Chronic Hepatitis B Infection Clinical Trial
Official title:
A Phase Ib, Open Label Study to Assess the Safety and Efficacy of Sequential Administration of P1101 and Anti-PD1 in Interferon-Naive Adults With Chronic Hepatitis B or D Infection
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
There are 20 scheduled visits (screening, treatment weeks & follow-up weeks) for patients with > 0.5 log10 decline in HBsAg at TW12, which include screening visit, TW0 (baseline), TW2, TW4, TW6, TW8, TW10, TW12, TW13, TW15, TW17, TW19, TW21, TW23 (EOT), FW4, FW8, FW12, FW16, FW20 and FW24. There are 22 scheduled visits for patients with ≤ 0.5 log10 decline in HBsAg at TW12. These visits include screening visit, TW0 (baseline), TW2, TW4, TW6, TW8, TW10, TW12, TW13, TW16, TW17, TW19, TW21, TW23, TW25, TW27 (EOT), FW4, FW8, FW12, FW16, FW20 and FW24. ;
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