Oxymatrine Plus Lamivudine Combination Therapy Versus Lamivudine Monotherapy for Chronic Hepatitis B Infected Subjects
NCT ID: NCT02202473
Last Updated: 2014-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
192 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lamivudine
Lamivudine (Manufacturer: GlaxoSmithKline) 100mg po, qd
Lamivudine
Lamivudine+Oxymatrine Capsules
Lamivudine (Manufacturer: GlaxoSmithKline) 100mg po, qd; oxymatrine Capsules (Chia Tai Tianqing Pharmaceutical Group Co., Ltd) 200 mg, po, tid.
Lamivudine+Oxymatrine Capsules
Interventions
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Lamivudine
Lamivudine+Oxymatrine Capsules
Eligibility Criteria
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Inclusion Criteria
2. Subjects diagnosed as chronic hepatitis B according to 2000 Xi'an Conference Guidelines: Management of chronic hepatitis B. Alanine transaminase \>80 IU/L, total bilirubin\<85.5 mmol/L, Hepatitis B virus DNA \>1×10\^5copies/mL; haven't been treated with antiviral therapy within 6 months before screening.
3. able to give written informed consent and to comply with the study protocol.
4. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study.
Exclusion Criteria
2. Clinical symptoms of Decompensated liver disease at screening, including but not limited to: Serum bilirubin≥1.5 x upper limit of normal, prothrombin time of greater than 2 seconds prolonged, a serum albumin\< 32g/L, or a history of ascites, variceal bleeding, or hepatic encephalopathy;
3. Alanine transaminase\>10 x upper limit of normal at screening or history of Transient hepatic decompensation caused by acute exacerbation;
4. hemoglobin\< 10g/dL, Neutrophil count\<1.5 × 10\^9/L, platelet count\< 80 × 10\^9/L;
5. Evidence of active liver disease from other causes, including co-infection with hepatitis A virus, co-infection with hepatitis E virus, co-infection with hepatitis C virus, co-infection with hepatitis D virus, co-infection with HIV, autoimmune hepatitis (antinuclear antibody titer\> 1:100);
6. Use of immunosuppressors, immunomodulators (including interferon or thymosin) within 6 months before enrollment.
18 Years
60 Years
ALL
No
Sponsors
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Cttq
INDUSTRY
Southeast University, China
OTHER
Responsible Party
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Wei Zhao
director of the hospital
Locations
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the second hospital of Nanjing
Nanjing, Jiangsu, China
Countries
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References
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Lu FM, Zhuang H. Management of hepatitis B in China. Chin Med J (Engl). 2009 Jan 5;122(1):3-4. No abstract available.
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.
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.
Other Identifiers
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Oxymatrine
Identifier Type: -
Identifier Source: org_study_id
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