Chronic hepatitis B
Conditions
Interventions
The treatment group:PD-1 inhibitors combined with interferon (Peg IFN alpha-2b), with nucleoside analogs
The control group:Interferon (Peg IFN alpha-2b), with nucleoside analogues
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) Patients who all gave informed consent to participate in this study and signed the informed consent form. 2) Age from 18 to 65 years old, gender is not limited. 3) HBsAg positive for more than 6 months, being on antiviral therapy and the duration of therapy is more than 6 months. 4) HBsAg 48 weeks. 7) Poor HBsAg response: defined as a decrease in HBsAg of <1 log IU/ml in the last 24 weeks of Peg-IFNa treatment or rebound of HBsAg in the last 24 weeks.
Exclusion criteria
Exclusion criteria: 1) Combination of other diseases that affect the prognosis, such as HIV infection, malignant tumors and so on; 2) Those who have a previous history of allergy to biological agents, or those who are allergic to tirilizumab or sindilizumab; 3) Those with combined autoimmune diseases, or hematologic diseases; 4) Use of other drugs with significant effects on the immune system, such as thymidine, immunosuppressants, glucocorticoids and so on; 5) Those with contraindications to interferon use or those who cannot continue to use interferon: evidence of acute severe liver damage: ALT = 10 ULN; pregnant or breastfeeding patients; a history of definite autoimmune disease; a history of severe psychiatric disorders; a history of severe epileptic seizures or current use of anticonvulsant medications; a history of thyroid disease that is poorly controlled despite standardized treatment; severe retinopathy or a clinically relevant history of ophthalmic disease; 6) Patients who are participating in other trials; 7) Inability or unwillingness to provide informed consent or to follow the requirements of the study; 8) Patients with a history of allergy to nucleoside (acid) analogs or to interferon in the test group; and who meet any of the contraindications in the experimental drug insert in addition to the above exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBsAg clearance at 24 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| 24-week HBsAg serological conversion rate;24-week HBsAg reduction rate;HBsAg clearance and serological conversion at 48 weeks;Relapse rate of HBsAg at 48 weeks ; | — |
Countries
China
Contacts
Public ContactShuangsuo Dang
The Second Affiliated Hospital of Xi 'an Jiaotong University
Outcome results
None listed