Chronic hepatitis B
Conditions
Interventions
The treatment group:Interferon (Peg IFNa-2b), with or without nucleoside analogues
The control group:Nucleoside (acid) analogues alone
Sponsors
The Second Affiliated Hospital of Xi 'an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Informed consent to participate in this study and signed the informed consent form. 2) Age range from 18 to 65, regardless of gender. 3) CHB patients with HBsAg positive for more than 6 months; HBV DNA quantification can be measured or not; Treated or newly treated patients. 4) Patients at high risk of HBV-related liver cancer (CHB patients with any one of the following) : (1) age >=30 years, family history of liver cancer or cirrhosis; (2) Abnormal hepatocellular carcinoma related serological indexes (AFP, AFP-L3, GP73, DCP, etc.); (3) Imaging findings of liver nodules; (4) Compensated cirrhosis caused by HBV (Child Pugh grade A).
Exclusion criteria
Exclusion criteria: 1) Patients with decompensated liver cirrhosis, Child Pugh grade B or C, that is, ascites, hepatic encephalopathy, esophageal and gastric variceal bleeding and other obvious signs of liver decompensation; 2) Patients with AFP > 100ng/ml or elevated AFP cannot exclude liver cancer; 3) Patients who have been diagnosed with HCC or other systemic malignancies; 4) Patients with other liver diseases such as self-immune liver, alcoholic liver, or co-infection of hepatitis C, D, A, E or HIV; 5) A history of severe heart disease (e.g. NYHA class III or IV, myocardial infarction, ventricular tachyarrhythmia, unstable angina, or other major cardiovascular disease within 6 months); 6) Organ transplantation or other serious diseases, or any other conditions that the investigator considers inappropriate for this study; 7) Patients in the treatment group had a history of interferon allergy or were condoned to use: evidence of acute severe liver damage: ALT>=10 ULN; Pregnant or lactating patients; A clear history of autoimmune disease; A history of severe mental illness; A history of severe seizures or current use of anticonvulsants; A history of thyroid disease that was poorly controlled after standard treatment; A history of severe retinopathy or clinically relevant eye disease; 8) Patients with history of allergy to nucleoside (acid) analogues; In addition to the above exclusion criteria, patients who meet any contraindication in the instruction manual of the experimental drug. 9) Patients who are enrolled in other trials; 10) Unable or unwilling to provide informed consent or comply with study requirements.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| REAL-B score;Noninvasive liver fibrosis detection; | — |
Primary
| Measure | Time frame |
|---|---|
| Liver imaging;Hepatitis B virus index;Liver function;blood routine examination; | — |
Countries
China
Contacts
Public ContactDang Shuangsuo
The Second Affiliated Hospital of Xi 'an Jiaotong University
Outcome results
None listed