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| Name | Class |
|---|---|
| Major Science and Technology Special Project of China Eleventh Five-year | OTHER |
| Novartis | INDUSTRY |
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ROADMAP | Experimental |
| |
| SOC (Standard of Care) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| telbivudine (ROADMAP) | Drug | Patients will receive oral telbivudine 600mg, daily for 104 weeks, if HBV DNA breakthrough, add on oral adefovir 10mg daily Stopping rules: The participants who achieve HBeAg seroconversion and HBV DNA<300copies/ml with over 12 months consolidation treatment in EFFORT study will discontinue treatment. The participants who don't meet the rules above will continue their previous treatment and follow up at the interval of 12 weeks until they finish the 156 weeks therapy or achieve the stopping rules. Follow up： The participants who stopped treatment will follow up at the interval of 12 weeks for 52 weeks. Of these patients, if they have confirmed virologic relapse during follow-up period, they will be excluded from the trial. |
| Measure | Description | Time Frame |
|---|---|---|
| The difference of percentage of patients achieving HBV DNA< 300copies/mL at week 48 in Group I and Group II | Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients achieving HBV DNA <300copies/mL at week 156 | Week 156 | |
| The log10 reduction in HBV DNA from baseline of EFFORT study at week 156 | Week 156 | |
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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 |
|---|---|---|---|---|---|---|
| 302 Military Hospital Of China | Beijing | Beijing Municipality | China | |||
| Beijing Ditan Hospita |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077712 | Telbivudine |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D013936 | Thymidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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|
| Telbivudine (Standard of Care) | Drug | Patients will receive oral telbivudine 600mg, daily for 104 weeks, if HBV DNA breakthrough, add on oral adefovir 10mg daily Stopping rules: The participants who achieve HBeAg seroconversion and HBV DNA<300copies/ml with over 12 months consolidation treatment in EFFORT study will discontinue treatment. The participants who don't meet the rules above will continue their previous treatment and follow up at the interval of 12 weeks until they finish the 156 weeks therapy or achieve the stopping rules. Follow up： The participants who stopped treatment will follow up at the interval of 12 weeks for 52 weeks. Of these patients, if they have confirmed virologic relapse during follow-up period, they will be excluded from the trial. |
|
| Percentage of patients with HBeAg loss or HBeAg seroconversion at week 156 |
| Week 156 |
| Percentage of patients with HBsAg loss or HBsAg seroconversion at week 156 | Week 156 |
| The percentage of patients with ALT normalization at week 156 | Week 156 |
| Percentage of patients with HBV DNA breakthrough at week 156 | Week 156 |
| Percentage of patients with genotypic resistance among the patients with HBV DNA breakthrough at week 156 | Week 156 |
| sustained response rate of durability of HBeAg seroconversion at week 52 of off-treatment duration | week 52 of off-treatment |
| percentage of hepatitis flare at week 52 of off-treatment duration | week 52 of off-treatment |
| Beijing |
| Beijing Municipality |
| China |
| Beijing Friendship Hospital Attached To The Capital Medical University | 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 |
| Department of Infectious Disease, Nanfang Hospital | Guangzhou | Guangdong | China |
| No. 8 People's Hospital In GuangZhou | Guangzhou | Guangdong | China |
| The Third Hospital of Sun Yat-Sen University | Guangzhou | Guangdong | 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 |
| No.81 Hospital of PLA | Nanjing | Jiangsu | China |
| First Hospital .Jilin Unniversity | Changchun | Jilin | China |
| ShengJing Hospital of China Medical University | Shengyang | 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 |
| The First Affiliated Hospital of College of Medicine, Zhejiang University | Hangzhou | Zhejiang | China |
| The Sixth People's Hospital of Hangzhou | Hangzhou | Zhejiang | China |
| 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 |
| D006571 |
| Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |