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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQA3605 Placebo plus NAs | Placebo Comparator | TQA3605 placebo plus NAs drug was administered for 24 weeks and NAs was continued until 32 weeks |
|
| 100mg TQA3605 tablets plus NAs | Experimental | 100mg TQA3605 tablets plus NAs drug was administered for 24 weeks and NAs was continued until 32 weeks |
|
| 200mg TQA3605 tablets plus NAs | Experimental | 200mg TQA3605 tablets plus NAs drug was administered for 24 weeks and NAs was continued until 32 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQA3605 tablets plus NAs | Drug | TQA3605 tablets is core protein regulator |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 32 weeks |
| Incidence and severity of serious adverse events (SAEs) |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Ditan Hospital Capital Medical University | Beijing | Beijing Municipality | 100015 | China | ||
| Beijing Youan Hospital, Capital Medical Universitybeijing Institute of Hepatology |
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| TQA3605 Placebo plus NAs | Drug | Placebo without drug substance |
|
The incidence and severity of SAEs were determined by changes in physical examination, vital signs, electrocardiogram, and laboratory tests |
| 32 weeks |
| HBV DNA (<10 IU/mL) | Percentage of subjects with HBV DNA below the lower limit of quantitative detection (<10 IU/mL) | 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) | 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) | 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 | Weeks 12, Weeks 24, Weeks 32 |
| Breakthroughs in virology | Percentage of subjects with a virological breakthrough | 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 | Weeks 12, Weeks 24, Weeks 32 |
| Actual values and changes of HBeAg | Actual values and changes of HBeAg over time relative to baseline | 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 | 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 | 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 | Weeks 12, Weeks 24, Weeks 32 |
| (Cmax, ss) Steady-state maximum concentration | Steady-state maximum concentration of TQA3605 | Day 1, Day 29, Day 57, Day 85, Day 113, Day 169 |
| (Cmin, ss) Steady state minimum concentration | Steady-state minimum concentration of TQA3605 | Day 1, Day 29, Day 57, Day 85, Day 113, Day 169 |
| Beijing |
| Beijing Municipality |
| 100054 |
| China |
| Meng Chao Hepatobiliary Hospital of Fujian Medical University | Fuzhou | Fujian | 350001 | China |
| Peking University Shenzhen Hospital | Shenzhen | Guangdong | 518036 | China |
| Guizhou Provincial People's Hospital | Guiyang | Guizhou | 550002 | China |
| Zunyi Medical University Affiliated Hospital | Zunyi | Guizhou | 563000 | China |
| Zhengzhou No.6 peoples Hospital | Zhengzhou | Henan | 450000 | China |
| The Second XIANGYA Hospital Of Central South University | Changsha | Hunan | 410008 | China |
| Yueyang Central Hospital | Yueyang | Hunan | 414000 | China |
| Jiangsu Provincial People's Hospital | Nanjing | Jiangsu | 210000 | China |
| The Fifth People's Hospital of Suzhou | Suzhou | Jiangsu | 215131 | China |
| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330000 | China |
| The sixth people's Hospital Of Shenyang | Shenyang | Liaoning | 110001 | China |
| Shandong Public Health Clinical Center | Jinan | Shandong | 250102 | China |
| Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | 200000 | China |
| Shanghai Tongren Hospital | Shanghai | Shanghai Municipality | 200336 | China |
| The First Affiliated Hospital of Xi'an Jiao Tong University | Xi’an | Shanxi | 710000 | China |
| The First Affiliated Hospital Zhejiang University School Of Medicine | Hangzhou | Zhejiang | 310006 | China |
| Lishui People's Hospital | Lishui | Zhejiang | 323000 | China |
| ID | Term |
|---|---|
| C015378 | nas |
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