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Clinical trial

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

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Last updated:19th Oct 2020
Identifier: NCT04133259
Evaluate the Efficacy and Safety of HLX10 in Chronic Hepatitis B Patients


Brief 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.


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)
Primary Purpose: Treatment
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 1, 2019
Estimated Primary Completion Date: April 30, 2022
Estimated Study Completion Date: April 30, 2022

Arms:
- Experimental:
HLX10, in patients with CHB

Category Value
Study type(s) Interventional
Expected enrolment 44
Study start date 2019-11-01
Estimated primary completion date 2022-04-30

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