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Clinical Trial 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


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04638439
Study type Interventional
Source PharmaEssentia
Contact Wendy Hung, MS
Phone +886-2-2655-7688
Email Wanchu_Hung@pharmaessentia.com
Status Recruiting
Phase Phase 1
Start date December 2021
Completion date March 2023

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