Hepatitis B virus infection (immune tolerant phase)
Conditions
Interventions
Treated Group:enticavir for 48 weeks followed by adding PegIFN-alfa to entecavir for another 48 weeks
control group:Nil
Sponsors
Beijing 302 Hospital of PLA
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18-45 years; 2. Family history of progressive HBV-related liver disease, including liver cirrhosis, hepatocellular carcinoma, chronic hepatitis (active); HBsAg positive longer than 6 months, ALT 20-40 U/L, HAI score less than 4, Ishak score less than 2, HBeAg, anti-HBc positive, HBV DNA more than 10^6 IU/mL; 3. Received no antiviral treatment[nucleos(t)ide analog or interferon treatment] or immunomodulator within three months before recruiting; 4. Agree no intaking of the following drugs: other clinical novel drugs, cytotoxic drugs, glucocorticoid, immunomodulator; 5. Be willing to participate and sign the Concert Form.
Exclusion criteria
Exclusion criteria: 1. HIV positive; 2. HCV postive; 3. Autoimmune liver disease(antinuclear antibody greater than 1:100; 4. Creatinine more than 1.5mg/dl (more than 130mmol/L); 5. Liver disease caused by other reasons, alcoholic liver disease (alcohol intake more than 20g/d for female, more than 30 g/d for male, and over 1 year) or alcohol addiction (intake more than 40g/d); 6. Severe complications, such as: severe hypertension, blood disease, unstable diabetes, unstable angina, kidney disease; epilepsy, clinically significant neuropathy, drug abuse, mentally ill; 7. Allergy to IFN-alpha or IFN-alpha contraindications; 8. Pregnant women or lactating women; 9. Women of childbearing age who did not take effective contraceptive measures; 10. WBC less than 4*10^9/L, PLT less than 100*10^9/L; 11. Researchers considered unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum HBV DNA level;HBeAg loss/seroconversion;Serum HBsAg level;Intrahepatic HBV cccDNA level;Serum ALT level; | — |
Countries
China
Contacts
Public ContactXin Shaojie; Xu dongping
Outcome results
None listed