chronic hepatitis B
Conditions
Interventions
Continuing Joint Group:From baseline day 1, 1 capsule of NAs (TAF or TMF) was administered orally once daily in combination with 180 µg of Peg-IFNa-2b once weekly for 48 weeks (total of 48 injections)
Pulse Combined Group:From baseline day 1, 1 capsule of NAs (TAF or TMF) was administered orally once daily in combination with 180 µg of Peg-IFNa-2b, which was discontinued after every 8 weeks for 4 w
Sponsors
Shanghai East Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 to 65 years; 2. HBsAg-positive for >6 months with HBsAg <1500 IU/mL, HBeAg-negative, HBV-DNA-positive, in accordance with the 2022 edition of the guidelines for the prevention and treatment of chronic hepatitis B, and have not used antiviral medication within 1 year 3. Female subjects of childbearing age with negative pre-test urine pregnancy test and able to use effective contraception; those who agree to contraception during treatment and within 6 months after the end of treatment (including female and female partners of male patients); 4. Willing to accept the treatment and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Those with known hypersensitivity to interferon and nucleoside antivirals; 2. Those with other combined viral infections such as HAV, HCV, HDV, HEV, and HIV; 3. Those with cirrhosis or Child-Pugh score of 7 and above; 4. History or evidence of other causes of liver disease (e.g., autoimmune liver disease, alcoholic liver disease, non-alcoholic fatty liver disease, drug-induced hepatitis, hepatomegaly, etc.); 5. Pregnant or nursing women; 6. Unabstinent alcoholics or drug addicts; 7. Neutrophil count = 7; 11. History of endocrine system or autoimmune disease, such as thyroid disease, systemic lupus erythematosus, tuberculosis, autoimmune thrombocytopenic purpura, and psoriasis; 12. Chronic diseases requiring long-term treatment, such as uncontrolled hypertension, diabetes mellitus, chronic obstructive pulmonary disease, etc; 13. Malignant tumors; 14. Suspected hepatic malignancy detected by ultrasound at the time of trial enrollment screening, or alpha-fetoprotein (AFP) greater than 100 ng/mL; or AFP that could not be stabilized in the 3 months prior to the trial; 15. History of vital organ transplantation; 16. Other diseases that the investigator considers unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| End of Interferon Treatment (EOT) HBsAg Negative Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| HBsAg negative rate at the end of 24-week follow-up (EOF);HBsAg serologic conversion rate at EOT, EOF;Degree of reduction in HBsAg levels at EOT, EOF;HBV-DNA negative rate at EOT, EOF;Stratified analysis of HBsAg negative rates at baseline across treatments;Analyzing predictors that influence HBsAg negative conversion rates; | — |
Countries
China
Contacts
Public ContactLihong Qu
shanghai East hospital
Outcome results
None listed