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| Name | Class |
|---|---|
| JiangSu Chia-Tai Tianqin Pharmacy Co.Ltd | UNKNOWN |
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The purpose of this study is to evaluate the efficacy and safety of generic entecavir monotherapy or in combination with adefovir for chronic hepatitis B patients with inadequate response to NUC therapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | oral entecavir 1mg daily for 104 weeks |
|
| B | Active Comparator | oral entecavir 1mg daily and adefovir 10mg daily for 104 weeks |
|
| C | Active Comparator | oral entecavir 0.5mg daily and adefovir 10mg daily for 104 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entecavir | Drug | patients will receive oral entecavir 1mg, daily for 104 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| proportion of subjects with hepatitis B virus (HBV)DNA<300copies/ml at week 104 | week 104 |
| Measure | Description | Time Frame |
|---|---|---|
| serum HBV DNA reduction from baseline at week 104 | week 104 | |
| The proportion of subjects with ALT normalization at week 104 | week104 | |
| The proportion of subjects with HBeAg loss and seroconversion at week 104 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| JinLin Hou, MD | Nanfang Hospital, Southern Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Ditan Hospita | Beijing | Beijing Municipality | China | |||
| Beijing Friendship Hospital Attached to the Capital Medical University |
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| Entecavir, Adefovir |
| Drug |
patients in this arm will receive oral entecavir 1mg daily and adefovir 10mg daily for 104 weeks |
|
| Entecavir, Adefovir | Drug | patients in this arm will receive oral entecavir 0.5mg daily and adefovir 10mg daily for 104 weeks |
|
| week104 |
| The proportion of subject with HBsAg loss and seroconversion at week 104 | week104 |
| The proportion of subjects with mutations of rtN236T/A181V, rtL180M/rtM204V/rtT184/rtS202 and/or rtM250 at week 104 | week104 |
| Beijing |
| Beijing Municipality |
| China |
| Department of infectious disease, First Hospital of Peking University | Beijing | Beijing Municipality | China |
| People'S Hospital Under Beijnig University | Beijing | Beijing Municipality | China |
| The First Affiliated Hospital of Fujian Medical University | Fuzhou | Fujian | China |
| The First People's Hospital of Foshan | Foshan | Guangdong | China |
| Department of infectious disease, Nanfang Hospital | Guangzhou | Guangdong | China |
| GuangDong Provincial People's hospital | Guangzhou | Guangdong | China |
| First Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi | China |
| Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology | Wuhan | Hubei | China |
| Xiangya Hospital Central-South Univrsity | Changsha | Hunan | China |
| First Hospital .Jilin Unniversity | Changchun | Jilin | China |
| ShengJing Hospital of China Medical University | Shenyang | Liaoning | China |
| Changhai Hospital affiliated to Second Military Medical University | Shanghai | Shanghai Municipality | China |
| Huashan Hospital,Fudan University | Shanghai | Shanghai Municipality | China |
| Shanghai Ruijin Hospital | Shanghai | Shanghai Municipality | China |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006521 | Hepatitis, Chronic |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C413685 | entecavir |
| C053001 | adefovir |
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