chronic hepatitis B
Conditions
Interventions
de novo combination therapy:Lamivudine 100mg po qd, Adefovir Dipivoxil 10mg po qd, for 96 weeks
monotherapy:Entecvir 0.5mg po qd, for 96 weeks
Sponsors
Departmen of infectious disease, Tongji Hospital, Tongji medical college, Huazhong university of science and technology
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Male and female aged 18 to 65 years old; 2. Patients with chronic hapatitis B, and (1) Both Serum HBsAg and HBeAg positive for at least 6 months before srceening; (2) Serum HBV DNA level >=107copies/mL at screening; (3) ALT>=2*ULN and <10*ULN at screening (excluding other known risk factors for abnormal ALT, such as drug, alcohol abuse, etc.); 3. Patients compliant well with the treatment.
Exclusion criteria
Exclusion criteria: 1. HBV-related medical history: (1) Emergence of serum rtL180M, rtA181T/V, rtM204I/V or rtN236T mutation at screening; (2) Receiving any treatment with nucleoside/nucleotide analogues (NAs) before screening; (3) Receiving any treatment with IFN or immunomodulator (including IFN,Thymosin,IL-12,etc.); 2. HBV-related disease: (1) Patients with history and any symptom or sign of liver decompensation; (2) Patients with history of hepatocellular carcinoma (HCC) or related symptoms, like suspicious nodules, increasing AFP level; (3) Patients with cirrhosis; (4) Patients with evidence of other significant liver diseases including a history of autoimmune hepatitis, alcoholic liver disease, secondary liver cancer, etc; (5) Patients coinfected with HAV,HCV,HDV,HEV or HIV; 3. Abnormal laboratory test results: (1) Hb: male=40umol/L; (7) Cr>=1*ULN; (8) PT prolong>=3s or PTA=50 ng/mL; 4. Other related factors: (1) Patients receiving treatment of systemic corticosteroids, except for topical use or inhalation therapy; (2) Patients receiving any treatment with hepatotoxic drugs (dapsone, erythromycin, fluconazole, ketoconazole, rifampicin or other anti-TB agents) within 1 month before screening. 5. general exclusion criteria: (1) Patients with history of cancer of other organs within 5 years; (2) Patients with alcohol consumption > 40g/d, or illegal drug-abuse within one year; (3) Pregnant or lactating women; (4) Female or male of childbearing age can not take effective contraceptive methods.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBV DNA testin; | — |
Secondary
| Measure | Time frame |
|---|---|
| quantitative determination of serum HBV markers;detection of drug resistance mutation in HBV; | — |
Countries
China
Contacts
Public ContactQin Ning
Outcome results
None listed