of HBV DNA over time relative to baseline
Time frame: Weeks 12, Weeks 24, Weeks 32
HBV RNA (Hepatitis B virus Ribonucleic Acid)
Actual values and changes of HBV RNA over time relative to baseline
Time frame: Weeks 12, Weeks 24, Weeks 32
Actual values and changes of Human Hepatitis B virus core antigen - associated antigen (HbcrAg)
Actual values and changes of HbcrAg over time relative to baseline
Time frame: Weeks 12, Weeks 24, Weeks 32
(Cmax, ss) Steady-state maximum concentration
Steady-state maximum concentration of TQA3605
Time frame: Day 1, Day 29, Day 57, Day 85, Day 113, Day 169
(Cmin, ss) Steady state minimum concentration
Steady-state minimum concentration of TQA3605
Time frame: Day 1, Day 29, Day 57, Day 85, Day 113, Day 169