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To evaluate the efficacy and safety of combined/uncombined nucleoside (acid) analogues of TQA3810 tablets.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: TQA3810 tablets+NUC | Experimental | Part A: TQA3810 tablets+NUC:A total of 4 dose groups were set up, which were respectively TQA3810 tablets 0.1mg once a day, 0.2mg once every two days, 0.3mg twice a week and 0.2mg once a day combined with oral nucleoside (acid) drugs (NUC) group for 24 weeks. |
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| Part A: Placebo+NUC | Placebo Comparator | Part A: Placebo+NUC: Placebo combined with oral nucleoside (acid) drugs (NUC) group was treated for 24 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQA3810 tablets+NUC | Drug | TQA3810 is a novel, effective and highly selective small-molecule oral Toll-like receptors-8 agonist. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Treated patients must meet the following conditions:
Newly treated patients need to meet the following conditions:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanyan Yu, Doctor | Contact | 13901194223 | yyy@bjmu.edu.cn | |
| Jun Li, Doctor | Contact | 13905175333 | dr-lijun@vip.sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gansu Wuwei Tumour Hospital | Not yet recruiting | Wuwei | Gansu | 733099 | China |
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| Placebo+NUC | Drug | NUC: Entecavir Dispersible Tablets, Inhibit viral replication; Tenofovir Disoproxil Fumarate Tablets, Nucleotide reverse transcriptase inhibitors; Tenofovir Alafenamide Fumarate Tablets, Inhibit HBV replication. |
|
| 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 |
| Zunyi Medical University Affiliated Hospital | Not yet recruiting | Zunyi | Guizhou | 563000 | China |
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| Nanjing Drum Tower Hospital | Not yet recruiting | Nanjing | Jiangsu | 210031 | China |
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| The Fifth People's Hospital of Suzhou | Not yet recruiting | Suzhou | Jiangsu | 215131 | China |
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| Shenyang Sixth People's Hospital | Not yet recruiting | Shenyang | Liaoning | 110000 | China |
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| The First Affiliated Hospital of Xi 'an Jiaotong University | Recruiting | Xi'an | Shaanxi | 710061 | China |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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