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Per sponsor request. Premature closure was not prompted by any safety or efficacy concerns.
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This is a multicenter, randomized, double-blind, placebo-controlled phase II study, in which all participants are required to use TQA3605 tablets/placebo in combination with entecavir. The purpose is to evaluate the efficacy and safety of TQA3605 tablets combined with entecavir in treatment-naive chronic HBV-infected subjects. A total of 215 subjects are required.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 100mg TQA3605 tablets + entecavir (ETV) (PART A) | Experimental | Patients aged 30-65 years old group:TQA3605 tablets, 100mg once a day, orally for 48 weeks in combination with entecavir, followed by treatment with entecavir for 24 weeks |
|
| 200mg TQA3605 tablets +ETV (PART A) | Experimental | Patients aged 30-65 years old group:TQA3605 tablets, 200mg once a day, orally for 48 weeks in combination with entecavir, followed by treatment with entecavir for 24 weeks |
|
| TQA3605 tablets Placebo +ETV (PART A) | Placebo Comparator | Patients aged 30-65 years old group: TQA3605 tablets placebo, once a day, orally for 48 weeks in combination with entecavir, followed by treatment with entecavir for 24 weeks. |
|
| 200mg TQA3605 tablets +ETV (PART B) | Experimental | Patients aged 18-30 years old group:TQA3605 tablets, 200mg once a day, orally for 48 weeks in combination with entecavir, followed by treatment with entecavir for 24 weeks. |
|
| TQA3605 tablets Placebo +ETV (PART B) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQA3605 tablets Placebo | Drug | Placebo contains no active substance. |
|
| Measure | Description | Time Frame |
|---|---|---|
| hepatitis B virus (HBV) DNA <10 IU/mL | Percentage of subjects with HBV DNA below the lower limit of quantification (<10 IU/mL) after 48 weeks of treatment. | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects with HBV DNA<10 IU/mL | Percentage of subjects with HBV DNA<10 IU/mL at week 12, 24, 36, 60, and 72 | 12 weeks, 24 weeks, 36 weeks, 60 weeks, 72 weeks |
| Percentage of HBV DNA<20 IU/mL |
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Inclusion Criteria:
Exclusion 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 University |
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Patients aged 18-30 years old group:TQA3605 tablets Placebo taken once a day, orally for 48 weeks in combination with entecavir, followed by treatment with entecavir for 24 weeks. |
|
| TQA3605 Tablets | Drug | TQA3605 tablets is core protein allosteric modulators |
|
| Entecavir dispersible tablets | Drug | Entecavir dispersible tablets is an inhibitor of hepatitis B virus replication. |
|
Percentage of subjects with HBV DNA<20 IU/mL at weeks 12, 24, 36, 48, 60, and 72 of treatment.
| 12 weeks, 24 weeks, 36 weeks, 48weeks, 60 weeks, 72 weeks |
| Percentage of subjects with HBeAg serologic clearance and/or serologic conversion | Percentage of subjects with HBeAg serologic clearance and/or serologic conversion | 24weeks, 48 weeks, 72 weeks |
| Alanine aminotransferase(ALT)≤The upper limit of the normal reference value (ULN) | The rate of ALT normalization at weeks 24, 48, and 72 of treatment | 24weeks, 48 weeks, 72 weeks |
| Virology breakthrough percentage | Percentage of subjects who experienced virological breakthroughs at weeks 24, 48, and 72 of treatment | 24weeks, 48 weeks, 72 weeks |
| Actual values of HBV markers and changes over time relative to baseline | Actual values of HBsAg, HBeAg, HBV DNA, HBV RNA, and Hepatitis B core-related antigen (HBcrAg) at each visit time point and their changes over time relative to baseline. | 12 weeks, 24 weeks, 36 weeks, 48 weeks, 72 weeks |
| Adverse events (AE) | The incidence and severity of adverse events. | 72 weeks |
| Steady state minimum concentration (Cmin,ss) | Cmin,ss of TQA3605 and its metabolite | 48 weeks |
| Beijing |
| Beijing Municipality |
| 100069 |
| China |
| The Second Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | 400010 | China |
| The Southwest Hospital of AMU | Chongqing | Chongqing Municipality | 400038 | China |
| Mengchao Hepatobiliary Hospital of Fujian Medical University | Fuzhou | Fujian | 350025 | China |
| NanFang Hospital | Guangzhou | Guangdong | 510515 | China |
| Peking University Shenzhen Hospital | Shenzhen | Guangdong | 518036 | China |
| The First Affiliated Hospital of GUANGXI Medical University | Nanning | Guangxi | 530021 | China |
| Hebei Medical University Third Hospital | Shijiazhuang | Hebei | 050000 | China |
| Zhengzhou No.6 peoples Hospital | Zhengzhou | Henan | 450000 | China |
| Henan Provincial People's Hospital | Zhengzhou | Henan | 450002 | China |
| The First Hospital of Changsha | Changsha | Hunan | 410005 | China |
| Jiangsu Provincial People's Hospital | Nanjing | Jiangsu | 210003 | China |
| The Second Hospital of Nanjing | Nanjing | Jiangsu | 210003 | China |
| Naniing Drum Tower Hospital | Nanjing | Jiangsu | 210008 | China |
| The Fifth People's Hospital of Suzhou | Suzhou | Jiangsu | 215131 | China |
| The Fifth People's Hospital of Wuxi | Wuxi | Jiangsu | 214061 | China |
| Zhenjiang Third People's Hospital | Zhenjiang | Jiangsu | 212004 | China |
| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330000 | China |
| The First Hospital of Jilin University | Changchun | Jilin | 130021 | China |
| Shengjing Hospital Affiliated to China Medical University | Shenyang | Liaoning | Liaoning | China |
| The First Affiliated Hospital of Xi'an Jiao Tong University | Xi'an | Shaanxi | 710000 | China |
| Xi'an Jiaotong University Second Affiliated Hospital | Xi'an | Shaanxi | 710000 | China |
| The Second Hospital of Shandong University | Jinan | Shandong | 250033 | China |
| Shandong Provincial Clinical Center for Public Health | 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 Xinjiang Medical University | Ürümqi | Xinjiang | 830013 | China |
| Yiwu Central Hospital | Yiwu | Zhejiang | 322099 | 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 |
|---|---|
| C413685 | entecavir |
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