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| Name | Class |
|---|---|
| Major Science and Technology Special Project of China Eleventh Five-year | OTHER |
| GlaxoSmithKline | INDUSTRY |
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The purpose of this study is to compare the adefovir early add-on to rescue therapy strategy, and also explore the efficacy of Lamivudine and adefovir de-novo combination therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| early add-on | Experimental |
| |
| SOC | Active Comparator | Patients will receive oral lamivudine 100mg,daily for 104 weeks, if HBV DNA breakthrough, add on oral adefovir 10mg daily |
|
| De-novo combination | Other | patients in this arm will receive oral lamivudine 100mg and adefovir 10mg for 104 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lamivudine | Drug | patients in this arm will receive oral lamivudine 100mg,daily for 24 weeks; if patients with HBV DNA higher than 1000 copies/ml at week 24, add on adefovir to week 104; otherwise, keep lamivudine monotherapy to week 104 |
| Measure | Description | Time Frame |
|---|---|---|
| the proportion of virological breakthrough with confirmed Lamivudine resistant mutants | during 104 weeks study period |
| Measure | Description | Time Frame |
|---|---|---|
| proportion of subjects with hepatitis B virus (HBV) DNA≤300 copies/mL | week 104 | |
| Reduction of serum HBV DNA level from baseline (log10 copies/mL) to week 104 | baseline, 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27650283 | Derived | Xiang KH, Michailidis E, Ding H, Peng YQ, Su MZ, Li Y, Liu XE, Dao Thi VL, Wu XF, Schneider WM, Rice CM, Zhuang H, Li T. Effects of amino acid substitutions in hepatitis B virus surface protein on virion secretion, antigenicity, HBsAg and viral DNA. J Hepatol. 2017 Feb;66(2):288-296. doi: 10.1016/j.jhep.2016.09.005. Epub 2016 Sep 17. |
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| lamivudine | Drug | Patients will receive oral lamivudine 100mg,daily for 104 weeks, if HBV DNA breakthrough, add on oral adefovir 10mg daily |
|
| lamivudine, adefovir | Drug | patients in this arm will receive oral lamivudine 100mg daily and adefovir 10mg for 104 weeks |
|
| The proportion of subjects with ALT normalization at week 104 |
| week 104 |
| The proportion of subjects with HBeAg loss and seroconversion at week 104 | week 104 |
| The proportion of subjects with HBsAg loss and seroconversion rates at week 104 | week 104 |
| Beijing |
| Beijing Municipality |
| China |
| BeiJing YouAn Hospital ,Capital Medical University | 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 Second Affiliated of ChongQing University of Medical Science | Chongqing | Chongqing 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 |
| JiNan Infectious Diseases Hospital | Jinan | Shandong | China |
| Changhai Hospital affiliated to Second Military Medical University | Shanghai | Shanghai Municipality | China |
| Huashan Hospital，Fudan University | Shanghai | Shanghai Municipality | China |
| No.85 Hospital of PLA | Shanghai | Shanghai Municipality | China |
| Shanghai Ruijin Hospital | Shanghai | Shanghai Municipality | China |
| Tangdu Hospital | XiAn | Shanxi | China |
| West China Hospital.SiChuan University | Chengdu | Sichuan | China |
| HangZhou No.6 People Hospital | Hangzhou | Zhejiang | China |
| The First Affiliated Hospital of College of Medicine ，Zhejiang University | Hangzhou | Zhejiang | 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 |
|---|---|
| D019259 | Lamivudine |
| C053001 | adefovir |
| ID | Term |
|---|---|
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |
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