Chronic Hepatitis B
Conditions
Interventions
Group 3:Giving adefovir only
Group 1:Giving adefovir and lamivudine together
Group 2:Treated by Lamivudine for 16 weeks and combined with Adefovir when the HBV-DNA >1000 copies/ml
Sponsors
The First Affiliated Hospital of Wenzhou Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients with chronic hepatitis B: (1) HBsAg positive more than 6 months; (2) HBV-DNA > 100,000copies/ml and ALT levels 2-10 times the upper limit of normal (ULN) in HBeAg positive, and with HBV-DNA > 10,000 copies/ml and ALT levels 1. 3-10 times the upper limit of normal (ULN) in HBeAg negative. 2. Patients have compensated liver function with total serum bilirubin<=2ULN; prothrombin time<=3 seconds; serum albumin and creatinine within the normal range; 3. alpha-fetoprotein (AFP) <100ng/mL, when the level of AFP is during 50-100ng/mL, ultrasound examination should be taken to exclude HCC; 4. The patients are voluntary to sign the informed consents, obey to the medication and interview plan; 5. Patients including the female and the chaperon of men during the child-bearing period should take contraception in the trial.
Exclusion criteria
Exclusion criteria: (1) Breastfeeding or pregnant women; (2) Use of interferon, immunomodulator,or any nucleoside analog that is active against hepatitis virus within 6months before enrollment; (3) Decompensated liver cirrhosis,evidence of ascites, variceal bleeding and hepatic encephalopathy; (4) epilepsy or using any anti-epileptic drug; (5) any immunologically mediated disease; (6) malignant disease, including HCC; (7) Evidence of astable or conspicuous angiocardiopathy such as angina cordis, heart failure, recent myocardial infarction and severe hypertension; (8) severe retinal disease; (9) longly exposure to the hepatotoxicity, such as excessive drinking(drinking greater than 14 alcohol units for more than 1 year, and 1 alcohol unit just as 1 jar of beer, or 1 cup of wine, or 1 pocillum of firewater) and drug taking; (10) thyroid disease and diabetes that are not well controlled by drugs; (11) liver disease that was not due to hepatitis B, as alcoholic liver disease, HCV, autoimmune disease, hemochromatosis, Alpha-1 antitrypsin deficiency and Wilson's disease; (12) coinfection with hepatitis A, hepatitis C, hepatitis D, hepatitis E or HIV; (13) severe kidney disease; (14) organ transplantation(except corneal and hair transplantation); (15) recent treatment with systemic corticosteroids; (16) any factor that will interfere the patient to participate or complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBV-DNA;serum liver function;spectrum of liver fibrosis;HBV-M;non; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood routine;serum kidney function;C; | — |
Countries
China
Contacts
Public ContactChen Yong-Ping
Outcome results
None listed