Chronic hepatitis B
Conditions
Interventions
Group 1:Tenofovir alafenamide
Group 2:Pegylated Interferon adding tenofovir alafenamide
Group 3:Pegylated Interferon adding tenofovir alafenamide stepwise
Sponsors
Shanghai Public Clinical Center
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 50 years; 2. HBsAg lasts for more than 6 months; 3. The duration of the NAs exceeds 2 years; 4. The value of HBeAg exceed 200S/co at the start of the treatment; 5. At the screening, HBeAg is postive, the load of HBVDNA is undetected, the value of HBsAg is less than 3000IU/ml,and the value of HBeAg is less than 200S/co.
Exclusion criteria
Exclusion criteria: 1. HAV or HCV or HDV or HEV or HIV is postive; 2. The value of AFP exceed 100 ng/ml; Or the alpha-fetoprotein does not remain stable within 3 months prior to the trial and/or liver imaging is suggestive of a liver tumor; 3. The value of Fibroscan exceed 10Kpa or the result of ultrasound is cirrhosis; 4. The value of ANC is less than 1.5 x 10^9 or the value of PLT is less than 90 x 10^9; 5. The history of alcoholic abuse in 1 year; 6. A history of severe mental illness, especially depression; 7. A history of immune-mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis) or abnormally elevated levels of autoimmune antibodies; 8. Severe heart, lung, renal, brain and hematopathy disease; 9. The value of creatinine is above 1.5ULN; 10. Uncontrolled diabetes, hypertension, thyroid diseases; 11. Severe retina disease, or by other evidence of retinopathy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBeAg seroconvention rate; | — |
Countries
China
Contacts
Public ContactHuang Yuxian
Shanghai Public Clinical Center
Outcome results
None listed