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| Name | Class |
|---|---|
| Cttq | INDUSTRY |
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The purpose of this study is to evaluate the efficacy of Oxymatrine plus Lamivudine Combination Therapy and whether it could lower the incidence of Lamivudine long-term resistance compared to Lamivudine Monotherapy.
Group A (Lamivudine Monotherapy): Lamivudine (Manufacturer: GlaxoSmithKline) 100mg po, qd.
Group B (Oxymatrine + Lamivudine Combination Therapy): Lamivudine (Manufacturer: GlaxoSmithKline) 100mg po, qd; oxymatrine Capsules (Chia Tai Tianqing Pharmaceutical Group Co., Ltd) 200 mg, po, tid.
Total subjects: 200, 100 patients randomized in each group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lamivudine | Active Comparator | Lamivudine (Manufacturer: GlaxoSmithKline) 100mg po, qd |
|
| Lamivudine+Oxymatrine Capsules | Experimental | Lamivudine (Manufacturer: GlaxoSmithKline) 100mg po, qd; oxymatrine Capsules (Chia Tai Tianqing Pharmaceutical Group Co., Ltd) 200 mg, po, tid. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lamivudine | Drug |
| ||
| Lamivudine+Oxymatrine Capsules |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of Hepatitis B virus DNA titer compared to Baseline Hepatitis B virus DNA titer every 3 months for 18 months | 1, 3, 6, 12, 15, 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Hepatitis B virus resistance loci | 1, 3, 6, 12, 15, 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the second hospital of Nanjing | Nanjing | Jiangsu | 210000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19187608 | Background | Lu FM, Zhuang H. Management of hepatitis B in China. Chin Med J (Engl). 2009 Jan 5;122(1):3-4. No abstract available. | |
| 19324298 | Background | Yuen MF, Fung J, Wong DK, Lai CL. Prevention and management of drug resistance for antihepatitis B treatment. Lancet Infect Dis. 2009 Apr;9(4):256-64. doi: 10.1016/S1473-3099(09)70056-8. |
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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 |
|---|---|
| D019259 | Lamivudine |
| ID | Term |
|---|---|
| D016047 | Zalcitabine |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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|
| 21277330 | Background | Wang YP, Zhao W, Xue R, Zhou ZX, Liu F, Han YX, Ren G, Peng ZG, Cen S, Chen HS, Li YH, Jiang JD. Oxymatrine inhibits hepatitis B infection with an advantage of overcoming drug-resistance. Antiviral Res. 2011 Mar;89(3):227-31. doi: 10.1016/j.antiviral.2011.01.005. Epub 2011 Jan 28. |
| 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 |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D015224 | Dideoxynucleosides |