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

Southeast University, China

Status and phase

Completed

Phase 4

Conditions

Chronic Hepatitis B

Treatments

Drug: Lamivudine+Oxymatrine Capsules

Drug: Lamivudine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02202473

Oxymatrine

Details and patient eligibility

About

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.

Full 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.

Enrollment

192 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

18 to 60 years old.
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.
able to give written informed consent and to comply with the study protocol.
Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study.

Exclusion criteria

Evidence of hepatocellular carcinoma
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;
Alanine transaminase>10 x upper limit of normal at screening or history of Transient hepatic decompensation caused by acute exacerbation;
hemoglobin< 10g/dL, Neutrophil count<1.5 × 10^9/L, platelet count< 80 × 10^9/L;
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);
Use of immunosuppressors, immunomodulators (including interferon or thymosin) within 6 months before enrollment.