drugset / Trial / NCT07809165
Sequential PD-1 Antibody and Pegylated Interferon Therapy for Nucleos(t)Ide Analogue-suppressed Chronic Hepatitis B
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a prospective, multicenter, randomized, open-label controlled clinical trial designed to evaluate the efficacy and safety of a sequential treatment strategy incorporating a PD-1 antibody and pegylated interferon-α (Peg-IFNα) in patients with chronic hepatitis B receiving stable nucleos(t)ide analogue (NA) therapy.
Timeline
- Start
- 2026-09
- Primary completion
- 2029-09
- Completion
- 2029-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Peginterferon alfa-2b | Protein / enzyme biologic | 135 ug | Subcutaneous |
| Comparator | Peginterferon alfa-2b | Protein / enzyme biologic | 180 ug | Subcutaneous |
| Subject | Sintilimab | Monoclonal antibody | 1 mg/kg | Intravenous |
| Comparator | Entecavir | Small molecule | — | — |
| Comparator | Tenofovir disoproxil fumarate | Small molecule | — | — |
| Comparator | tenofovir alafenamide | Small molecule | — | — |