Chronic Hepatitis B
Conditions
Interventions
Experimental group:peginterferon a-2b combined with nucleos(t)ide analogs
Control group:Nucleos(t)ides
Sponsors
Gansu Wuwei Tumour Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Understand and voluntarily sign the informed consent form. 2. Age 18~65 years old (including 18 and 65), no gender limited. 3. HBsAg positive for at least 6 months or other evidence suggestive chronic hepatitis infection, HBeAg+/. 4. Receiving continuously nucleos(t)ide analogs(ETV/TDF/TAF/TMF) therapy for at least 3 months prior to screening and are currently receiving the nucleos(t)ide analog; 5. HBsAg>1500IU/mL at screening; 6. Pregnancy test of females of childbearing age must be negative within 24 hours before the first dose, and subjects (male and female) should take effective contraceptive measures during the study period; 7. For cohort 2, patients must voluntarily consent for liver biopsies, and stage of liver fibrosis score =2 (S=2)at screening.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women or those who had a birth plan during the study period; 2. Subjects with a medical history of neuropsychiatric disorders, especially depression, anxiety, mania, schizophrenia, etc, or those with a family history of psychiatric disorders; 3. Co-infected with hepatitis A, C, D, E, or HIV. 4. Chronic liver disease other than hepatitis B, e.g. alcoholic hepatitis, drug-induced hepatitis, autoimmune liver illness; 5. Moderate to severe steatohepatitis; 6. Evidence of acute severe hepatitis, e.g. ALT>10 ULN, or ALT significantly increased with bilirubin increased markedly; 7. Evidence of liver decompensation, ascites, esophageal and gastric varices rupture bleeding, sepsis, hepatic encephalopathy, hepatorenal syndrome, etc. Or previous evidence of cirrhosis decompensation; 8. There is evidence of hepatocellular carcinoma, or AFP>1ULN; 9. Kidney diseases: acute and chronic nephritis, renal insufficiency, nephrotic syndrome, etc. Or serum creatinine >1ULN at screening; 10. Neutrophil count 1:100 at screening; 13. Autoimmune diseases,e.g. psoriasis, systemic lupus erythematosus, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with HBsAg lower than 1500IU/ml at week 24 post treatment;Changes of HBsAg level compared to baseline at week 24 post treatment;Improvement of liver fibrosis compared to baseline at week 24 post treatment ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes of HBsAg level compared to baseline at visits during the study period;Rate of HBsAg negative and seroconversion duiring the study period;Changes of HBeAg compared to baseline, and rates of HBeAg negative and seroconvesion at visits duiring the study period (for patients with HBeAg positive at baseline);Changes of HBV DAN compared to baseline, and rates of HBV DAN negative at visits duiring the study period;Decrease of cccDNA compared to baseline at week 24 post treatment; | — |
Countries
China
Contacts
Public ContactHaitao Tang
Gansu Wuwei Tumour Hospital
Outcome results
None listed