drugset / Trial / NCT07573943
ASC22 Combined With Peg-IFNa in Achieving Functional Cure in Patients With Chronic Hepatitis B Virus Infection
Phase 4
Recruiting
150 enrolled
The Second Affiliated Hospital of Chongqing Medical University
First Affiliated Hospital of Chongqing Medical University · collabGuizhou Provincial People's Hospital · collabThree Gorges Hospital of Chongqing University · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2024-05-21
- Primary completion
- 2026-12-31
- Completion
- 2026-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Envafolimab | Monoclonal antibody | 1 mg/kg | Subcutaneous |
| Subject | Peginterferon alfa-2a | Protein / enzyme biologic | 180 ug | Subcutaneous |
| Background | Entecavir | Small molecule | 1 unknown | Oral |
| Background | Tenofovir disoproxil fumarate | Small molecule | 1 unknown | Oral |
| Background | tenofovir alafenamide | Small molecule | 1 unknown | Oral |