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This study uses random, double -blindness, placebo control, and phase multi -center test design. All subjects who meet the standards receive TQ-A3334 per tablet/placebo nucleoside (acid) analog. A total of 116 subjects are needed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQ-A3334 tablets 0.2mg quaque die (QD), combined with nucleoside (acid) analogs (NAs) | Active Comparator | TQA3334 tablets 0.2mg once a day 0.2 mg/time, 1 time/night, 48 weeks of administration; 1 time/day for combined medication, 72 weeks of administration; 72 weeks. |
|
| 0.2mg quaque die (QD) placebo, combined with nucleoside (acid) analogs (NAs) | Placebo Comparator | Placebo tablets 0.2mg once a day,0.2 mg/time, 1 time/night, 48 weeks of administration; 1 time/day for combined medication, 72 weeks of administration; 72 weeks. |
|
| TQ-A3334 tablets 0.5mg once the next day(QOD), combined with nucleoside (acid) analogs (NAs) | Active Comparator | TQA333 tablets 0.5mg once the next day once the next day, administration for 48 weeks; combined medication 1/day, 72 weeks of administration. |
|
| Placebo 0.5mg once the next day (QOD) , combined with nucleoside (acid) analogs (NAs) | Placebo Comparator | Placebo 0.5mg once the next day, administration for 48 weeks; combined medication 1/day, 72 weeks of administration; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo contains no active substance. |
|
| Measure | Description | Time Frame |
|---|---|---|
| At 24 weeks, the changes in serum HBSAG relative to the baseline | Evaluate the subject of chronic HBV infection in the early treatment/treatment of chronic HBV infection, TQ-A3334 combined with oral nucleoside (acid) drugs comparative placebo and oral nucleoside (acid) drugs, can it significantly improve the treatment for 24 weeks Serum HBSAG relative to the changes in the baseline | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of adverse events（AEs） | To investigate the incidence of adverse events (AEs) during treatment | Up to 48 weeks |
| Severity of adverse events (AEs) | To study the severity of adverse events (AEs) during treatment |
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Inclusion Criteria:
Those who meet all the selected standards below can enter the group test:
Those who have been treated after treatment need to meet the following conditions:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | 400016 | China | ||
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| TQ-A3334 tablets 0.5mg quaque die (QD), combined with nucleoside (acid) analogs (NAs) |
| Active Comparator |
TQA3334 tablets 0.5mg once a day, 1/night, 48 weeks of administration; 1 time/day for combined medication, 72 weeks of administration; 72 weeks. |
|
| Placebo 0.5mg quaque die (QD) combined with nucleoside (acid) analogs (NAs) | Placebo Comparator | Placebo 0.5mg once a day, 1/night, 48 weeks of administration; 1 time/day for combined medication, 72 weeks of administration; 72 weeks. |
|
| TQA3334 Tablet | Drug | Inhibit viral replication. |
|
| Nucleoside (acid) analogs (NAs) | Drug | Inhibit viral replication. |
|
| Up to 48 weeks |
| Incidence of serious adverse events (SAEs) | To investigate the incidence of serious adverse events (SAEs) during treatment | Up to 48 weeks |
| Severity of serious adverse events（SAEs） | To investigate the severity of serious adverse events (SAEs) during treatment | Up to 28 weeks |
| HBsAg<100 IU/ml and HBV DNA <20 IU/ml subject | The proportion of subjects of HBsAg<100 IU/ml and HBV DNA <20 IU/ml. | Week 24, 48 weeks, 60 weeks, 72 weeks |
| HBSAG self -based lines drop ≥0.5, ≥1 Log10IU/ml | Awarded by HBSAG's self -base line decrease ≥0.5, ≥1 Log10IU/ml. | Week 24, 48 weeks, 60 weeks, 72 weeks |
| The proportion of subjects of HBSAG serological removal and/or serum transformation during the study period | HBSAG serum science clearance and/or serum transition ratio proportion | Week 24, 48 weeks, 60 weeks, 72 weeks |
| The proportion of subjects of HBEAG serological removal and/or serum conversion during the study period | The proportion of subjects of HBEAG serological removal and/or serum transformation during the study. | Week 24, 48 weeks, 60 weeks, 72 weeks |
| Peak time (Tmax) | Time to peak blood concentration after a single dose. | Day1 0 hour pre-dose,10,20,30minutes,1,2,3,6,12,24,48 hours after dose, Day15 within 60 minutes pre-dose, Day29 0h pre-dose,10, 20, 30 minutes, 1,2,3,6,12,24,48 hours after dose, Day57 and Day85 0hour pre-dose |
