Chronic Hepatitis B
Conditions
Keywords
Oxymatrine Capsules, lamivudine, chronic Hepatitis B
Brief summary
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.
Detailed description
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.
Interventions
DRUGLamivudine
DRUGLamivudine+Oxymatrine Capsules
Sponsors
Cttq
Southeast University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. 18 to 60 years old. 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
1. Evidence of hepatocellular carcinoma 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.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Hepatitis B virus resistance loci | 1, 3, 6, 12, 15, 18 months |
Countries
China
Outcome results
None listed