Evaluate the Efficacy and Safety of HLX10 in Chronic Hepatitis B Patients
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|ClinicalTrials.gov Identifier: NCT04133259|
Recruitment Status : Not yet recruiting
First Posted : October 21, 2019
Last Update Posted : November 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis B, Chronic||Drug: Recombinant anti-programmed death-1 (PD-1) humanized monoclonal antibody Drug: Nucleoside/nucleotide analogues||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Simon's Two-Stage Optimal design|
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||November 20, 2019|
|Estimated Primary Completion Date :||April 30, 2022|
|Estimated Study Completion Date :||April 30, 2022|
Experimental: HLX10, in patients with CHB
HLX10: 1 mg/kg at 0, 4th, 8th week (maximum 3 doses). Concomitant antiviral medications: take Nucleoside/nucleotide analogues (NAs) starting from at least 2 weeks before the first dose of HLX10 until 12 weeks after the last dose of HLX10 infusion.
Drug: Recombinant anti-programmed death-1 (PD-1) humanized monoclonal antibody
Treatment of CHB patient with HLX10
Drug: Nucleoside/nucleotide analogues
Treatment NAs for chronic hepatitis B subject to achieve adequate HBV viral suppression
- The proportion of the subjects who achieve 0.5 log decline in HBsAg log10 IU/mL from baseline [ Time Frame: 12 week ]Efficacy of HLX10 for treatment of chronic HBV
- The proportion of subjects with chronic hepatitis B who suffered from hepatitis flare after receiving HLX10 [ Time Frame: 9 months ]Safety of HLX10 in treatment of chronic HBV
- The proportion of subjects with chronic hepatitis B that achieve HBsAg seroclearance after receiving treatment with HLX10. [ Time Frame: 9 months ]HLX10 for curative treatment of chronic HBV
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04133259
|Contact: Jia-Ling Lee||+886-2-792-7927 ext email@example.com|
|Principal Investigator:||Jia-Horng Kao||National Taiwan University Hospital|
|Principal Investigator:||Cheng-Yuan Peng||China Medical University Hospital|