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| Name | Class |
|---|---|
| Major Science and Technology Special Project of China Eleventh Five-year | OTHER |
| Novartis | INDUSTRY |
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The purpose of this trial is to prove that the strategy of treatment adjustment at W24 according to virological response based on ROADMAP concept is better than standard of care strategy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ROADMAP Group (Group I) | Experimental | Patients were to take telbivudine 600 mg orally daily from Baseline.At Week 24, patients in Group I were split into Group I-A or Group I-B based on their virologic load:
The total treatment duration was 104 weeks. |
|
| SOC (Standard of Care) Group (Group II) | Active Comparator | patients were to take telbivudine 600 mg monotherapy from Baseline until Week 104. If viral breakthrough (defined as HBV DNA 1 log10 above nadir) was confirmed (by two examinations with at least a 1 month interval with compliance factor excluded), adefovir 10 mg daily was to be added. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| telbivudine | Drug | telbivudine, 600mg, oral, daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate the percentage of patients achieving HBV DNA< 300copies/mL at Week 104 in Group I is superior than that in Group II | Week 104 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients achieving HBV DNA <60IU/mL (300copies/mL) at Week 52 | week 52 | |
| Serum HBV DNA reduction from baseline at week 104 | week 104 | |
| Percentage of patients with HBeAg loss & HBeAg seroconversion at week104 in patients with HBeAg positive at baseline |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17632041 | Background | Keeffe EB, Zeuzem S, Koff RS, Dieterich DT, Esteban-Mur R, Gane EJ, Jacobson IM, Lim SG, Naoumov N, Marcellin P, Piratvisuth T, Zoulim F. Report of an international workshop: Roadmap for management of patients receiving oral therapy for chronic hepatitis B. Clin Gastroenterol Hepatol. 2007 Aug;5(8):890-7. doi: 10.1016/j.cgh.2007.05.004. Epub 2007 Jul 13. | |
| 32189364 |
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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 |
| ID | Term |
|---|---|
| D013936 | Thymidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| telbivudine | Drug | telbivudine, 600mg, oral, daily |
|
|
| week 104 |
| Percentage of patients with HBV DNA<300copies/mL AND HBeAg loss or seroconversion at Week 104 in patients with positive HBeAg at baseline | week 104 |
| Serum HBV DNA reduction from baseline at week 52 | week 52 |
| 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 | 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 |
| The First Affiliated Hospital of College of Medicine ，Zhejiang University | Hangzhou | Zhejiang | China |
| The Sixth People's Hospital of Hangzhou | Hangzhou | Zhejiang | China |
| Huang Q, Zhou B, Cai D, Zong Y, Wu Y, Liu S, Mercier A, Guo H, Hou J, Colonno R, Sun J. Rapid Turnover of Hepatitis B Virus Covalently Closed Circular DNA Indicated by Monitoring Emergence and Reversion of Signature-Mutation in Treated Chronic Hepatitis B Patients. Hepatology. 2021 Jan;73(1):41-52. doi: 10.1002/hep.31240. Epub 2020 Dec 1. |
| 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 |