Chronic hepatitis B
Conditions
Interventions
HBV RNA-positive group:All patients in the group continued with the original NA drug once daily for 72 weeks after enrolment and started treatment with PEG-IFN-a-2b injection (Pegaptan?) at 180 µg sub
HBV RNA-negative group:All patients in the group continued with the original NA drug once daily for 72 weeks after enrolment and started treatment with PEG-IFN-a-2b injection (Pegaptan?) at 180 µg sub
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1) Age 18 to 60 years, both sexes (both 18 and 60 years) 2) HBsAg positive for more than 6 months 3) NA treatment for more than 1 year, NA drug type not limited, baseline HBsAg level prior to NA treatment not limited, E antigen level not limited, but HBeAg negative, HBV DNA < 500 IU/ml and HBsAg <= 1500 IU/ml required for enrolment. 4) negative urine or serum pregnancy test within 24 hours prior to the first dose (for women of childbearing age) 5) willingness to accept treatment and sign an informed consent form
Exclusion criteria
Exclusion criteria: 1) Combined active hepatitis A, C, D, E and/or HIV infection. 2) Patients who have previously received, or are currently using, or intend to continue using, tibivudine in the future 3) methaemoglobin (AFP) greater than 100ng/ml at screening; or methaemoglobin that has not remained stable in the 3 months prior to the trial and/or liver imaging suggestive of liver tumour. 4) decompensated liver disease (Child-Pugh score >= 7), meaning that patients will be excluded if one of the following is met: prolonged prothrombin time >= 3 seconds, serum bilirubin > 34umol/L, history of hepatic encephalopathy, history of oesophageal variceal bleeding, ascites. 5) pregnant or lactating women or patients with planned pregnancy during the study period and unwilling to use contraception 6) Neutrophil count 1.5 x ULN. 7) History of severe psychiatric illness, especially depression. Severe psychosis defined as major depressive disorder or psychosis, suicide attempts, hospitalisation for psychosis or loss of capacity for a period of time due to psychosis. 8) history of immune-mediated disease (e.g. inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune haemolytic anaemia, scleroderma, severe psoriasis, rheumatoid arthritis) or abnormally high levels of autoimmune antibodies 9) Patients with severe combined diseases of the heart, lungs, kidneys, brain, blood and other vital organs, combined with other malignancies 10) History of severe epilepsy or current treatment with anti-epileptic drugs. Unstable control of diabetes mellitus, hypertension, thyroid disease, etc. Patients with a history of severe retinopathy or as indicated by other evidence of retinopathy. 11) History of any organ transplantation and existing functional grafts (except corneal or hair transplants). 12) Patients who are allergic to interferon and its drug components and who, in the judgment of the investigator, are unsuitable for interferon application 13) Patients who, in the opinion of the investigator, are not suitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBsAg negative rate and HBsAb seroconversion rate at the end of 48 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| HBsAg negative rate and HBsAb seroconversion rate at the end of 24 weeks of treatment; | — |
Countries
China
Contacts
Public ContactYufeng Gao
Outcome results
None listed