About this trial
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.
Eligibility criteria
Qualifiers
Body mass index (BMI) of 18 to 32 kg/m²;
Serum HBsAg<100 IU/mL;
HBV DNA<20 IU/mL;
HBeAg-negative.
Disqualifiers
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 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;
Confirmed or suspected decompensated cirrhosis;
Trial design
Treatments tested in this trial
- Anti-PD-L1 antibody (ASC22)
- Nucleotide analogs
- Peg-IFNα
Treatment groups
Sponsors and collaborators
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