NCT04133259

Evaluate the Efficacy and Safety of HLX10 in Chronic Hepatitis B Patients

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Henlix, Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A multiple-center, open-label, Phase II clinical trial to evaluate the safety and the efficacy of HLX10 in chronic hepatitis B patients.

Detailed description

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.

Conditions

• Hepatitis B, Chronic

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-12-31
• Primary completion: 2022-04-30
• Completion: 2022-07-30
• First posted: 2019-10-21
• Last updated: 2020-10-20

Locations

3 sites across 1 country: Taiwan