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: 70
Healthy Volunteers: f
View:
• Body mass index (BMI) of 18 to 32 kg/m\^2;
• 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: 150
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
Experimental: Cohort 3
Peg-IFNα/Anti-PD-L1 antibody combined with nucleotide analogs Drug: Anti-PD-L1 antibody Once two weeks, 1mg/kg, subcutaneous injection for the second 24 weeks Drug: Peg-IFNα Once/week, 180μg/time, subcutaneous injection for the first 24 weeks Drug: nucleotide analogs Once/day, 1 capsule/time, oral
Experimental: Cohort 4
Peg-IFNα combined with nucleotide analogs Drug: Peg-IFNα Once/week, 180μg/time, subcutaneous injection for 48 weeks Drug: nucleotide analogs Once/day, 1 capsule/time, oral
Experimental: Cohort 5
Nucleotide analogs Drug: nucleotide analogs Once/day, 1 capsule/time, oral
Related Therapeutic Areas
Sponsors
Collaborators: Three Gorges Hospital of Chongqing University, First Affiliated Hospital of Chongqing Medical University, Guizhou Provincial People's Hospital
Leads: The Second Affiliated Hospital of Chongqing Medical University