A Clinical Trial to Evaluate the Efficacy and Safety of TQA3810 Tablets in Combination/Non Combination With Nucleoside (Acid) Analogues in Patients With Primary/Treated Chronic Hepatitis B
NCT Number: NCT06566248
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Chronic Hepatitis B
Interventions: DRUG: TQA3810 tablets+NUC|DRUG: Placebo+NUC
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
Start Date: 2024-03-20
Completion Date: 2025-03
Locations: Gansu Wuwei Tumour Hospital, Wuwei, Gansu, 733099, China|Zunyi Medical University Affiliated Hospital, Zunyi, Guizhou, 563000, China|Nanjing Drum Tower Hospital, Nanjing, Jiangsu, 210031, China|The Fifth People's Hospital of Suzhou, Suzhou, Jiangsu, 215131, China|Shenyang Sixth People's Hospital, Shenyang, Liaoning, 110000, China|The First Affiliated Hospital of Xi 'an Jiaotong University, Xi'an, Shaanxi, 710061, China

Summary:
To evaluate the efficacy and safety of combined/uncombined nucleoside (acid) analogues of TQA3810 tablets.

Primary Outcome Measures: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) during the study period, The study required collection of any adverse medical events, whether causally associated with the investigational drug or not, from the time the subject signed the informed consent to 28 days after the end of study medication or the initiation of other anti-HBV therapy (whichever came first)., Up to 52 months
Secondary Outcome Measures: Changes in serum HBsAg, Changes in serum HBsAg from baseline at 24 weeks, 24 weeks|HBV DNA level changes and drug resistance monitoring, Changes in HBV DNA levels from baseline and drug resistance monitoring., 24 weeks|HBeAg level change, Changes in HBeAg levels from baseline., 24 weeks|HBsAg clearance and/or serological conversion, Percentage of subjects with HBsAg clearance and/or serological conversion., 24 weeks|HBeAg clearance and/or serological conversion, Percentage of subjects with HBeAg clearance and/or serological conversion, 24 weeks|HBsAg level decreased by ≥0.5log10 IU/ml, Proportion of subjects with HBsAg levels decreased at least 0.5log10 IU/ml, 24 weeks|Changes of HBV RNA and hepatitis B core-related antigen (HBcrAg) levels during treatment, Changes of HBV RNA and HBcrAg levels from baseline during treatment, 24 weeks|Peak time (Tmax), Time to peak blood concentration after a single dose., In 60 minutes pre-dose on day 1, 0.5, 1, 2, 4, 12 hours after dose; Day 15 within 60 minutes pre-dose; Day 29 within 60 minutes pre-dose; Day 57 within 60 minutes pre-dose; Day 85 within 60 minutes pre-dose, 0.5, 1, 2, 4, 12 hours after dose|Peak Concentration, The highest plasma drug concentration that can be achieved after medication., In 60 minutes pre-dose on day 1, 0.5, 1, 2, 4, 12 hours after dose; Day 15 within 60 minutes pre-dose; Day 29 within 60 minutes pre-dose; Day 57 within 60 minutes pre-dose; Day 85 within 60 minutes pre-dose, 0.5, 1, 2, 4, 12 hours after dose|Area under blood concentration-time curve (AUC), The amount of drug absorbed into the human circulation after a single dose can be estimated using the area under the blood concentration-time curve., In 60 minutes pre-dose on day 1, 0.5, 1, 2, 4, 12 hours after dose; Day 15 within 60 minutes pre-dose; Day 29 within 60 minutes pre-dose; Day 57 within 60 minutes pre-dose; Day 85 within 60 minutes pre-dose, 0.5, 1, 2, 4, 12 hours after dose|Apparent volume of distribution (Vd/F), When a drug reaches homeostasis in the body, the ratio of the amount