Chronic Hepatitis B
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male and female patients with age >= 18 and <= 65 years; 2. There should be evidences that HBsAg has been positive for more than 6 months with HBeAg negative after more than one year NAs treatment with HBVDNA negative, HBsAg <= 50000IU/ml and ALT normal 3. Women without ongoing pregnancy or breast feeding and both women and men willing to take an effective contraceptive measure during the treatment.
Exclusion criteria
Exclusion criteria: 1. Allergic history to interferon or NAs; 2. Co-infection with active hepatitis A, hepatitis C, hepatitis D and/or human immunodeficiency virus (HIV); 3. Liver cirrhosis or Child-Pugh scores > 7; 4. History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures, thalassemia); 5. Pregnant or breast-feeding Women; 6. Consuming alcohol in excess of 20g/day for women and 30g/day for men within 12 months prior to enrollment or drug taking history; 7. ANC(absolute neutrophil count) 100ng/ml and/or evidence of hepatocellular carcinoma; 15. Major organ transplantation; 16. Other disease should exclusive considered by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects who achieve HBsAg loss at 96 week; | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of subjects who achieve HBsAg loss at 48 week;The level and decreasion of HBsAg at 48 and72 week;Number of subjects who achieve HBsAg seroconversion; | — |
Countries
China
Contacts
Ruijin Hospital North, Shanghai Jiaotong University, School of Medicine