Oxymatrine Plus Lamivudine Combination Therapy Versus Lamivudine Monotherapy for Chronic Hepatitis B Infected Subjects

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southeast University, China
• Collaborator: Cttq
• Treatments: Lamivudine; Oxymatrine

Criteria

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.