of drug in the body to the blood concentration is called the apparent volume of distribution., In 60 minutes pre-dose on day 1, 0.5, 1, 2, 4, 12 hours after dose; Day 15 within 60 minutes pre-dose; Day 29 within 60 minutes pre-dose; Day 57 within 60 minutes pre-dose; Day 85 within 60 minutes pre-dose, 0.5, 1, 2, 4, 12 hours after dose|Plasma clearance, How many milliliters of plasma can the kidneys completely clear in unit time (per minute)., In 60 minutes pre-dose on day 1, 0.5, 1, 2, 4, 12 hours after dose; Day 15 within 60 minutes pre-dose; Day 29 within 60 minutes pre-dose; Day 57 within 60 minutes pre-dose; Day 85 within 60 minutes pre-dose, 0.5, 1, 2, 4, 12 hours after dose|Elimination half-life time, The time it takes for the plasma concentration to drop by half, In 60 minutes pre-dose on day 1, 0.5, 1, 2, 4, 12 hours after dose; Day 15 within 60 minutes pre-dose; Day 29 within 60 minutes pre-dose; Day 57 within 60 minutes pre-dose; Day 85 within 60 minutes pre-dose, 0.5, 1, 2, 4, 12 hours after dose|Peaking Time, The time required to reach peak steady-state concentration after administration., In 60 minutes pre-dose on day 1, 0.5, 1, 2, 4, 12 hours after dose; Day 15 within 60 minutes pre-dose; Day 29 within 60 minutes pre-dose; Day 57 within 60 minutes pre-dose; Day 85 within 60 minutes pre-dose, 0.5, 1, 2, 4, 12 hours after dose|Steady state maximum concentration, The highest blood concentration that occurs After stabilization, In 60 minutes pre-dose on day 1, 0.5, 1, 2, 4, 12 hours after dose; Day 15 within 60 minutes pre-dose; Day 29 within 60 minutes pre-dose; Day 57 within 60 minutes pre-dose; Day 85 within 60 minutes pre-dose, 0.5, 1, 2, 4, 12 hours after dose|Steady state minimal concentration, The lowest blood concentration that occurs after stabilization., In 60 minutes pre-dose on day 1, 0.5, 1, 2, 4, 12 hours after dose; Day 15 within 60 minutes pre-dose; Day 29 within 60 minutes pre-dose; Day 57 within 60 minutes pre-dose; Day 85 within 60 minutes pre-dose, 0.5, 1, 2, 4, 12 hours after dose|Area under steady-state blood concentration-time curve, The area under the curve obtained with blood drug concentration as the vertical axis and time as the horizontal axis after administration., In 60 minutes pre-dose on day 1, 0.5, 1, 2, 4, 12 hours after dose; Day 15 within 60 minutes pre-dose; Day 29 within 60 minutes pre-dose; Day 57 within 60 minutes pre-dose; Day 85 within 60 minutes pre-dose, 0.5, 1, 2, 4, 12 hours after dose|Evaluate whether TQA3810 will affect the heart rate-corrected QT interval (QTc) of newly treated/treated chronic hepatitis B patients, Evaluate whether TQA3810 will affect the QTc interval of newly treated/treated chronic hepatitis B patients, 24 weeks|Pharmacodynamic characteristics (IFN-γ, IL-1RA, CCL2, CCL4, CCL8, CCL11, CCL20, CXCL8, IL-12p70, IL-12p40, TNF-α, CRP), Characteristics of IFN-γ, interleukin-1 receptor antagonist (IL-1RA), chemokine (C-C motif) ligand 2 (CCL2), Chemokine (C-C motif) ligands 4 (CCL4) , Chemokine (C-C motif) ligands 8 (CCL8), Chemokine (C-C motif) ligands 11 (CCL11), Chemokine (C-C motif) ligands 20 (CCL20), C-X-C motif chemokine ligand 8 (CXCL8), IL-12p70, IL-12p40, Tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), In 60 minutes pre-dose on day 1, 0.5, 1, 2, 4, 12 hours after dose; Day 15 within 60 minutes pre-dose; Day 29 within 60 minutes pre-dose; Day 57 within 60 minutes pre-dose; Day 85 within 60 minutes pre-dose, 0.5, 1, 2, 4, 12 hours after dose