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| Name | Class |
|---|---|
| Major Science and Technology Special Project of China Eleventh Five-year | OTHER |
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The purpose of this study is to compare the long-term efficacy and safety of entecavir 1.0 mg/d + adefovir 10 mg/d with entecavir 0.5 mg/d + adefovir 10 mg/d for chronic hepatitis B patients with inadequate response to NUC therapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I | Active Comparator | oral entecavir 1mg daily and adefovir 10mg daily for 144 weeks |
|
| Group II | Active Comparator | oral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entecavir, Adefovir | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentages of patients achieving HBV DNA< 300copies/mL at week 144 in each group | Week 144 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentages of patients achieving HBV DNA <300copies/mL at week 48/96 in each group. | Week 48 & 96 | |
| The log10 reduction in HBV DNA from baseline of DRAGON study at week 48/96/144. | Week 48 & 96 &144 |
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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 Hospital | Beijing | Beijing Municipality | China | |||
| Beijing Friendship Hospital Attached To The Capital Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33500704 | Derived | Li Y, Pan CQ, Ji S, Yan G, Cheng J, Liu S, Xing H. Serum IL-21 levels predict HBeAg decline during rescue therapy in patients with partial response to nucleos(t)ide analogues. Exp Ther Med. 2021 Mar;21(3):216. doi: 10.3892/etm.2021.9648. Epub 2021 Jan 15. |
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| Percentage of patients with HBeAg loss or HBeAg seroconversion at week 48/96/144. | Week 48 & 96 & 144 |
| Percentage of patients with ALT normalization at week 48/96/144 | Week 48 & 96 & 144 |
| 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 | Shengyang | 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 |
|---|---|
| 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 |
| C053001 | adefovir |
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