chronic Hepatitis B
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 65 years old 2. HBsAg positive = 6 months before initial NAs treatment 3. Serum HBsAg = 1500 IU/mL, HBeAg-negative and HBV DNA < 200IU/mL after at least 1 year of NAs therapy (NAs include ETV, TDF, TAF, TMF, and ADV)
Exclusion criteria
Exclusion criteria: 1. Received other antiviral or immunomodulatory treatments (including interferon) within one year prior to enrollment 2. Co-infection with other hepatitis viruses, HIV, CMV, etc 3. Decompensated cirrhosis, psychiatric history, uncontrolled epilepsy, uncontrolled autoimmune disease and diabetes, as well as severe infection, retinal disease, heart failure, chronic obstructive pulmonary disease and other basic diseases 4. Pregnancy or having a pregnancy plan in the short term
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of negative serum HBsAg;Level of serum HBsAg;Change in level of serum HBV DNA ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Scores of liver fibrosis(APRI, FIB-4);Serum aminotransferase levels;Incidence of adverse reactions (fever, leukopenia, abnormal thyroid function, etc.); | — |
Countries
China
Contacts
West China Hospital of Sichuan University