chronic hepatitis B
Conditions
Interventions
NAs monotherapy group:NAs for 96 weeks
Sequential combination group:NAs/IFN for 24-48 weeks, then NAs/IFN combined with IFN/NAs for 96 weeks
Sponsors
The Fifth Medical Center of the Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Age
1 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. Aged 1 to 12 years old; 2. Chronic Hepatitis B (CHB) patients or HBsAg positive > 6 months patients are line with the diagnostic criteria for chronic hepatitis B infection; 3. ALT > 40U/L and =400U/L or ALT=40U/L, but G=1 for liver biopsy; 4. HBV DNA positive; 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 the Chinese PLA General Hospital
Outcome results
None listed