chronic hepatitis B
Conditions
Interventions
Group 1:Entecavir(0.5mg qd po) for 48 weeks
Group 2::Interferon alfa-2b(600wIU qod iH) for 48 weeks/Entecavir(0.5mg qd po) for 8 weeks
Group 3:Interferon alfa-2b(600wIU qod iH) for 48 weeks/Entecavir(0.5mg qd po) for 8 weeks/ Hepatitis B Vaccine (60ug qm im) for 48 weeks
Sponsors
Departmen of infectious disease, Tongji Hospital, Tongji medical college, Huazhong university of science and technology
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Adult patients, >=18 and =100000copies/ml, ALT>=2 ULN and <=10 ULN before receiving entecavir treatment; 4. HBV DNA <=1000 copies/mL; 5. HBeAg (-); 6. HBsAg (+); 7. Within 24 hours before first dose of drug, HCG (-) for women of childbearing age; 8. Liver biopsy confirmed without cirrhosis (optional); 9. Patients must give written informed consent before any assessment is performed.
Exclusion criteria
Exclusion criteria: 1) Antiviral treatment other than Entecavir; 2) Antineoplastic or immunomodulatory treatment; 3) Pregnant or lactating women; 4) Co-infection with active hepatitis A, C, D or E, or HIV; 5) ALT>=10 ULN; 6) History or evidence of decompensated liver disease (Child-Pugh score >5): ALB=34 umol/L, hepatic encephalopathy, bleeding esophageal varices, or ascites; 7) Evidence of other chronic liver diseases including a history of autoimmune hepatitis, alcoholic liver disease, etc. 8) Ultrasound, CT or MRI and other imaging examination showed liver cirrhosis or liver abscess; 9) Patients with history of hepatocellular carcinoma (HCC) or related symptoms, AFP>100ng/ml; 10) ANC=1.5*ULN; 13) P1:100; 15) Have a history of serious mental illness, particularly depression; 16) history of severe seizures or anticonvulsant drugs currently in use; 17) A history of autoimmune diseases (such as inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, rheumatoid arthritis, etc.); 18) History of chronic lung disease associated with functional limitations; 19) History of severe heart disease (such as NYHA functional class III or IV, myocardial infarction within 6 months, the need for continued treatment of ventricular tachyarrhythmia, unstable angina or other significant cardiovascular disease); 20) Other evidence of organ transplantation, severe disease, cancer, etc.; 21) History of poorly controlled thyroid disease by prescription drug, thyroid hormone increases accompanied by elevated thyroid peroxidase antibodies and any clinical manifestations of thyroid disease; 22) Severe retinal disease or history of clinical related eye diseases (such as hypertension or diabetes, CMV retinitis, macular degeneration); 23) Within 6 months prior to enrollment, patients daily drinking more than 20g (women) or 30g (men); 24) Within one year prior to enrollment, evidence of drug abuse or treatment with methadone; 25) Participating in other trials, or accepting the study medication within 12 weeks before screening; 26) Unable or unwilling to provide informed consent or follow the study requirements; 27) History of allergy to interferon, hepatitis B vaccine or IL-2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| quantitative determination of serum HBV marker; | — |
Secondary
| Measure | Time frame |
|---|---|
| HBV DNA testing;liverl function testing;Blood routine tests;Ultrasound of liver and spleen; | — |
Countries
China
Contacts
Public ContactQin Ning
Outcome results
None listed