Exploring the safety and efficacy of the therapy combining immune checkpoint inhibitors (anti-PD-L1 monoclonal antibody, ASC22) and pegylated interferon alfa (Peg-IFNα) in patients with CHB. Exploring new combination therapeutic schemes for hepatitis B cure, and raising the overall clinical cure rate to more than 50% without screening specific advantageous groups.
Sign the informed consent form before inclusion and be able to complete the study according to the study requirements
From inclusion to 30 days after the last administration of the study drug, male subjects or female subjects of childbearing age are willing to voluntarily take effective contraceptive measures
18-70 years old. The weight of male subjects is not less than 45 kg, and the weight of female subjects is not less than 40 kg. Body mass index (BMI) is within the range of 18-32 kg/m2
Serum HBsAg<100 IU/mL
A history of allergy, or who are suspected by the researcher to be allergic to the active ingredient of the drug under study or its excipients
Use of inhibitors, inducers or substrates of CYP3A4 within 28 days before enrollment
Systematical use of immunosuppressants, immunomodulators (thymosin) and cytotoxic drugs within 6 months before enrollment, or vaccination of live attenuated vaccine within 1 month before enrollment
Acute infection within 2 weeks before enrollment which requires intravenous antibiotic treatment, or existing infection which requires anti-infection treatment when enrollment
The Second Affiliated Hospital of Chongqing Medical University
Lead sponsor
First Affiliated Hospital of Chongqing Medical University
Collaborator
Three Gorges Hospital of Chongqing University
Collaborator
Guizhou Provincial People's Hospital
Collaborator