chronic hepatitis B
Conditions
Interventions
NAs monotherapy group: NAs for 96 weeks:None
NA+IFN combined treatment group: NAs + IFN for 96 weeks:None
Drug withdrawal observation group: The virological indexs and biochemical results were closely observed, and antiviral treatment would be restart according to the standards(ALT =10×ULN/TBil =2×ULN) a
Sponsors
The Fifth Medical Center of Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
1 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. Age =1 years and < 13 years; 2. Previously diagnosed chronic hepatitis B was treated with NAs or IFNa antiviral therapy; 3. NAs treatment for more than 1 year, no history of IFNa use in recent 1 year; The discontinuation observation group also had to meet the antiviral course for at least 4 years and achieve HBeAg serological conversion; 4. HBV DNA negative, HBeAg negative, HBsAg < 10000IU/ml; 5. Guardians sign the Informed Consent Form.
Exclusion criteria
Exclusion criteria: 1. WBC34umol/L; ALB133umol/L; 2. Combined with HAV HCV HDV HEV or HIV-infected persons; 3. Combined with autoimmune liver disease, drug-induced liver injury, Wilson's disease and so on; 4. Patients with decompensated cirrhosis; 5. Combined with serious diseases of other systems or hereditary diseases; 6. Patients who are allergy to IFNs and NAs; 7. Research judged patients who unable to comply with the study arrangement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBsAg negative conversion rate(clinical cure rate); | — |
Secondary
| Measure | Time frame |
|---|---|
| HBeAg negative conversion rate/ seroconversion rate;HBV DNA negative conversion rate;Renormalization rate of alanine aminotransferase; | — |
Countries
China
Contacts
Public ContactZhang Min
The Fifth Medical Center of Chinese PLA General Hospital
Outcome results
None listed