drugset / Trial / NCT04638439
The Safety and Efficacy of Sequential Treatment of Ropeginterferon Alfa-2b (P1101) and Anti-PD1 in Interferon-Naive Adults With Chronic Hepatitis B or D Infection
NaSingle-groupOpen-labelTreatment
Summary
Primary objective: To evaluate the safety and tolerability of sequential administration of P1101 and anti-PD1 in patient with chronic hepatitis B or D infection Secondary objectives: 1. To explore HBsAg loss and kinetics during the study period 2. To assess the anti-viral effect during the study period 3. To evaluate the rate of ALT normalization
Timeline
- Start
- 2022-08-17
- Primary completion
- 2026-04-08
- Completion
- 2026-04-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nivolumab | Monoclonal antibody | 0.3 mg/kg | — |
| Subject | Ropeginterferon alfa-2b | Protein / enzyme biologic | 450 ug | Subcutaneous |
| Background | Entecavir | Small molecule | 0.5 mg | — |