Hepatitis B, Chronic Clinical Trial
Official title:
An Exploratory Study to Evaluate The Efficacy And Safety of HLX10, A Humanized Monoclonal Antibody Targeting Programmed Death-1 (PD-1) Protein In Chronic Hepatitis B Patients
A multiple-center, open-label, Phase II clinical trial to evaluate the safety and the efficacy of HLX10 in chronic hepatitis B patients.
This study is multiple-center, open-label, Phase II clinical trial and uses Simon's Two-Stage Optimal design. Subjects with chronic hepatitis B (CHB) will be enrolled sequentially and receive up to 3 doses of HLX10 at 1 mg/kg for four weeks apart. First six subjects will be enrolled in the safety run-in period. If there are no serious adverse events noticed in these 6 subjects up to 6 weeks after the last infusion of HLX10, additional 11 subjects will be enrolled. These 17 subjects (6+11) will be evaluated for efficacy. In the second stage of trial, 27 additional subjects will be enrolled. Total 44 subjects [stage I (n=17) + stage II (n= 27) = total (n=44)] will be accrued in this study. ;
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