ASC22 Combined With Peg-IFNa in Achieving Functional Cure in Patients With Chronic Hepatitis B Virus Infection
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:
• 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
• 18-60 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
• HBV DNA\<20 IU/mL
• HBeAg-negative
Locations
Other Locations
China
The 2nd affiliated Hospital of Chongqing Medical University
RECRUITING
Chongqing
Contact Information
Primary
Dachuan Cai, MD
cqmucdc@cqmu.edu.cn
+86 18323409779
Backup
Min Chen, PhD
mchen@hospital.cqmu.edu.cn
+86 17338600343
Time Frame
Start Date:2024-05-21
Estimated Completion Date:2026-12-31
Participants
Target number of participants:120
Treatments
Experimental: Cohort 1
Nucleotide analogs combined with anti-PD-L1 antibody (ASC22). Drug: Anti-PD-L1 antibody Once two weeks, 1mg/kg, subcutaneous injection for the first 24 weeks Drug: Nucleotide analogs Once/day, 1 capsule/time, oral
Experimental: Cohort 2
Anti-PD-L1 antibody/pegylated interferon alfa (Peg-IFNα) combined with nucleotide analogs Drug: Anti-PD-L1 antibody Once two weeks, 1mg/kg, subcutaneous injection for the first 24 weeks Drug: Peg-IFNα Once/week, 180μg/time, subcutaneous injection for the second 24 weeks Drug: nucleotide analogs Once/day, 1 capsule/time, oral