| Peak Concentration | The highest plasma drug concentration that can be achieved after medication. | Day1 0 hour pre-dose,10,20,30minutes,1,2,3,6,12,24,48 hours after dose, Day15 within 60 minutes pre-dose, Day29 0h pre-dose,10, 20, 30 minutes, 1,2,3,6,12,24,48 hours after dose, Day57 and Day85 0hour pre-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. | Day1 0 hour pre-dose,10,20,30minutes,1,2,3,6,12,24,48 hours after dose, Day15 within 60 minutes pre-dose, Day29 0h pre-dose,10, 20, 30 minutes, 1,2,3,6,12,24,48 hours after dose, Day57 and Day85 0hour pre-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 | Day1 0 hour pre-dose,10,20,30minutes,1,2,3,6,12,24,48 hours after dose, Day15 within 60 minutes pre-dose, Day29 0h pre-dose,10, 20, 30 minutes, 1,2,3,6,12,24,48 hours after dose, Day57 and Day85 0hour pre-dose |
| Plasma clearance | How many milliliters of plasma can the kidneys completely clear in unit time (per minute) | Day1 0 hour pre-dose,10,20,30minutes,1,2,3,6,12,24,48 hours after dose, D15 within 60 minutes pre-dose, Day29 0h pre-dose,10, 20, 30 minutes, 1,2,3,6,12,24,48 hours after dose, D57 and D85 0hour pre-dose. |
| Elimination half-life time | The time it takes for the plasma concentration to drop by half. | Day1 0 hour pre-dose,10,20,30minutes,1,2,3,6,12,24,48 hours after dose, Day15 within 60 minutes pre-dose, Day29 0h pre-dose,10, 20, 30 minutes, 1,2,3,6,12,24,48 hours after dose, Day57 and Day85 0hour pre-dose |
| Peaking Time | The time required to reach peak steady-state concentration after administration. | Day1 0 hour pre-dose,10,20,30minutes,1,2,3,6,12,24,48 hours after dose, D15 within 60 minutes pre-dose, Day29 0h pre-dose,10, 20, 30 minutes, 1,2,3,6,12,24,48 hours after dose, D57 and D85 0hour pre-dose. |
| Steady state maximum concentration | The highest blood concentration that occurs after stabilization. | Day1 0 hour pre-dose,10,20,30minutes,1,2,3,6,12,24,48 hours after dose, Day15 within 60 minutes pre-dose, Day29 0h pre-dose,10, 20, 30 minutes, 1,2,3,6,12,24,48 hours after dose, Day57 and Day85 0hour pre-dose |
| Steady state minimal concentration | The lowest blood concentration that occurs after stabilization | Day1 0 hour pre-dose,10,20,30minutes,1,2,3,6,12,24,48 hours after dose, Day15 within 60 minutes pre-dose, Day29 0h pre-dose,10, 20, 30 minutes, 1,2,3,6,12,24,48 hours after dose, Day57 and Day85 0hour pre-dose |
| Area under steady-state blood concentration-time curve | After the dosage of a single agent, the amount of dosage of the blood circulation of the person can be used with blood concentration-the area of the area under the time curve. | Day1 0 hour pre-dose,10,20,30minutes,1,2,3,6,12,24,48 hours after dose, Day15 within 60 minutes pre-dose, Day29 0h pre-dose,10, 20, 30 minutes, 1,2,3,6,12,24,48 hours after dose, Day57 and Day85 0hour pre-dose |
| The Third Affiliated Hospital of Sun Yat-sen University |
| Guangzhou |
| Guangdong |
| 510000 |
| China |
| Peking University Shenzhen Hospital | Shenzhen | Guangdong | 518036 | China |
| Hospital workers in Liuzhou | Liuzhou | Guangxi | 545000 | China |
| WuHan Jinyintan Hospital | Wuhan | Hubei | 430023 | China |
| The Second XIANGYA Hospital Of Central South University | Changsha | Hunan | 410008 | China |
| The Fifth People's Hospital of Wuxi (Affiliated Wuxi Fifth Hospital of Jiangnan University) | Wuxi | Jiangsu | 214001 | China |
| The first hospital of Jilin University | Changchun | Jilin | 130021 | China |
| The Sixth People's Hospital of Shenyang | Shenyang | Liaoning | 110000 | China |
| The First Affiliated Hospital of Xi'an Jiao Tong University | Xi'an | Shaanxi | 710000 | China |
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610044 | China |
| The First Affiliated Hospital of Xinjiang Medical University | Ürümqi | Xinjiang | 831400 | China |
| First People's Hospital of Yunnan Province | Kunming | Yunnan | 650034 | China |
| Pu'er People's Hospital | Pu'er | Yunnan | 665099 | China |
| People's Hospital Of RuiAn City | Rui’an | Zhejiang | 325200 | China |
| 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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| ID | Term |
|---|---|
| D009705 | Nucleosides |
| D000143 | Acids |
| ID | Term |
|---|---|
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D007287 | Inorganic Chemicals |
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