chronic hepatitis B
Conditions
Interventions
combination group:Tenofovir 300mg 1 / day, combined with telbivudine 600mg 1 / day
monotherapy group :Tenofovir 300mg 1 / day
Sponsors
PLA 81th Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-65 years old male and female; 2. Diagnosis is according with the "chronic hepatitis B prevention and treatment guidelines (2005 edition)" and 1) never received a system of anti-hepatitis B virus treatment; 2) HBV DNA =1×10^5 IU/ml; 3) HBeAg positive; HBeAb negative; 4) ALT between the upper limit of the normal value of 2-10 times; 3. Compensatory liver disease (with the following hematology and blood biochemical indicators): 1) White blood cells = 3.5 × 10^9/L; 2) Neutrophils = 1.5×10^9/L; 3) Platelet = 80×10^9/L; 4) Hemoglobin = 100g/L; 5) The total bilirubin = 1.5 times the upper limit of normal; 6) Albumin is not lower than the normal lower limit; 7) Blood urea (nitrogen) does not exceed the upper limit of normal; 8) Creatinine = 1.5 times the normal upper limit; 9) Prothrombin time extension = 3 sec; 4. Childbearing age subjects (including female and male patients with female partners) can take effective contraceptive measures; 5. Understand and voluntarily signed by the Ethics Committee approved the informed consent; 6. To comply with the program of research procedures and visit plans.
Exclusion criteria
Exclusion criteria: 1. Anti-HCV, anti-HDV or anti-HIV positive; 2. Anti-nuclear antibody titer> 1: 100 or positive; 3. Alpha-fetoprotein = 100mg/L or imaging diagnosis of potential risk of primary liver cancer; 4. Decompensated liver disease (such as esophageal variceal bleeding, hepatic encephalopathy, ascites, liver and kidney syndrome, etc.); 5. The following system diseases or past history or researchers believe that should not participate in the trial of serious diseases, such as: 1) Cardiovascular system: unstable or severe cardiovascular disease, such as coronary heart disease, recent onset of myocardial infarction, congestive heart failure, severe hypertension, significant arrhythmia or ECG abnormalities; 2) Respiratory system: bronchiectasis, bronchial asthma, chronic obstructive pulmonary disease, respiratory failure, 3) Endocrine and metabolic diseases: poor drug control thyroid disease and diabetes, etc.; 4) Other: autoimmune diseases, active tuberculosis, malignant diseases (such as cancer), neurological or mental illness history, acute and chronic pancreatitis history; 6. Have received systemic anti-hepatitis B virus drugs (interferon, adefovir, lamivudine, entecavir and telbivudine, etc.); 7. Allergy or suspicious of the drug allergy; 8. Pregnant, lactating or during the study of pregnant women or male subjects pregnant pregnant women plan pregnant; 9. There are alcohol (drinking more than 5 years, the daily alcohol content of men greater than 40g, women greater than 20g) and known drug dependence; 10. Organ transplant history (except corneal transplantation and hair planting); 11. Nearly three months participated in any drug clinical researchers; 12. There are any other researchers that are not suitable for inclusion in this study or to complete the study of the factors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| serum marker for heptitis B;the level of HBV-DNA; | — |
Secondary
| Measure | Time frame |
|---|---|
| serum biochemical test;ultrasound measurement;Alpha - fetoprotein;Blood routine; | — |
Countries
China
Contacts
Public ContactPing Li
PLA 81th Hospital
Outcome results
None listed