CHB(Chronic hepatitis b)
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 1 to 16 years old, male or female; 2. HBsAg, HBeAg positive for at least 6 months; 3. Serum HBV DNA > 1 × 105IU / ml; 4. ALT level > 2.0 × ULN and <10 × ULN 2 consecutive detection with interval of at least 1 month; 5. No history of antiviral treatment or do not recieve antiviral treatment at least in six months before enrollment of this study.
Exclusion criteria
Exclusion criteria: 1. Was treated by antiviral therapy, or immunomodulatory treatment in 6 months before start of the study; 2. evidence of liver cirrhosis or decompensated liver disease, such as imaging examination suggesting cirrhosis or cirrhosis complications, including jaundice (TBIL> 2 × ULN), ascites, gastrointestinal bleeding, hepatic encephalopathy, spontaneous bacterial Peritonitis; or child-Pugh score grade B or C; co-infection with Hepatitis A, C, D, or HIV; 3. Have comorbidity of other liver disease (such as fatty liver, autoimmune liver disease, metabolic liver disease, etc.); 4. Unable to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Combined response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Clearance of HBsAg;HBsAg seroconversion rate;Clearance of HBeAg;Clearance of HBV DNA; | — |
Countries
China
Contacts
Nanfang Hospital