drugset
drugset / Trial / NCT07573943

ASC22 Combined With Peg-IFNa in Achieving Functional Cure in Patients With Chronic Hepatitis B Virus Infection

NCT07573943 ↗

Phase 4 Recruiting 120 enrolled The Second Affiliated Hospital of Chongqing Medical University
Non-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

EvaluationDrugModalityDoseRoute
Subject Envafolimab Monoclonal antibody 1 mg/kg Subcutaneous
Subject PEG-IFNα Protein / enzyme biologic 180 ug Subcutaneous
Background Entecavir Small molecule — Oral
Background Tenofovir disoproxil fumarate Small molecule — Oral
Background tenofovir alafenamide Small molecule — Oral

Indications

chronic hepatitis B virus infection