This is a multicenter, randomized, double-blind, placebo-controlled Phase III study with an open-label extension. The purpose is to evaluate efficacy and safety in adult patients with chronic hepatitis B virus infection who have received at least 12 months of NAs therapy, to demonstrate that TQA3605 Tablets combined with oral nucleos(t)ide analogues can improve efficacy with satisfactory safety profile compared with oral nucleos(t)ide analogues alone in this population. Approximately 930 adult patients with chronic hepatitis B virus infection who have received at least 12 months of NAs therapy are planned to be enrolled in this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
930
Placebo contains no active substance.
TQA3605 tablets are core protein allosteric modulators
Entecavir dispersible tablets are a type of nucleoside analog antiviral drug.
Tenofovir Disoproxil Fumarate (TDF) is a nucleoside reverse transcriptase inhibitor.
Tenofovir Alafenamide Fumarate (TAF) is a nucleoside reverse transcriptase inhibitor.
Tenofovir Amibufenamide (TMF) is a phosphoramidate prodrug of tenofovir and belongs to nucleos(t)ide reverse transcriptase inhibitors.
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
The First Affiliated Hospital of Ustc(Anhui Provincial Hospital)
Hefei, Anhui, China
The First Affiliated Hospital of Wannan Medical College / Yijishan Hospital of Wannan Medical College
Wuhu, Anhui, China
Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
HBV DNA
Difference in the percentage of trial participants achieving HBV DNA less than 10 IU/mL after 48 weeks of treatment between the treatment group and the control group
Time frame: 48 weeks
HBV DNA
Percentage of trial participants with HBV DNA less than 10 IU/mL at each visit (excluding Week 48)
Time frame: Baseline to week 104
HBV DNA
Percentage of trial participants with HBV DNA less than 20 IU/mL at each visit
Time frame: Baseline to week 104
HBsAg
Percentage of trial participants with HBsAg less than 0.05 IU/mL;
Time frame: Baseline to week 104
HBeAg
Percentage of trial participants achieving HBeAg seroclearance and/or seroconversion
Time frame: Baseline to week 104
Alanine aminotransferase(ALT)
ALT normalization rate over time (ALT ≤ ULN) in trial participants with ALT \> ULN at baseline without administration of liver-protective and transaminase-lowering agents
Time frame: Baseline to week 104
Virology breakthrough
Percentage of trial participants experiencing virologic breakthrough at each visit
Time frame: Baseline to week 104
HBV markers
Actual values of HBsAg, HBeAg, HBV DNA, HBV RNA, and HBcrAg at each visit time point and their changes over time relative to baseline
Time frame: Baseline to week 104
Adverse events (AE)
The incidence and severity of adverse events and serious adverse events
Time frame: From screening to Week 104
Steady state minimum concentration (Cmin,ss)
Cmin,ss of TQA3605 and its metabolite
Time frame: 48 weeks
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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
Chongqing University Three Gorges Hospita
Chongqing, Chongqing Municipality, China
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China
...and 66 more locations