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

• Status: Recruiting
• Trial end date: 2023-03-01

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

• Phase: Phase 1

Details

• Lead Sponsor: PharmaEssentia
• Treatments: Entecavir; Nivolumab